A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous Abbott Combination Study
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Purpose
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who did not respond to treatment in a previous Abbott combination study.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 1 |
Drug: ABT-450/r Drug: ABT-267 Drug: pegylated interferon alpha-2a (pegIFN) Drug: Ribavirin (RBV) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct Acting Antiviral Agent (DAA) Treatment in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous Abbott DAA Combination Study |
- Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals and peginterferon alpha-2a and ribavirin in Hepatitis C infected adults. [ Time Frame: Post Treatment Week 12 ] [ Designated as safety issue: No ]Assess the percentage of subjects achieving 12-week sustained virologic response (Hepatitis C ribonucleic acid less than lower limit of quantitation at post-treatment Week 12) following treatment with 2 direct acting anti-virals (ABT-450/r, ABT-267) and peginterferon alpha-2a and ribavirin in Hepatitis C infected adults
- Percentage of subjects achieving 24-week sustained virologic response following treatment with 2 direct acting anti-viral and peginterferon alpha-2a and ribavirin in Hepatitis C infected adults. [ Time Frame: Post Treatment Week 24 ] [ Designated as safety issue: No ]Assess the percentage of subjects achieving 24-week sustained virologic response (Hepatitis C ribonucleic acid less than lower limit of quantitation at post-treatment Week 24) following treatment with 2 direct acting anti-virals (ABT-450/r, ABT-267) and peginterferon alpha-2a and ribavirin in Hepatitis C infected adults
- Percentage of subjects with extended rapid virologic response (Hepatitis C ribonucleic acid less than lower limit of quantitation at Weeks 4 through 12 of therapy with ABT 450/r plus ABT-267 plus peginterferon alpha-2a plus ribavirin) [ Time Frame: Weeks 4 - 12 ] [ Designated as safety issue: No ]Percentage of subjects with extended rapid virologic response (Hepatitis C ribonucleic acid less than lower limit of quantitation at Weeks 4 through 12 of therapy with ABT 450/r plus ABT-267 plus and peginterferon alpha-2a plus ribavirin
- Number and percentage of subjects having treatment-emergent adverse events. [ Time Frame: Baseline to 30 days after the end of active treatment (up to 48 weeks) ] [ Designated as safety issue: Yes ]Assess the safety of the treatment regimen
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
ABT-450/r, ABT-267, pegylated interferon alpha-2a (pegIFN) and Ribavirin (RBV) in combination
|
Drug: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules)
Drug: ABT-267
ABT-267 (tablets)
Drug: pegylated interferon alpha-2a (pegIFN)
pegylated interferon alpha-2a syringe
Drug: Ribavirin (RBV)
Ribavirin (tablets)
|
Detailed Description:
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who did not respond to treatment in a previous Abbott combination study. The study will test the safety and effects of this alternative treatment for up to 48 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 71 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Main Inclusion: To be enrolled in this protocol, subjects must meet all of the following inclusion criteria:
- Subject must have experienced virologic failure as defined in a previous peginterferon alpha-2a-free Abbott direct acting anti-viral combination trial.
- Female subjects of childbearing potential must be willing to use two effective forms of birth control (not including oral contraceptives or contraceptives containing ethinyl estradiol) while receiving study drug and for 6 months (or per local ribavirin label) after stopping study drug, unless abstinent from sexual intercourse.
- Males must be surgically sterile or agree to practice two effective forms of birth control throughout the course of the study, starting with Study Day 1 and for 6 months (or per local ribavirin label) after the last dose of study drug, unless abstinent from sexual intercourse.
- Subject must be considered an appropriate candidate for peginterferon alpha-2a, ribavirin, ABT-450/r and ABT-267 therapy in the opinion of the investigator.
- Subject is infected with HCV genotype 1 at screening.
Exclusion Criteria:
- In subjects with a null or partial response to peginterferon alpha-2a/ribavirin treatment (at the time of enrollment into the previous Abbott direct acting antiviral combination study), 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.
- Females who are pregnant or plan to become pregnant, or breast-feeding, or males whose partners are pregnant or planning to become pregnant.
- Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., phenobarbital, rifampin, carbamazepine, St. John's Wort) of CYP3A and OATP1B1 (e.g., cyclosporine) within 1 month prior to study drug administration.
- Use of any medications contraindicated for use with peginterferon alpha-2a, ribavirin or ritonavir within 2 weeks prior to study drug administration or 10 half-lives, whichever is longer. Prior to entering the study, subjects must be able to safely discontinue the contraindicated medication or switch to an acceptable alternative under supervision of the investigator.
- Discontinuation of antiviral therapy due to intolerance or a direct acting antiviral or ribavirin associated adverse event in a previous Abbott direct acting anti-viral combination study.
Contacts and Locations
Show 29 Study Locations| Study Director: | Daniel Cohen, MD | AbbVie |
More Information
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01609933 History of Changes |
| Other Study ID Numbers: | M13-101, 2011-005393-32 |
| Study First Received: | May 30, 2012 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada New Zealand: Medsafe Australia: Department of Health and Ageing Therapeutic Goods Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Hungary: National Institute of Pharmacy Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Ministry of Health Romania: National Medicines Agency Sweden: Medical Products Agency Turkey: Ministry of Health Switzerland: Swissmedic Finland: Ministry of Social Affairs and Health Russia: Ministry of Health of the Russian Federation Czech Republic: State Institute for Drug Control Hungary: Scientific and Medical Research Council Ethics Committee France: Ministry of Health Brazil: Ministry of Health Portugal: National Pharmacy and Medicines Institute Norway: Norwegian Medicines Agency Slovenia: Agency for Medicinal Products - Ministry of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Mexico: National Council of Science and Technology Belgium: Ministry of Social Affairs, Public Health and the Environment Chile: Ministry of Health Ireland: Ministry of Health |
Keywords provided by AbbVie:
|
Hepatitis C Genotype 1 Hepatitis C HCV Chronic Hepatitis C |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a |
Antiviral Agents Interferons Ribavirin Peginterferon alfa-2a Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites |
ClinicalTrials.gov processed this record on June 17, 2013