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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01767116
First received: November 30, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

A study to evaluate chronic hepatitis C infection in adults with genotype 1b 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-Naive Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)

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 last 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:
  • Percentage of subjects with end of treatment response [ Time Frame: During treatment (up to 12 weeks) ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification at week 12

  • Percentage of subjects with a decrease in hemoglobin to below the lower limit of normal while on treatment between treatment arms [ Time Frame: During treatment (up to 12 weeks) ] [ Designated as safety issue: Yes ]
    Comparison of hemoglobin, less than or equal to the lower limit of normal, at the end of treatment visit for subjects in both treatment arms

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


Estimated Enrollment: 400
Study Start Date: December 2012
Estimated Study Completion Date: August 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
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
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 1b-infected treatment-naive adults (PEARL-III).

  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 1b infection (HCV RNA level greater than 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
  • Significant sensitivity to any drug
  • Use of contraindicated medications within 2 weeks of dosing
  • Infection with any other genotype or subtype of hepatitis C
  • 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: NCT01767116

  Show 51 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Dan Cohen, 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 ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01767116     History of Changes
Other Study ID Numbers: M13-961, 2012-003687-52
Study First Received: November 30, 2012
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Austria: Federal Office for Safety in Health Care
Israel: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Portugal: Ethics Committee for Clinical Research
Hungary: Scientific and Medical Research Council Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Poland: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Portugal: National Pharmacy and Medicines Institute
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Romania: Ethics Committee
Israel: Ethics Commission
Austria: Agency for Health and Food Safety
Belgium: Ethics Committee
Romania: National Agency for Medicines and Medical Devices

Keywords provided by AbbVie:
Interferon-Free
Hepatitis C Genotype 1b
Chronic Hepatitis C
Hepatitis C Virus
Hepatitis C
Treatment-Naive

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 July 22, 2014