Clinical trial NCT02582632: A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
Official title: An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Infection
Hepatitis C Virus
Keywords: Hepatitis C Virus
Interferon-Free
Ribavirin-Free
Hepatitis C
Hepatitis C Genotype 1b
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants With On-Treatment Virologic Failure During Treatment Period
timeFrame: Up to 8 weeks while on treatment
measure: Percentage of Participants With Post-Treatment Relapse12
timeFrame: Up to 12 weeks after last dose of study drug
measure: Percentage of Female Participants Responding With SVR12
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12
timeFrame: Baseline and 12 weeks after the last actual dose of study drug
Other outcomes:
measure: Percentage of Participants Who Achieve SVR12: mITT-GT Population
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population
timeFrame: Up to 8 weeks while on treatment
measure: Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population
timeFrame: Up to 12 weeks after last dose of study drug
measure: Percentage of Female Participants Responding With SVR12: mITT-GT Population
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population
timeFrame: Baseline and 12 weeks after the last actual dose of study drug
Locations:
Study officials:
affiliation: AbbVie
name: Emily Dumas, PhD
role: STUDY_DIRECTOR
References:
citation: Welzel TM, Asselah T, Dumas EO, Zeuzem S, Shaw D, Hazzan R, Forns X, Pilot-Matias T, Lu W, Cohen DE, Feld JJ. Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):494-500. doi: 10.1016/S2468-1253(17)30071-7. Epub 2017 Apr 14.