Neutrino Regimen for Treatment-experienced HCV GT1 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: NCT02480686|
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : August 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Infection||Drug: SOF+PEG+RBV||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks.
Sofosbuvir (SOF) 400 mg tablet is administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection; Ribavirin (RBV) was administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
- Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Post treatment Week 12 ]SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
- Proportion of participants with adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Baseline up to Week 24 ]Adverse events leading to permanent discontinuation of study drug(s)
- Change in HCV RNA From Baseline to Week 12 [ Time Frame: Baseline up to Week 24 ]
- Proportion of participants with on-treatment virologic breakthrough and relapse [ Time Frame: Baseline up to Week 24 ]
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): NCT02480686
|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|
|Principal Investigator:||Guofeng Chen, MD||302 Hospital|