Clinical Trials Logo

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
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02907996 - Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Not yet recruiting NCT02893046 - HCV Care Pathway in Ile-de-France N/A
Completed NCT01428063 - Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials Phase 2
Completed NCT01396005 - A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123) Phase 1
Completed NCT01195181 - Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice. Phase 4
Completed NCT00219999 - Hepatitis C Virus and the Humoral Immune System N/A
Completed NCT02243293 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection Phase 2/Phase 3
Completed NCT02265237 - A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1) Phase 3
Not yet recruiting NCT06104046 - Prevalence of Seroconversion of Hepatitis c Virus Among Children With CKD on Regular Hemodialysis
Completed NCT02604017 - A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection Phase 3
Withdrawn NCT00947245 - Japanese Bridging Study Conducted in the United States Phase 1
Completed NCT01713283 - Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection Phase 2
Completed NCT01458535 - A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Phase 2
Completed NCT01479881 - A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus Phase 1
Completed NCT01241773 - TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir Phase 1
Completed NCT01193361 - Ph IIA Study (SOC +/- NS5B) Phase 2
Completed NCT01006031 - Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4 Phase 2/Phase 3
Completed NCT00819026 - Observational Trial of Hepatitis C Virus Infected Patients on Calcineurin Inhibitors N/A
Completed NCT00382798 - Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin Phase 1/Phase 2