Summary
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EudraCT Number: | 2009-012603-26 |
Sponsor's Protocol Code Number: | 05-NEOV-003 |
National Competent Authority: | Germany - BfArM |
Clinical Trial Type: | EEA CTA |
Trial Status: | Prematurely Ended |
Date on which this record was first entered in the EudraCT database: | 2010-02-24 |
Trial results | View results |
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A. Protocol Information
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A.1 | Member State Concerned | Germany - BfArM | |
A.2 | EudraCT number | 2009-012603-26 | |
A.3 | Full title of the trial |
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A.4.1 | Sponsor's protocol code number | 05-NEOV-003 | |
A.5.1 | ISRCTN (International Standard Randomised Controlled Trial) Number | N/A | |
A.7 | Trial is part of a Paediatric Investigation Plan | Information not present in EudraCT | |
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information
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B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | Fresenius Kabi Deutschland GmbH |
B.1.3.4 | Country | Germany |
B.3.1 and B.3.2 | Status of the sponsor | Commercial |
B.4 Source(s) of Monetary or Material Support for the clinical trial: | ||
B.4.1 | Name of organisation providing support | |
B.4.2 | Country | |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | |
B.5.2 | Functional name of contact point |
D. IMP Identification
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D.IMP: 1 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | No |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | NEOVEN |
D.3.2 | Product code | NA |
D.3.4 | Pharmaceutical form | Solution for infusion |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Acetylcysteine |
D.3.9.1 | CAS number | 616-91-1 |
D.3.9.2 | Current sponsor code | N-Acetyl-L-Cysteine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glycine |
D.3.9.1 | CAS number | 56-40-6 |
D.3.9.2 | Current sponsor code | Glycine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Histidine |
D.3.9.1 | CAS number | 71-00-1 |
D.3.9.2 | Current sponsor code | Histidine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Isoleucine |
D.3.9.1 | CAS number | 73-32-5 |
D.3.9.2 | Current sponsor code | L-Isoleucine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Leucine |
D.3.9.1 | CAS number | 61-90-5 |
D.3.9.2 | Current sponsor code | L-Leucine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10.8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Lysine acetate |
D.3.9.1 | CAS number | 57282-49-2 |
D.3.9.2 | Current sponsor code | L-Lysine acetate |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 8.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Methionine |
D.3.9.1 | CAS number | 63-68-3 |
D.3.9.2 | Current sponsor code | L-Methionine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Phenylalanine |
D.3.9.1 | CAS number | 63-91-2 |
D.3.9.2 | Current sponsor code | L-Phenylalanine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Proline |
D.3.9.1 | CAS number | 147-85-3 |
D.3.9.2 | Current sponsor code | L-Proline |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 8.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Serine |
D.3.9.1 | CAS number | 56-45-1 |
D.3.9.2 | Current sponsor code | L-Serine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Taurine |
D.3.9.1 | CAS number | 107-35-7 |
D.3.9.2 | Current sponsor code | Taurine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Threonine |
D.3.9.1 | CAS number | 72-19-5 |
D.3.9.2 | Current sponsor code | L-Threonine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Tryptophan |
D.3.9.1 | CAS number | 73-22-3 |
D.3.9.2 | Current sponsor code | L-Tryptophan |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Valine |
D.3.9.1 | CAS number | 72-18-4 |
D.3.9.2 | Current sponsor code | L-Valine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Alanine |
D.3.9.1 | CAS number | 56-41-7 |
D.3.9.2 | Current sponsor code | L-Alanine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 9.7 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Arginine hydrochloride |
D.3.9.1 | CAS number | 1119-34-2 |
D.3.9.2 | Current sponsor code | L-Arginine hydrochloride |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 8.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | L-Alanyl-L-glutamine |
D.3.9.1 | CAS number | 39537-23-0 |
D.3.9.2 | Current sponsor code | L-Alanyl-L-glutamine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 22.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glycyl-L-tyrosine |
D.3.9.1 | CAS number | 658-79-7 |
D.3.9.2 | Current sponsor code | Glycyl-L-tyrosine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.7 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 2 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Vaminolact |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Fresenius Kabi N.V. |
D.2.1.2 | Country which granted the Marketing Authorisation | Belgium |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Solution for infusion |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | GLYCINE |
D.3.9.1 | CAS number | 56-40-6 |
D.3.9.2 | Current sponsor code | Glycine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Histidine |
D.3.9.1 | CAS number | 71-00-1 |
D.3.9.2 | Current sponsor code | L-Histidine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Isoleucine |
D.3.9.1 | CAS number | 73-32-5 |
D.3.9.2 | Current sponsor code | L-Isoleucine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Leucine |
D.3.9.1 | CAS number | 61-90-5 |
D.3.9.2 | Current sponsor code | L-Leucine |
D.3.9.3 | Other descriptive name | LEUCINE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 7.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Lysine |
D.3.9.1 | CAS number | 57282-49-2 |
D.3.9.3 | Other descriptive name | LYSINE ACETATE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Methionine |
D.3.9.1 | CAS number | 63-68-3 |
D.3.9.3 | Other descriptive name | METHIONINE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.3 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Phenylalanine |
D.3.9.1 | CAS number | 63-91-2 |
D.3.9.2 | Current sponsor code | L-Phenylalanin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.7 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Proline |
D.3.9.1 | CAS number | 147853 |
D.3.9.2 | Current sponsor code | L-Proline |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Serine |
D.3.9.1 | CAS number | 56451 |
D.3.9.2 | Current sponsor code | L-Serine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Taurine |
D.3.9.1 | CAS number | 107357 |
D.3.9.2 | Current sponsor code | L-Taurine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.3 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Threonine |
D.3.9.1 | CAS number | 72-19-5 |
D.3.9.2 | Current sponsor code | L-Threonine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Tryptophan |
D.3.9.1 | CAS number | 73-22-3 |
D.3.9.2 | Current sponsor code | L-Tryptophan |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Valine |
D.3.9.1 | CAS number | 72-18-4 |
D.3.9.2 | Current sponsor code | L-Valine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Alanine |
D.3.9.1 | CAS number | 56-41-7 |
D.3.9.2 | Current sponsor code | L-Alanine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 6.3 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Arginine Hydrochlorid |
D.3.9.1 | CAS number | 1119342 |
D.3.9.2 | Current sponsor code | L-Arginine Hydrochlorid |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Aspartic Acid |
D.3.9.1 | CAS number | 56-84-8 |
D.3.9.3 | Other descriptive name | Aspartic Acid |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glutamic Acid |
D.3.9.1 | CAS number | 56-86-0 |
D.3.9.3 | Other descriptive name | Glutamic Acid |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 7.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Cysteine |
D.3.9.1 | CAS number | 52904 |
D.3.9.3 | Other descriptive name | Cysteine free |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Tyrosine |
D.3.9.1 | CAS number | 60-18-4 |
D.3.9.2 | Current sponsor code | L-Tyrosine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.5 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 3 | ||
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Vaminolact |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Medias International D.o.o. |
D.2.1.2 | Country which granted the Marketing Authorisation | Slovenia |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Solution for infusion |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | GLYCINE |
D.3.9.1 | CAS number | 56-40-6 |
D.3.9.2 | Current sponsor code | Glycine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Histidine |
D.3.9.1 | CAS number | 71-00-1 |
D.3.9.2 | Current sponsor code | L-Histidine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Isoleucine |
D.3.9.1 | CAS number | 73-32-5 |
D.3.9.2 | Current sponsor code | L-Isoleucine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Leucine |
D.3.9.1 | CAS number | 61-90-5 |
D.3.9.2 | Current sponsor code | L-Leucine |
D.3.9.3 | Other descriptive name | LEUCINE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 7.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Lysine |
D.3.9.1 | CAS number | 57282-49-2 |
D.3.9.3 | Other descriptive name | LYSINE ACETATE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Methionine |
D.3.9.1 | CAS number | 63-68-3 |
D.3.9.3 | Other descriptive name | METHIONINE |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.3 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Phenylalanine |
D.3.9.1 | CAS number | 63-91-2 |
D.3.9.2 | Current sponsor code | L-Phenylalanin |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.7 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Proline |
D.3.9.1 | CAS number | 147853 |
D.3.9.2 | Current sponsor code | L-Proline |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Serine |
D.3.9.1 | CAS number | 56451 |
D.3.9.2 | Current sponsor code | L-Serine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Taurine |
D.3.9.1 | CAS number | 107357 |
D.3.9.2 | Current sponsor code | L-Taurine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.3 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Threonine |
D.3.9.1 | CAS number | 72-19-5 |
D.3.9.2 | Current sponsor code | L-Threonine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Tryptophan |
D.3.9.1 | CAS number | 73-22-3 |
D.3.9.2 | Current sponsor code | L-Tryptophan |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Valine |
D.3.9.1 | CAS number | 72-18-4 |
D.3.9.2 | Current sponsor code | L-Valine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Alanine |
D.3.9.1 | CAS number | 56-41-7 |
D.3.9.2 | Current sponsor code | L-Alanine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 6.3 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Arginine Hydrochlorid |
D.3.9.1 | CAS number | 1119342 |
D.3.9.2 | Current sponsor code | L-Arginine Hydrochlorid |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Aspartic Acid |
D.3.9.1 | CAS number | 56-84-8 |
D.3.9.3 | Other descriptive name | Aspartic Acid |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Glutamic Acid |
D.3.9.1 | CAS number | 56-86-0 |
D.3.9.3 | Other descriptive name | Glutamic Acid |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 7.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Cysteine |
D.3.9.1 | CAS number | 52904 |
D.3.9.3 | Other descriptive name | Cysteine free |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Tyrosine |
D.3.9.1 | CAS number | 60-18-4 |
D.3.9.2 | Current sponsor code | L-Tyrosine |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.5 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.8 Information on Placebo
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E. General Information on the Trial
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E.1 Medical condition or disease under investigation | ||||||||||||||
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification | ||||||||||||||
E.1.2 Medical condition or disease under investigation | ||||||||||||||
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E.1.3 | Condition being studied is a rare disease | No | ||||||||||||
E.2 Objective of the trial | ||||||||||||||
E.2.1 | Main objective of the trial |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No | ||||||||||||
E.3 | Principal inclusion criteria |
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E.4 | Principal exclusion criteria |
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E.5 End points | ||||||||||||||
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial | ||||||||||||||
E.6 | Scope of the trial | |||||||||||||
E.6.1 | Diagnosis | No | ||||||||||||
E.6.2 | Prophylaxis | No | ||||||||||||
E.6.3 | Therapy | Yes | ||||||||||||
E.6.4 | Safety | Yes | ||||||||||||
E.6.5 | Efficacy | Yes | ||||||||||||
E.6.6 | Pharmacokinetic | Yes | ||||||||||||
E.6.7 | Pharmacodynamic | No | ||||||||||||
E.6.8 | Bioequivalence | No | ||||||||||||
E.6.9 | Dose response | No | ||||||||||||
E.6.10 | Pharmacogenetic | No | ||||||||||||
E.6.11 | Pharmacogenomic | No | ||||||||||||
E.6.12 | Pharmacoeconomic | No | ||||||||||||
E.6.13 | Others | No | ||||||||||||
E.7 | Trial type and phase | |||||||||||||
E.7.1 | Human pharmacology (Phase I) | No | ||||||||||||
E.7.1.1 | First administration to humans | No | ||||||||||||
E.7.1.2 | Bioequivalence study | No | ||||||||||||
E.7.1.3 | Other | No | ||||||||||||
E.7.1.3.1 | Other trial type description | |||||||||||||
E.7.2 | Therapeutic exploratory (Phase II) | No | ||||||||||||
E.7.3 | Therapeutic confirmatory (Phase III) | Yes | ||||||||||||
E.7.4 | Therapeutic use (Phase IV) | No | ||||||||||||
E.8 Design of the trial | ||||||||||||||
E.8.1 | Controlled | Yes | ||||||||||||
E.8.1.1 | Randomised | Yes | ||||||||||||
E.8.1.2 | Open | No | ||||||||||||
E.8.1.3 | Single blind | No | ||||||||||||
E.8.1.4 | Double blind | Yes | ||||||||||||
E.8.1.5 | Parallel group | Yes | ||||||||||||
E.8.1.6 | Cross over | No | ||||||||||||
E.8.1.7 | Other | No | ||||||||||||
E.8.2 | Comparator of controlled trial | |||||||||||||
E.8.2.1 | Other medicinal product(s) | Yes | ||||||||||||
E.8.2.2 | Placebo | No | ||||||||||||
E.8.2.3 | Other | No | ||||||||||||
E.8.3 | The trial involves single site in the Member State concerned | No | ||||||||||||
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes | ||||||||||||
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 | ||||||||||||
E.8.5 | The trial involves multiple Member States | Yes | ||||||||||||
E.8.5.1 | Number of sites anticipated in the EEA | 8 | ||||||||||||
E.8.6 Trial involving sites outside the EEA | ||||||||||||||
E.8.6.1 | Trial being conducted both within and outside the EEA | No | ||||||||||||
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT | ||||||||||||
E.8.7 | Trial has a data monitoring committee | Yes | ||||||||||||
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial | ||||||||||||||
E.8.9.1 | In the Member State concerned years | 1 | ||||||||||||
E.8.9.1 | In the Member State concerned months | 0 | ||||||||||||
E.8.9.1 | In the Member State concerned days | 0 | ||||||||||||
E.8.9.2 | In all countries concerned by the trial years | 1 | ||||||||||||
E.8.9.2 | In all countries concerned by the trial months | 0 | ||||||||||||
E.8.9.2 | In all countries concerned by the trial days | 0 |
F. Population of Trial Subjects
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F.1 Age Range | |||
F.1.1 | Trial has subjects under 18 | Yes | |
F.1.1.1 | In Utero | No | |
F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | Yes | |
F.1.1.3 | Newborns (0-27 days) | No | |
F.1.1.4 | Infants and toddlers (28 days-23 months) | No | |
F.1.1.5 | Children (2-11years) | No | |
F.1.1.6 | Adolescents (12-17 years) | No | |
F.1.2 | Adults (18-64 years) | No | |
F.1.3 | Elderly (>=65 years) | No | |
F.2 Gender | |||
F.2.1 | Female | Yes | |
F.2.2 | Male | Yes | |
F.3 Group of trial subjects | |||
F.3.1 | Healthy volunteers | No | |
F.3.2 | Patients | Yes | |
F.3.3 | Specific vulnerable populations | Yes | |
F.3.3.1 | Women of childbearing potential not using contraception | No | |
F.3.3.2 | Women of child-bearing potential using contraception | No | |
F.3.3.3 | Pregnant women | No | |
F.3.3.4 | Nursing women | No | |
F.3.3.5 | Emergency situation | No | |
F.3.3.6 | Subjects incapable of giving consent personally | Yes | |
F.3.3.6.1 | Details of subjects incapable of giving consent |
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F.3.3.7 | Others | No | |
F.4 Planned number of subjects to be included | |||
F.4.1 | In the member state | 45 | |
F.4.2 | For a multinational trial | ||
F.4.2.1 | In the EEA | 115 | |
F.4.2.2 | In the whole clinical trial | 115 | |
F.5 | Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition) |
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G. Investigator Networks to be involved in the Trial
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N. Review by the Competent Authority or Ethics Committee in the country concerned
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N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2010-05-28 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
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N. | Date of Ethics Committee Opinion | 2010-05-27 |
P. End of Trial
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P. | End of Trial Status | Prematurely Ended |
P. | Date of the global end of the trial | 2011-03-18 |