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
- Conditions
- chronic genotype 1 hepatitis C infectionMedDRA version: 12.0Level: LLTClassification code 10008912Term: Chronic hepatitis C
- Registration Number
- EUCTR2009-012613-21-NL
- Lead Sponsor
- Tibotec BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 v
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - 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;<br>- to evaluate efficacy, safety, and tolerability of telaprevir in combination with<br>Peg-IFN alfa-2a and RBV in these subjects;<br>- to evaluate amino acid changes from baseline in the HCV NS3 protease domain.;Secondary Objective: ;Primary end point(s): plasma HIV RNA quantification
- Secondary Outcome Measures
Name Time Method