A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection (PEARL-IV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01833533
First received: February 27, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

This is a study to evaluate chronic hepatitis C infection in adults with genotype 1a infection.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: ABT-450/r/ABT-267
Drug: ABT-333
Drug: Ribavirin
Drug: Placebo for Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) INfection (PEARL-IV)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of subjects in each treatment group with sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after the actual dose of active study drug ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification


Secondary Outcome Measures:
  • Changes in hemoglobin laboratory values during treatment [ Time Frame: Day 1 through Week 12 ] [ Designated as safety issue: Yes ]
    Hemoglobin laboratory values below the the lower limit of normal

  • Percentage of subjects with virologic failure during treatment [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid greater than the lower limit of quantification

  • Percentage of subjects with virologic relapse after treatment [ Time Frame: Up to post-treatment Week 48 ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid greater than the lower limit of quantification


Estimated Enrollment: 300
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (DAA + RBV)
ABT-450/r/ABT-267 150 mg/100 mg/ 25 mg once a day + ABT-333 250 mg twice a day + ribavirin twice a day for 12 weeks
Drug: ABT-450/r/ABT-267
Tablet
Drug: ABT-333
Tablet
Drug: Ribavirin
Tablet
Experimental: Arm B (DAA + placebo for RBV)
ABT-450/r/ABT-267 150 mg/100 mg/ 25 mg once a day + ABT-333 250 mg twice a day + placebo for ribavirin twice a day for 12 weeks
Drug: ABT-450/r/ABT-267
Tablet
Drug: ABT-333
Tablet
Drug: Placebo for Ribavirin
Tablet

Detailed Description:

The purpose of this study is to evaluate the safety and effect of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin in hepatitis C virus genotype 1a-infected treatment-naïve adults (PEARL-IV).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
  • Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
  • Subject has never received antiviral treatment for hepatitis C infection
  • No evidence of liver cirrhosis

Exclusion Criteria:

  • Positive screen for drugs or alcohol
  • Significant sensitivity to any drug
  • Use of contraindicated medications within 2 weeks of dosing
  • Abnormal laboratory tests
  • Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01833533

  Show 54 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Yan Luo, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01833533     History of Changes
Other Study ID Numbers: M14-002, 2012-005522-29
Study First Received: February 27, 2013
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AbbVie:
Chronic Hepatitis C
Hepatitis C Virus
Hepatitis C Genotype 1a
Hepatitis C
Treatment-Naïve
Interferon-Free

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
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014