A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults (GARNET)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Infection; Hepatitis C Virus

Treatments: Drug: ombitasvir/paritaprevir/ritonavir; Drug: dasabuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02582632

M15-684

2015-003370-33 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).

Enrollment: 166 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chronic HCV infection at Screening.
2. Screening laboratory result indicating HCV genotype 1b infection.
3. Treatment-naïve and non-cirrhotic.

Exclusion criteria

1. HCV genotype or subtype other than GT1b.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
3. Any current or past clinical evidence of cirrhosis.
4. Screening laboratory analyses that shows abnormal results.
5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 1 patient group

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

Experimental group

Description:

Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks

Treatment:

Drug: dasabuvir

Drug: ombitasvir/paritaprevir/ritonavir