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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

NCT ID: NCT02356562

Last Updated: 2017-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-03

Study Completion Date

2017-07-07

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis C Infection

Keywords

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Hepatitis C Interferon-Free Treatment Experienced Chronic Hepatitis C Hepatitis C Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir

Sofosbuvir

Intervention Type DRUG

tablet

Ribavirin

Intervention Type DRUG

tablet

Interventions

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ombitasvir/paritaprevir/ritonavir and dasabuvir

tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir

Intervention Type DRUG

Sofosbuvir

tablet

Intervention Type DRUG

Ribavirin

tablet

Intervention Type DRUG

Other Intervention Names

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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 Sovaldi RBV

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Cohen, MD

Role: STUDY_DIRECTOR

AbbVie

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26596948 (View on PubMed)

Other Identifiers

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M14-224

Identifier Type: -

Identifier Source: org_study_id