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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01833533
First received: February 27, 2013
Last updated: September 16, 2014
Last verified: September 2014

February 27, 2013
September 16, 2014
March 2013
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01833533 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
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)

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

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Hepatitis C Infection
  • Drug: ABT-450/r/ABT-267
    Tablet
  • Drug: ABT-333
    Tablet
  • Drug: Ribavirin
    Tablet
  • Drug: Placebo for Ribavirin
    Tablet
  • 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
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin
  • 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
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Placebo for Ribavirin
Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014 May 22;370(21):1983-92. doi: 10.1056/NEJMoa1402338. Epub 2014 May 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
305
September 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   United Kingdom
 
NCT01833533
M14-002, 2012-005522-29
Yes
AbbVie
AbbVie
Not Provided
Study Director: Yan Luo, MD AbbVie
AbbVie
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP