Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients
|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: NCT02576314|
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Infection||Drug: sofosbuvir and daclatasvir Drug: ledipasvir/sofosbuvir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||March 15, 2018|
Active Comparator: Sofosbuvir and Daclatasvir
Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.
Drug: sofosbuvir and daclatasvir
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
Active Comparator: Ledipasvir/sofosbuvir
Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks.
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.
- Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy [ Time Frame: Post treatment Week 12 ]SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication
- Incidence of adverse events leading to permanent discontinuation of study drug [ Time Frame: Baseline up to Week 12 ]
- Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment [ Time Frame: Baseline up to Week 12 ]
- HCV RNA levels and change during and after treatment [ Time Frame: Baseline up to Week 12 ]
- Treatment adherence [ Time Frame: Baseline to Week 12 ]To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)
- Change in health related quality of life [ Time Frame: Baseline to Week 24 ]To evaluate the change in health-related quality of life during 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): NCT02576314
|Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital|
|Beijing, Beijing, China, 100039|
|China, Hong Kong|
|Humanity and Health GI and Liver Centre|
|Hong Kong, Hong Kong, China, 00852|
|Principal Investigator:||George Lau, MD||Humanity and Health GI and Liver Centre|