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A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection

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ClinicalTrials.gov Identifier: NCT02356562
Recruitment Status : Completed
First Posted : February 5, 2015
Results First Posted : November 24, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.

Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.

Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.


Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir Drug: Sofosbuvir Drug: Ribavirin Phase 2

Detailed Description:
Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With or Without Sofosbuvir (SOF) and Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Actual Study Start Date : February 3, 2015
Actual Primary Completion Date : October 28, 2016
Actual Study Completion Date : July 7, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3-DAA with or without SOF and RBV
3-DAA (ombitasvir/paritaprevir/ritonavir once daily [QD] and dasabuvir twice daily [BID]) with and without sofosbuvir (SOF) QD and with or without ribavirin (RBV) BID for 12 or 24 weeks
Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir
tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir
Other Names:
  • ABT-450/r/ABT-267
  • Viekira Pak
  • paritaprevir also known as ABT-450
  • ombitasvir also known as ABT-267
  • dasabuvir also known as ABT-333

Drug: Sofosbuvir
tablet
Other Name: Sovaldi

Drug: Ribavirin
tablet
Other Name: RBV




Primary Outcome Measures :
  1. Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment [ Time Frame: 12 weeks after the last dose of active drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.


Secondary Outcome Measures :
  1. Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment [ Time Frame: 12 weeks after the last dose of active drug ]
    SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug

  2. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to week 24 ]
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.

  3. Percentage of Participants With Post-Treatment Relapse [ Time Frame: Within 12 weeks after the last actual dose of active study drug ]
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.



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

Inclusion Criteria:

  • History of previous direct acting antiviral (DAA) therapy failure; Part 2 only: history of previous direct acting antiviral (DAA) therapy failure and received at least 8 weeks of SOF/ledipasvir; participant must be treatment naïve to all other anti-HCV therapies
  • HCV genotype 1 infection
  • Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control

Exclusion Criteria:

  • Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
  • Discontinuation of the prior DAA treatment for reasons other than virologic failure
  • Confirmed presence of hepatocellular carcinoma
  • Abnormal lab tests

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): NCT02356562


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Eric Cohen, MD AbbVie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02356562     History of Changes
Other Study ID Numbers: M14-224
First Posted: February 5, 2015    Key Record Dates
Results First Posted: November 24, 2017
Last Update Posted: December 20, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AbbVie:
Hepatitis C
Interferon-Free
Treatment Experienced
Chronic Hepatitis C
Hepatitis C Virus

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