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 AbbVie/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: July 21, 2014
Last verified: July 2014
  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 AbbVie/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 α-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

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: 93
Study Start Date: December 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 or tablets)
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 AbbVie/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 AbbVie/Abbott direct acting anti-viral combination trial.
  • Female subjects of childbearing potential and sexually active with male partner(s) must be willing to use two effective forms of birth control while receiving study drug and for 7 months (or per local ribavirin label) after stopping study drug (as outlined in the subject information and consent form or other subject information documents). (Note: Hormonal contraceptives, including oral, topical, injectable or implantable varieties, may not be used during Substudy 1 or for 2 weeks after last dose of DAA therapy).
  • Males must be surgically sterile or have male partners only or agree to practice two effective forms of birth control throughout the course of the study, starting with Study Day 1 and for 7 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.

Subjects diagnosed with cirrhosis must also meet the following criteria:

  • Compensated cirrhosis defined as Child-Pugh score of ≤ 6 at Screening.
  • Absence of hepatocellular carcinoma based on a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) performed within 3 months prior to Screening or during the Screening period.

Exclusion Criteria:

  • 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 positions: NS3 155, 156, or 168; or 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 within 7 months (or per local RBV label) after their last dose of RBV.
  • 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.
  • Use of any medications contraindicated for use with peginterferon alpha-2a, RBV or ritonavir within 2 weeks prior to study drug administration. 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 DAA- or RBV-associated adverse event in a previous AbbVie/Abbott DAA combination study.

Subjects with compensated cirrhosis must also not meet the following criteria:

  • Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
  • Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.
  • A screening ultrasound suspicious for hepatocellular carcinoma and confirmed with a subsequent CT scan or MRI during the screening period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 93 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: July 21, 2014
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
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
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 July 24, 2014