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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01674725
First received: July 27, 2012
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

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 1b (HCV GT1b) infection without cirrhosis.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: ABT-450/r/ABT-267
Drug: ABT-333
Drug: Ribavirin
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 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 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV.



Secondary Outcome Measures:
  • 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 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 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 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b 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 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 was calculated using the Wilson score method because the point estimate was 0%.


Enrollment: 187
Study Start Date: August 2012
Study Completion Date: October 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-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
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
Tablet
Experimental: ABT-450/r/ABT-267 and ABT-333
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
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

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 (RBV) in treatment-experienced, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection. Safety and efficacy data through 16 January 2014 are included in the interim analysis, which was conducted after all participants completed the post-treatment week 12 visit or discontinued from the study.

  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 practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
  • Subject failed previous treatment with pegylated interferon and ribavirin
  • Chronic hepatitis C virus genotype 1b-infection for at least 6 months prior to study Screening
  • Subject's hepatitis C virus genotype is subgenotype 1b at Screening without co-infection with any other genotype/subgenotype.

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
  • Use of contraindicated medications within 2 weeks of dosing
  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

Additional 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
Results First Received: December 23, 2014
Last Updated: December 23, 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
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Ribavirin
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015