Triple or Quadruple Combination DAAs Treatment for Subjects With HCV GT 1b Infection
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|ClinicalTrials.gov Identifier: NCT03794258|
Recruitment Status : Withdrawn (Can not recruit the patients due to the pandemic of COVID-19)
First Posted : January 7, 2019
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|HCV Infection||Drug: SOF+DCV+CDI-31244 Drug: SOF+DCV+CDI-31244+ASV||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2a, Open-label, Randomized Study of the Safety and Preliminary Efficacy of Triple or Quadruple Combination DAAs With Ultra-short Duration Therapy in Subjects With HCV Genotype 1b Infection (YANGTZE Study)|
|Actual Study Start Date :||May 1, 2019|
|Actual Primary Completion Date :||April 15, 2020|
|Actual Study Completion Date :||April 30, 2020|
Subjects will receive two weeks of sofosbuvir, daclatasvir, and CDI-31244 if they achieve HCV RNA < 500 IU/mL on Day 2 and HCV RNA < LLOQ (< 25 IU/mL) on Week 1.
Sofosbuvir (SOF) 400 mg administered orally once daily; Daclatasvir (DCV) 60 mg administered orally once daily; CDI-31244 400 mg administered orally once daily.
Subjects will receive two weeks of sofosbuvir, daclatasvir, CDI-31244 and asunaprevir if they achieve HCV RNA < 500 IU/mL on Day 2 and HCV RNA < LLOQ (< 25 IU/mL) on Week 1.
Sofosbuvir (SOF) 400 mg administered orally once daily; Daclatasvir (DCV) 60 mg administered orally once daily; CDI-31244 400 mg orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
- 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.
- Frequency and severity of adverse events [ Time Frame: Baseline up to Week 24 ]
- Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment [ Time Frame: Baseline up to Week 24 ]
- HCV RNA levels and change during and after treatment [ Time Frame: Baseline up to Week 24 ]
- Proportion of participants with on-treatment virologic breakthrough and relapse [ Time Frame: Baseline up to Week 24 ]Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.
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): NCT03794258
|Humanity & Health Research Centre|
|Hong Kong, Hong Kong SAR, Hong Kong|
|Principal Investigator:||Georg Lau, MD||Humanity & Health Research Centre|