An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon *-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combination Study
- Conditions
- hepatitis C10019654viral liver infection10047438
- Registration Number
- NL-OMON39209
- Lead Sponsor
- AbbVie B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
1. Subject must have experienced virologic failure as defined in a previous AbbVie/Abbott DAA
combination trial.
2. Female who is:
* not of childbearing potential, defined as:
* postmenopausal for at least 2 years prior to screening (defined as amenorrheic for longer than 2 years, age appropriate, and confirmed by a follicle-stimulating hormone [FSH] level indicating a postmenopausal state), or
* surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or has a vasectomized partner(s), or
* practicing total abstinence from sexual intercourse (minimum 1 complete menstrual cycle), or
* sexually active with female partners only
* of childbearing potential and sexually active with male partner(s):
* currently using at least one effective method of birth control at the time of screening and agree to practice two effective methods of birth control while receiving study drugs (as outlined in the subject information and consent form or other subject information documents), starting with Study
Day 1 and for 7 months after stopping study drug as directed by the local ribavirin label (Note: Hormonal contraceptives, including oral, topical, injectable or implantable varieties, may not be used during Substudy 1 or for 2 weeks after the last dose of DAA therapy) study drug treatment.
3. Females must have negative results for pregnancy tests performed:
* at Screening by urine specimen within 42 days prior to initial study drug administration, and
* at Baseline (prior to dosing) by urine specimen.
Female subjects with a borderline hCG result at Day 1 may enroll into the study if they either:
* have a documented history of bilateral tubal ligation, hysterectomy, bilateral oophorectomy; or
* are confirmed to be postmenopausal defined as amenorrheic for longer than 2 years, age appropriate, and confirmed by a follicle-stimulating hormone (FSH) level indicating a postmenopausal state at Screening.
4. Sexually active males must be surgically sterile or have male partners only or if sexually active with female partner(s) of childbearing potential must agree to practice two effective forms of birth control (as outlined in the subject information and consent form or other subject information documents) throughout the course of the study, starting with Study Day 1 and for 7 months after stopping study drug or as directed by the local ribavirin label. (Note: Contraceptives containing ethinyl estradiol or depo-progesterone are considered effective if used by the female
partners of male subjects.)
5. For cirrhotic subjects, compensated cirrhosis defined as Child-Pugh score of * 6 at Screening.
6. Subject is infected with HCV genotype 1 at Screening Visit.
1. In subjects with a prior null or partial response to pegIFN/RBV treatment at any time prior to
pre-screening for this study or any prior failure with pegIFN/RBV plus telaprevir, the presence of
variants relative to the appropriate prototypic reference sequence (H77 for 1a or Con1 for 1b) at any of the following amino acid positions: NS3 protease 155, 156, or 168; NS5A 28, 29, 30, 31, 32, 58, or 93.
2. Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of RBV.
3. Use of known strong inhibitors (e.g., ketoconazole) or inducers (e.g., phenobarbital, rifampin,
carbamazepine, St. John's Wort) of CYP3A within 2 weeks prior to study drug administration.
4. Use of any medications contraindicated for use with ABT 450, ABT 267, pegIFN, RBV or ritonavir
within 2 weeks prior to study drug administration.
5. Discontinuation of antiviral therapy due to intolerance or a DAA or RBV associated adverse event in a previous AbbVie/Abbott DAA combination study (excluding intolerance or AEs associated with telaprevir).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy:<br /><br>The primary efficacy endpoint is the percentage of subjects with sustained<br /><br>virologic response 12 weeks after the last actual dose of study drug (including<br /><br>DAA, pegIFN, and RBV) (SVR12actual).<br /><br><br /><br>Safety:<br /><br>Safety and tolerability will be assessed by monitoring adverse events, physical<br /><br>examinations, clinical laboratory tests, 12-lead ECGs and vital signs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary efficacy endpoints are the percentage of subjects with sustained<br /><br>virologic response 24 weeks after the last actual dose of study drug (including<br /><br>DAA, pegIFN, and RBV) (SVR24actual) and the percentage of subjects with eRVR<br /><br>(HCV RNA < LLOQ at Weeks 4 through 12 in Substudy 1).</p><br>