A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection (Turquoise-IV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02216422|
Recruitment Status : Completed
First Posted : August 15, 2014
Results First Posted : June 29, 2016
Last Update Posted : June 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Virus (HCV) Infection||Drug: Ombitasvir/Paritaprevir/Ritonavir Drug: Dasabuvir Drug: Ribavirin (RBV)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks
Tablet; paritaprevir co-formulated with ritonavir and ombitasvir
Other Name: ABT-333
Drug: Ribavirin (RBV)
- Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment [ Time Frame: Post-treatment Day 1 to Post-treatment Week 12 ]Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
- Percentage of Participants With On-Treatment Virologic Failure [ Time Frame: Day 1 through Week 12 ]On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 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 active study drug duration ≥ 36 days] of treatment.
- Percentage of Participants With Post-Treatment Relapse [ Time Frame: Post-treatment Day 1 to Post-treatment Week 12 ]Post- Treatment Relapse 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 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216422
|Study Director:||Rolando M Viani, MD||AbbVie|