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A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in People With Chronic Hepatitis C (PEARL-II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01674725
First received: July 27, 2012
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

A study to assess the safety and effect of the experimental drugs ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in people with chronic hepatitis C.


Condition Intervention Phase
Hepatitis C
Drug: ABT-450/r/ABT-267
Drug: ABT-333
Drug: Ribavirin (RBV)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-II)

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 last actual dose of 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: During treatment (from baseline 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: During treatment (up to 12 weeks) ] [ 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: After last dose until 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid greater than the lower limit of quantification


Estimated Enrollment: 210
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-450/r/ABT-267, ABT-333, RBV dosed in combination
ABT-450/r/ABT-267, ABT-333, RBV dosed in combination
Drug: ABT-450/r/ABT-267
ABT-450/ritonavir/ABT-267 (tablets)
Drug: ABT-333
ABT-333 (tablets)
Drug: Ribavirin (RBV)
Ribavirin (tablets)
Experimental: ABT-450/r/ABT-267, ABT-333 dosed in combination
ABT-450/r/ABT-267, ABT-333 dosed in combination
Drug: ABT-450/r/ABT-267
ABT-450/ritonavir/ABT-267 (tablets)
Drug: ABT-333
ABT-333 (tablets)

Detailed Description:

A randomized, open-label, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin in treatment-experienced subjects with genotype 1b chronic hepatitis C virus (HCV) infection (PEARL-II).

  Eligibility

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

Inclusion Criteria:

  1. Subject failed previous treatment with pegylated interferon and ribavirin
  2. Chronic Hepatitis C Virus genotype 1b-infection for at least 6 months prior to study Screening
  3. Subject's Hepatitis C Virus genotype is subgenotype 1b at Screening without co infection with any other genotype/subgenotype.

Exclusion Criteria:

  1. Recent history of drug or alcohol abuse
  2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-HIV antibodies (anti-HIV Ab)
  3. Any current or past clinical evidence of cirrhosis
  4. Any cause of liver disease other than chronic HCV infection.
  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: NCT01674725

  Show 49 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jeffrey Enejosa, 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: NCT01674725     History of Changes
Other Study ID Numbers: M13-389, 2011-005740-95
Study First Received: July 27, 2012
Last Updated: September 16, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
United States: Food and Drug Administration
Switzerland: Swissmedic
Turkey: Ministry of Health
Portugal: National Pharmacy and Medicines Institute

Keywords provided by AbbVie:
Hepatitis C virus
Hepatitis C Genotype 1
Hepatitis C
Interferon-Free
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on September 22, 2014