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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01609933
First received: May 30, 2012
Last updated: March 15, 2013
Last verified: March 2013
  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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609933

  Show 29 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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