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Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01314261
First received: March 11, 2011
Last updated: March 8, 2013
Last verified: March 2013

March 11, 2011
March 8, 2013
March 2011
January 2012   (final data collection date for primary outcome measure)
Assess 4-week rapid virologic response (RVR) [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
Assess 4-week rapid virologic response (RVR) of three different doses of ABT-267 in combination with pegIFN/RBV compared to pegIFN/RBV alone (ABT-267 placebo) in HCV genotype 1-infected treatment-naive adults.
Assess 4-week rapid virologic response (RVR) [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01314261 on ClinicalTrials.gov Archive Site
  • Assess percentage of subjects with partial early virologic response (EVR). [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Assess the percentage of subjects with partial virologic response (EVR).
  • Assess percentage of subjects with complete early virologic response (cEVR). [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
    Assess percentage of subjects with complete early virologic response (cEVR).
  • Assess percentage of subjects with partial early virologic response (EVR). [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Assess percentage of subjects with complete early virologic response (cEVR). [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
A Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABT-267 in combination with Peginterferon alpha-2a/Ribavirin (pegIFN/RBV) for 12 weeks in treatment naïve Hepatitis C virus (HCV) genotype 1 infected subjects.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Hepatitis C
  • Hepatitis C Virus (HCV)
  • Drug: ABT-267
    tablet
  • Drug: Peginterferon alpha-2a (pegIFN)
    injectible solution
  • Drug: Ribavirin (RBV)
    tablet
  • Drug: Placebo
    tablet
  • Experimental: Arm 1
    Low dose ABT-267 + Peginterferon alpha-2a/Ribavirin (pegIFN/RBV)
    Interventions:
    • Drug: ABT-267
    • Drug: Peginterferon alpha-2a (pegIFN)
    • Drug: Ribavirin (RBV)
  • Experimental: Arm 2
    Medium dose ABT-267 + pegIFN/RBV
    Interventions:
    • Drug: ABT-267
    • Drug: Peginterferon alpha-2a (pegIFN)
    • Drug: Ribavirin (RBV)
  • Experimental: Arm 3
    High dose ABT-267 + pegIFN/RBV
    Interventions:
    • Drug: ABT-267
    • Drug: Peginterferon alpha-2a (pegIFN)
    • Drug: Ribavirin (RBV)
  • Placebo Comparator: Arm 4
    Placebo + pegIFN/RBV
    Interventions:
    • Drug: Peginterferon alpha-2a (pegIFN)
    • Drug: Ribavirin (RBV)
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
February 2013
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, 18-65 years old, inclusive.
  • Treatment naïve.
  • Females must be either postmenopausal for at least 2 years or surgically sterile and males must be surgically sterile or practicing specific forms of birth control.
  • Chronic hepatitis C virus (HCV) genotype-1 infection.
  • Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis.

Exclusion Criteria:

  • Pregnant or breastfeeding female.
  • Use of any medications contraindicated for use with Peginterferon alpha-2a (pegIFN) or Ribavirin (RBV) within 2 weeks prior to study drug administration.
  • Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, or neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder.
  • Current or past clinical evidence of cirrhosis or bridging fibrosis.
  • Abnormal screening laboratory results.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01314261
M12-114
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Armen Asatryan, MD AbbVie
AbbVie
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP