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

Hepatitis C Virus Clinical Trial

— GARNET  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582632
• Other study ID #: M15-684
• Secondary ID: 2015-003370-33
• Status: Completed
• Phase: Phase 3
• Start date: November 24, 2015
• Est. completion date: December 1, 2016

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 1, 2016
• Est. primary completion date: August 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Infection
• Hepatitis C Virus

Intervention

Drug:
• ombitasvir/paritaprevir/ritonavir
Tablet
• dasabuvir
Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Who Achieve SVR12: mITT-GT Population	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	12 weeks after the last actual dose of study drug
Other	Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population	On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA = LLOQ) with at least 6 weeks (defined as study drug duration = 36 days) of treatment. Confidence interval calculated using the Wilson score method.	Up to 8 weeks while on treatment
Other	Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population	Relapse12 is defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration = 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA = LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.	Up to 12 weeks after last dose of study drug
Other	Percentage of Female Participants Responding With SVR12: mITT-GT Population	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	12 weeks after the last actual dose of study drug
Other	Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	Baseline and 12 weeks after the last actual dose of study drug
Primary	Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants With On-Treatment Virologic Failure During Treatment Period	On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA = LLOQ) with at least 6 weeks (defined as study drug duration = 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.	Up to 8 weeks while on treatment
Secondary	Percentage of Participants With Post-Treatment Relapse12	Relapse12 is defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration = 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA = LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.	Up to 12 weeks after last dose of study drug
Secondary	Percentage of Female Participants Responding With SVR12	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12	SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (= LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.	Baseline and 12 weeks after the last actual dose of study drug