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
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Hepatitis C Virus (HCV)
Drug: ABT-267
Drug: Peginterferon alpha-2a (pegIFN)
Drug: Ribavirin (RBV)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 37
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Low dose ABT-267 + Peginterferon alpha-2a/Ribavirin (pegIFN/RBV)
Drug: ABT-267
tablet
Drug: Peginterferon alpha-2a (pegIFN)
injectible solution
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 2
Medium dose ABT-267 + pegIFN/RBV
Drug: ABT-267
tablet
Drug: Peginterferon alpha-2a (pegIFN)
injectible solution
Drug: Ribavirin (RBV)
tablet
Experimental: Arm 3
High dose ABT-267 + pegIFN/RBV
Drug: ABT-267
tablet
Drug: Peginterferon alpha-2a (pegIFN)
injectible solution
Drug: Ribavirin (RBV)
tablet
Placebo Comparator: Arm 4
Placebo + pegIFN/RBV
Drug: Peginterferon alpha-2a (pegIFN)
injectible solution
Drug: Ribavirin (RBV)
tablet
Drug: Placebo
tablet

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314261

Locations
United States, Alabama
Site Reference ID/Investigator# 56623
Birmingham, Alabama, United States, 35215
United States, California
Site Reference ID/Investigator# 48476
Los Angeles, California, United States, 90048
United States, Florida
Site Reference ID/Investigator# 51345
Orlando, Florida, United States, 32809
United States, Hawaii
Site Reference ID/Investigator# 51498
Honolulu, Hawaii, United States, 96814
United States, Indiana
Site Reference ID/Investigator# 48473
Indianapolis, Indiana, United States, 46202
United States, Missouri
Site Reference ID/Investigator# 52782
Kansas City, Missouri, United States, 64134
United States, Texas
Site Reference ID/Investigator# 48471
Houston, Texas, United States, 77030
Site Reference ID/Investigator# 48474
San Antonio, Texas, United States, 78215
United States, Virginia
Site Reference ID/Investigator# 48477
Fairfax, Virginia, United States, 22031
United States, Washington
Site Reference ID/Investigator# 48472
Seattle, Washington, United States, 98101
Puerto Rico
Site Reference ID/Investigator# 48483
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Armen Asatryan, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01314261     History of Changes
Other Study ID Numbers: M12-114
Study First Received: March 11, 2011
Last Updated: March 8, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014