Back to resultsA 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
Primary Purpose
Chronic Hepatitis C Infection
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ombitasvir/paritaprevir/ritonavir and dasabuvir
Sofosbuvir
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Hepatitis C, Interferon-Free, Treatment Experienced, Chronic Hepatitis C, Hepatitis C Virus
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3-DAA with or without SOF and RBV
Arm Description
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
Outcomes
Primary Outcome Measures
Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment
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
Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug
Percentage of Participants With On-treatment Virologic Failure
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.
Percentage of Participants With Post-Treatment Relapse
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02356562
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 3, 2015 (Actual)
Primary Completion Date
October 28, 2016 (Actual)
Study Completion Date
July 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection
Keywords
Hepatitis C, Interferon-Free, Treatment Experienced, Chronic Hepatitis C, Hepatitis C Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3-DAA with or without SOF and RBV
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ombitasvir/paritaprevir/ritonavir and dasabuvir
Other Intervention Name(s)
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
Intervention Description
tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
RBV
Intervention Description
tablet
Primary Outcome Measure Information:
Title
Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment
Description
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.
Time Frame
12 weeks after the last dose of active drug
Secondary Outcome Measure Information:
Title
Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
Description
SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug
Time Frame
12 weeks after the last dose of active drug
Title
Percentage of Participants With On-treatment Virologic Failure
Description
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.
Time Frame
Up to week 24
Title
Percentage of Participants With Post-Treatment Relapse
Description
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.
Time Frame
Within 12 weeks after the last actual dose of active study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Cohen, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26596948
Citation
King JR, Dutta S, Cohen D, Podsadecki TJ, Ding B, Awni WM, Menon RM. Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir. Antimicrob Agents Chemother. 2015 Nov 23;60(2):855-61. doi: 10.1128/AAC.01913-15. Print 2016 Feb.
Results Reference
derived
Learn more about this trial
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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