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: December 23, 2014
Last verified: December 2014

February 27, 2013
December 23, 2014
March 2013
December 2013   (final data collection date for primary outcome measure)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.

The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV.

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
Complete list of historical versions of study NCT01833533 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment [ Time Frame: Baseline (Day 1) and Week 12 (End of Treatment) ] [ Designated as safety issue: Yes ]
    The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.
  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]

    The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

    The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.

  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12 ] [ Designated as safety issue: No ]
    Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
  • Percentage of Participants With Virologic Relapse After Treatment [ Time Frame: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment) ] [ Designated as safety issue: No ]
    Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.
  • 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
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)

The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.

A randomized, double-blind, placebo-controlled, 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 (RBV) in treatment-naive, noncirrhotic participants with chronic hepatitis C virus genotype 1a (HCV GT1a) infection. Safety and efficacy data through 12 December 2013 are included in the interim analysis, which was conducted after all participants completed the post-treatment week 12 visit or discontinued from the study.

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; ABT-450 coformulated with ritonavir and ABT-267
    Other Name: ABT-267 also known as ombitasvir
  • Drug: ABT-333
    Tablet
    Other Name: dasabuvir
  • Drug: Ribavirin
    Capsule
  • Drug: Placebo for ribavirin
    Capsule
  • Experimental: 450/r/ABT-267 and ABT-333, Plus RBV
    ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin
  • Experimental: ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) 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; PEARL-III Study; PEARL-IV Study. 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 practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
  • 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:

  • Significant liver disease with any cause other than HCV as the primary cause
  • Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody
  • Positive screen for drugs or alcohol
  • Significant sensitivity to any drug
  • Use of contraindicated medications within 2 weeks of dosing
  • Abnormal laboratory tests
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, PhD AbbVie
AbbVie
December 2014

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