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
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: NCT01833533

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

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014