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    Summary
    EudraCT Number:2009-012613-21
    Sponsor's Protocol Code Number:VX-950-TiDP24-C219
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-012613-21
    A.3Full title of the trial
    An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a
    (Pegasys®) and ribavirin (Copegus®) for subjects from the control group of the VX-950-TiDP24-C216
    trial who failed therapy for virologic reasons
    Ensayo de continuación abierto, de un solo grupo, de telaprevir en combinación con interferón pegilado
    alfa-2a (Pegasys®) y ribavirina (Copegus®) realizado con sujetos procedentes del grupo de control del
    ensayo VX-950-TiDP24-C216 con fracaso virológico del tratamiento
    A.4.1Sponsor's protocol code numberVX-950-TiDP24-C219
    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 SponsorTibotec BVBA
    B.1.3.4CountryBelgium
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTelaprevir-tablet-375mg
    D.3.2Product code JNJ-38940655
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtelaprevir
    D.3.9.1CAS number 402957-28-2
    D.3.9.2Current sponsor codeVX-950
    D.3.9.3Other descriptive nameVRT-111950, LY570310, R600109
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.8Extractive medicinal product No
    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 No
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Pegasys®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePeginterferon alpha-2a
    D.3.2Product code LO3A B11
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNPEGINTERFERON ALFA 2A
    D.3.9.1CAS number 198153-51-4
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 No
    D.3.11.8Extractive medicinal product No
    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 No
    D.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Copegus®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRibavirin
    D.3.2Product code JO5A B04
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.8Extractive medicinal product No
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic genotype 1 hepatitis C infection
    hepatitis C crónica genotipo 1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Hepatitis C crónica
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - to provide access to telaprevir for subjects with chronic HCV genotype 1 infection who were randomized to the
    control group in the C216 trial and who failed therapy for virologic reasons;
    - to evaluate efficacy, safety, and tolerability of telaprevir in combination with
    Peg-IFN alfa-2a and RBV in these subjects;
    - to evaluate amino acid changes from baseline in the HCV NS3 protease domain.
    E.2.2Secondary objectives of the trial
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject was randomized to the control group in the C216 trial and failed therapy for virologic reasons.
    The investigator will receive an invitation sent by the unblinded independent virology
    monitor of the C216 trial for those subjects of the C216 trial who were randomized to the control group and who failed therapy for virologic reasons. This invitation should be kept in the subject?s file.
    2. Before entry in the current trial, all assessments in the C216 trial, including the Safety Follow-up Visit, will have to be completed.
    3. Subject is judged to be in good health (besides HCV infection) in the opinion of the
    investigator, on the basis of medical history, physical examination, screening vital signs, screening electrocardiogram [ECG], and screening laboratory tests, with any chronic medical conditions under stable medical control.
    4. If heterosexually active, a female subject of childbearing potential and a non-vasectomized male subject who has a female partner of childbearing potential must agree to the use of 2 effective methods of contraception from screening onwards until 6 months (female subject) or 7 months (male subject) after the last dose of RBV (see also Section 5.2.4).
    Note: Male subjects should use a male condom. This birth control method should be
    combined with another effective method such as hormonal contraceptives (like the patch, or the pill), intrauterine device, diaphragm with spermicidal jelly or cervical cap.
    Note: Hormonal contraceptives may not be reliable when taking telaprevir. Therefore, to be eligible for this trial, subjects should use 2 other effective birth control methods during telaprevir treatment and for 2 months after the last intake of telaprevir. As of 2 months after completion of telaprevir treatment, hormonal contraceptives can again be used as one of the 2 required effective methods of birth control.
    Note: The use of birth control methods does not apply if the male partners have been vasectomized minimally 1 month prior to screening or if the female partners have had a bilateral oophorectomy, a total hysterectomy, or tubal ligation, or if they have been post-menopausal for at least 2 years.
    5. Subject is willing and able to refrain from the concomitant use of any medications,
    substances, or foods noted under the Section 5.3.11, from 14 days prior to the first day of study medication dosing through the end of treatment.
    6. Subject is able to read and understand, and is willing to sign the ICF voluntarily before first trial-related activity and abide by the trial restrictions.
    7. Subjects should agree not to participate in other clinical trials for the duration of his/her participation in this trial, except for non-interventional or observational trials and after prior approval of the sponsor.
    E.4Principal exclusion criteria
    1. Subjects who prematurely discontinued study medication in the C216 trial because of noncompliance (as deemed by the investigator) or for whom repeated treatment would be inappropriate for safety reasons.
    2. Subject received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial.
    3. Subject has developed any new contraindication to the administration of Peg-IFN alfa-2a or RBV since his/her enrollment in the C216 trial, including but not limited to any of the following:
    - hypersensitivity to Peg-IFN alfa-2a, RBV, or any of their components;
    - newly acquired hemoglobinopathies;
    - history or clinical evidence of significant or unstable cardiac disease (e.g. angina,
    congestive heart failure, recent myocardial infarction, significant arrhythmia) and/or
    clinically significant ECG abnormalities;
    - abnormal thyroid function that is not controlled effectively by medication;
    - eye abnormalities at the recommended pretreatment opthalmological clearance;
    - creatinine clearance <=50 mL/min at screening;
    - evidence of autoimmune condition.
    4. Subject has an active of pre-existing psychiatric condition that in the opinion of the
    investigator could interfere with the subject?s participation in and completion of the trial for safety and for other reasons.
    5. Subject has history of decompensated liver disease: history of ascites, hepatic
    encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results:
    - International Normalized Ratio (INR) of >=1.5;
    - Serum albumin < 3.3 g/dL;
    - Serum total bilirubin > 1.8 times upper limit of laboratory normal range (ULN), unless isolated (i.e., only occurring at a single time point and/or not associated with other clinically relevant laboratory abnormalities) or in
    subjects with Gilbert?s Syndrome.
    6. Subject has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
    7. Subject with cirrhosis who has hepatocellular carcinoma. For subjects with cirrhosis, AFP level will be measured and an abdominal ultrasound will be performed in order to screen for hepatocellular carcinoma. In case of AFP > 50 ng/mL or ultrasound being abnormal, subjects must also have a CT or MRI scan to exclude
    hepatocellular carcinoma. Assessments of the AFP level and ultrasounds (and CT or MRI scans if necessary) will be performed at screening, unless these assessments have been performed in the C216 trial within 6 months prior to screening in the current trial.
    8. Subject has history of seizure disorders.
    9. Subject has history of organ transplant that requires chronic immunosuppression (Note: corneal, skin, and hair grafts are allowed).
    10. Subject has a medical condition that requires use of systemic corticosteroids (e.g., severe asthma, severe arthritis, or autoimmune conditions, organ transplantation, adrenal insufficiency, etc.)
    11. Diabetic or hypertensive subject with clinically significant ocular exam findings, e.g., retinopathy, cotton wool spots, and optic nerve disorder. Clearance by an ophthalmologist is required within 3 months prior to screening or within the screening period. The ophthalmologist should conduct a fundoscopic exam, which should be documented in the subjects? records. The findings of the exam must also be recorded on the eCRF.
    12. Subject has evidence of serious or severe bacterial or fungal infection(s), including active tuberculosis.
    13. Subject has HIV or hepatitis B virus (HBV) co-infection.
    14. Subject has a history of acute or chronic pancreatitis.
    15. Suspicion exists of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, current or within 2 years prior to the screening visit, that in the investigator?s opinion would compromise the subject?s safety and/or
    compliance with study procedures.
    16. Subject or female partner is pregnant or planning to become pregnant.
    17. Subject is breastfeeding.
    18. Subject has any clinically significant laboratory abnormalities as judged by the investigator, with the following exceptions:
    - Grade 3 elevations in transaminsases ([ALT], [AST]). However, ALT/AST levels at screening should not exceed 10 times ULN.
    - Grade 3 elevations in GGT. However, subjects with grade 3 GGT elevations will only be allowed to enter the trial if there is no evidence of current alcohol abuse and if the GGT elevations are not associated with other clinically relevant laboratory abnormalities, as judged by the investigator. OR Subject has screening laboratory values of the following variables that do not meet the acceptable values defined
    below:
    Absolute neutrophil count ? 1,200/mm3, Platelet count ? 90,000/mm3, Hemoglobin ? 12 g/dL for females ? 13 g/dL for males, Thyroid-stimulating hormone (TSH) Within normal range, or adequately controlled thyroid function on treatment
    E.5 End points
    E.5.1Primary end point(s)
    plasma HCV RNA quantification
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 120
    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 Decision2010-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-16
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