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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)

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ClinicalTrials.gov Identifier: NCT02707952
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic hepatitis C virus infection.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus Hepatitis C Virus Drug: ABT-493/ABT-530 Drug: Ombitasvir/paritaprevir/ritonavir Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)
Study Start Date : February 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ABT-493/ABT-530, GT1 (8 wks)
ABT-493/ABT-530 in HCV GT1 infected participants for 8 weeks
Drug: ABT-493/ABT-530
Tablet
Other Name: Glecaprevir/Pibrentasvir
Experimental: Ombitasvir/paritaprevir/ritonavir
Ombitasvir/paritaprevir/ritonavir in HCV GT1 infected participants for 12 weeks
Drug: Ombitasvir/paritaprevir/ritonavir
Tablet
Experimental: ABT-493/ABT-530, GT1 through GT6 infected (12 wks)
ABT-493/ABT-530, in HCV GT1-GT6 infected participants for 12 weeks
Drug: ABT-493/ABT-530
Tablet
Other Name: Glecaprevir/Pibrentasvir
Experimental: ABT-493/ABT-530, renal impaired (8 wks)
ABT-493/ABT-530 in renal impaired participants for 8 weeks
Drug: ABT-493/ABT-530
Tablet
Other Name: Glecaprevir/Pibrentasvir



Primary Outcome Measures :
  1. Percentage of participants who achieve 12-week sustained virologic response (SVR12) [ Time Frame: Up to 12 weeks after last dose of study drug ]
    Hepatitis C virus ribonucleic acid level less than the lower limit of quantification


Secondary Outcome Measures :
  1. Percentage of participants treated with ABT-493/ABT-530 who achieve 12-week sustained virologic response (SVR12) [ Time Frame: Up to 12 weeks after the last dose of study drug ]
  2. Percentage of participants who achieve 12-week sustained virologic response (SVR12) for each sub-population [ Time Frame: Up to 12 weeks after last dose of study drug ]
    Subpopulations defined as Genotype 1 and 2 infected cirrhotic participants, prior direct acting antiviral agent (DAA) experienced participants, Genotype 3, 4, 5 or 6-infected participants, and participants with severe renal impairment

  3. Percentage of participants with virologic failure during treatment [ Time Frame: Up to last dose of study drug, minimally week 8 ]
    Confirmed quantifiable hepatitis C virus ribonucleic acid among participants with previously unquantifiable hepatitis C virus ribonucleic acid during treatment

  4. Percentage of participants with Post-Treatment relapse [ Time Frame: Within 12 weeks after the last dose of study drug ]
    Percentage of participants with confirmed quantifiable hepatitis C virus ribonucleic acid after completion of treatment among participants with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Screening central laboratory result indicating HCV single genotype infection for the appropriate treatment arm, without co-infection of any other genotype.
  • Chronic HCV infection defined as one of the following:

    • Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before Screening.
    • A liver biopsy consistent with chronic HCV infection.
  • Must voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study specific procedures.
  • Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
  • Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

  • Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti human immunodeficiency virus antibody (HIV Ab).
  • Receipt of any investigational product within a time period equal to 10 half‑lives of the product, if known, or a minimum of 6 weeks (whichever is longer) prior to study drug administration.
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707952


  Show 62 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Koji Kato, MD AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02707952     History of Changes
Other Study ID Numbers: M15-594
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by AbbVie:
Compensated cirrhosis
Hepatitis C Genotype 1
Hepatitis C Genotype 5
Non-cirrhotic
Hepatitis C virus
Hepatitis C Genotype 6
Hepatitis C Genotype 3
Hepatitis C Genotype 4
Renal impairment
Hepatitis C Genotype 2
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Virus Diseases
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors