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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01609933
First received: May 30, 2012
Last updated: January 6, 2017
Last verified: January 2017
  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: 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 ]
    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 ]
    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 ]
    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) ]
    Assess the safety of the treatment regimen


Estimated Enrollment: 35
Study Start Date: December 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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 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 7 months (or per local ribavirin label) after stopping study drug
  • 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 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 43 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Mariem Charafeddine, MD AbbVie
  More Information

Responsible Party: 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: January 6, 2017

Keywords provided by AbbVie:
Hepatitis C
Hepatitis C Genotype 1
Chronic Hepatitis C
HCV

Additional relevant MeSH terms:
Hepatitis C
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
Interferon-alpha
Peginterferon alfa-2a
Antiviral Agents
Interferons
Ribavirin
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 17, 2017