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Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

NCT ID: NCT02399345

Last Updated: 2016-12-12

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

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-11-30

Brief Summary

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This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis

Detailed Description

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Conditions

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Chronic Hepatitis C Virus (HCV Infection Genotype 1)

Keywords

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Treatment naive Hepatitis C Genotype 1

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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Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV

Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir, dasabuvir

Intervention Type DRUG

tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

sofosbuvir (SOF)

Intervention Type DRUG

tablet

ribavirin (RBV)

Intervention Type DRUG

tablet

Interventions

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ombitasvir/paritaprevir/ritonavir, dasabuvir

tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Intervention Type DRUG

sofosbuvir (SOF)

tablet

Intervention Type DRUG

ribavirin (RBV)

tablet

Intervention Type DRUG

Other Intervention Names

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Viekira PAK ombitasvir also known as ABT-267 paritaprevir also known as ABT-450 dasabuvir also known as ABT-333

Eligibility Criteria

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Inclusion Criteria

1. Male or female at least 18 years of age at time of screening
2. Chronic Hepatitis C virus (HCV) infection prior to study enrollment
3. Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only
4. Absence of cirrhosis and advanced bridging fibrosis

Exclusion Criteria

1. Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
2. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator
3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score \> 2 or an Ishak score \> 3
4. Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration
5. Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents
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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Australia Canada New Zealand

Related Links

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http://www.rxabbvie.com/

Related info.

Other Identifiers

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2014-005280-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-310

Identifier Type: -

Identifier Source: org_study_id