Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2004-000438-35
    Sponsor's Protocol Code Number:CL 0600-004
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-08-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2004-000438-35
    A.3Full title of the trial
    A study of the Efficacy and Safety of Teduglutide in subjects with Parenteral Nutritional Dependant Short Bowel Syndrome
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberCL 0600-004
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNPS Allelix Corporation
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/01/077
    D.3 Description of the IMP
    D.3.1Product nameTeduglutide
    D.3.2Product code ALX - 0600
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeALX - 0600
    D.3.9.3Other descriptive nameRecombinant glycine2-human glucagon-like peptide-2, rh (gly2) GLP-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 mg/0.5 ml to 10mg/0.5ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeTeduglutide is a recombinant analogue of the human intestinal peptide glucagon-like peptide-2 (GLP-2) extracted from E.Coli.
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Short Bowel Syndrome (SBS) refers to the clinical situation whereby a significant reduction in the absorptive capacity of the intestine results from inadequate anatomical or functional length of residual small intestine following surgical resection. These patients are highly prone to malnutrition, diarrhea, and dehydration due to the reduced intestinal capacity to absorb macronutrients, water and electrolytes (1-8).
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this clinical study is to evaluate the efficacy, safety, tolerability, and
    pharmacokinetics (PK) of teduglutide compared with placebo in subjects with
    PN (Parenteral Nutrition)-dependent SBS.
    The primary objective is to compare the percentage of subjects treated with teduglutide versus placebo who demonstrate a response at week 20, and who maintain that response through week 24. A response in this study is defined as the achievement of at least a 20% reduction from baseline in weekly PN volume.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives are to evaluate changes in volume of PN, frequency of PN, frequency of iv catheter access, and to evaluate quality of life and utilization of healthcare resources.
    Additional variables to be evaluated are changes from baseline in parathyroid hormone (PTH), bone markers, bone mineral density (BMD), plasma citrulline, and intestinal mucosal villus height and crypt depth. At selected centers, additional objectives are to evaluate changes in the enteral absorption of gastrointestinal fluid (wet weight), calories, nitrogen, fat, carbohydrate, sodium, magnesium, calcium, and potassium.
    The safety and tolerability of teduglutide treatments compared with placebo will be
    assessed. The population PK of teduglutide in subjects with PN-dependent SBS will also be determined.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria can be enrolled in this study:
    1.Signed and dated informed consent form (ICF) before any study-related procedures are performed
    2.Men and women, aged 18 years of age or older at the time of signing the ICF
    3.SBS as a result of major in testinal resection, e.g., due to injury, volvulus, vascular disease, cancer, Crohn’s disease
    a.For subjects with a history of cancer (there are exceptions listed in Sec. 4.3 Exclusion criteria), the subject should be disease-free for at least 5 years
    b.For subjects with a history of Crohn’s disease, the subject should be in clinical remission, as determined by clinical assessment
    4.Body weight must be less than 90 kg at the time of enrollment
    5.Major intestinal resection resulting in at least 12 months dependency prior PN to the date of the signature of ICF. Minor ostomy revisions within this time period are allowable
    6.At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly
    7.Stable for at least 4 consecutive weeks just prior to randomization in:
    a. Usage and volume of PN
    b. 48-hour urinary output (1.0 to 2.0 L/d)
    c. Urine sodium (greater than 20 mmol/d)
    d. Adequate renal function (serum creatinine and blood urea nitrogen [BUN]1.5 x ULN or less)
    e. Hct indicating satisfactory hydration (ULN or less)
    f. Motility altering medications (as defined in the Section 5.4)
    8.Body mass index (BMI) 18 to 27 kg/m2
    9.Adequate hepatic function: (Alanine aminotransferase [ALT] and aspartate aminotransferase [AST] both less than 2. 0 x ULN; total bilirubin less than 1.25 x ULN; and alkaline phosphatase less than 2.5 x ULN)
    10.Female subjects who are not surgically sterile or postmenopausal must use 30 days after medically acceptable methods of birth control during and for the treatment period (see Section 6.2.7). Postmenopausal is defined as aged 60 years or older and 2 years must have elapsed since the last menses.
    11.Capable of understanding and be willing to adhere to the study visit schedule and other protocol requirements.
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will be excluded:
    1.History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state. This does not include resected cutaneous basal or squamous cell carcinoma, or in situ cervical cancer.
    2.History of alcohol or drug abuse (within previous year)
    3.Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study
    4.Clinically significant laboratory abnormalities at the time of randomization
    5.Previous use of teduglutide (ALX-0600)
    6.Prior use of native GLP-2 within 3 months of screening visit
    7.Hospital admission within 1 month prior to screening visit
    8.Pregnant or lactating women
    9.Any condition or circumstance, which in the investigator’s opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results
    10.Presence of excluded disease. The following is a table of excluded disease states arranged by body systems:
    Related to SBS
    Radiation enteritis
    Scleroderma
    Celiac disease
    Refractory or tropical sprue
    Pseudo-obstruction

    Gastrointestinal (GI)
    Active inflammatory bowel disease (IBD)
    Pre-malignant or malignant change in colonoscopy biopsy or polypectomy
    Surgery scheduled within the time frame of the study

    Immune
    Human immunodeficiency virus (HIV) positive test
    Immunological disorders
    Possible allergies to teduglutide or its constituents

    Cardiovascular, respiratory, renal, endocrine, hepatic, or CNS
    Significant active, uncontrolled, untreated systemic diseases

    11. Failure to adhere to required washout periods. The following table contains lists of certain medications, arranged by the periods of time that must have transpired after stopping them before the first dose of teduglutide in this study. Use of iv insulin is not excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the percentage of subjects who demonstrate a
    response at week 20, and who maintain that response through week 24. A response in this study is defined as the achievement of at least a 20% reduction from baseline in weekly PN volume.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    There will be a 4-week follow-up period for subjects not entering into the extension study, during which subjects will not dose with study drug. The final study visit for these subjects will occur at the end of this 4-week period (week 28). The end of the study is defined as the day the last subject completes the last day of follow-up (week 28) or enters protocol CL0600-005.

    All subjects who discontinue the study prematurely will be required to perform applicable week 24 evaluations.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-08-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 125
    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)
    Details provided in protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-06
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 14:08:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA