Phase 3 Study of Yimitasvir Phosphate Capsules
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|ClinicalTrials.gov Identifier: NCT03487107|
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : August 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic HCV Infection||Drug: SOF Drug: DAG181||Phase 3|
A phase III, multicenter, single-arm, open-label study to assess the safety, tolerability and antiviral activity of DAG181/SOF combination for 12 weeks in adult subjects with chronic genotype 1 HCV infection.
Approximately 360 HCV genotype 1 subjects without cirrhosis will be enrolled, treatment-experienced subjects are ≤20%. All subjects will receive DAG181 100 mg/ SOF 400 mg once daily for 12 weeks，with subsequent observation for 24 weeks after cessation of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||362 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Single-arm, Open-label Study to Investigate the Efficacy and Safety of Yimitasvir Phosphate (DAG181)/Sofosbuvir(SOF) Combination for 12 Weeks in Subjects With Chronic Genotype 1 HCV Infection|
|Actual Study Start Date :||April 17, 2018|
|Actual Primary Completion Date :||March 28, 2019|
|Actual Study Completion Date :||June 25, 2019|
Experimental: SOF 400 mg+DAG181 100 mg
Patients with genotype 1 HCV infection without cirrhosis will receive SOF 400 mg+DAG181 100 mg for 12 weeks.
400 mg tablet administered orally once daily
100 mg capsule administered orally once daily
Other Name: Yimitasvir
- Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy(SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after discontinuation of therapy
- Safety and tolerability were evaluated based on adverse events [ Time Frame: Up to posttreatment week 24 ]Collecting all adverse events during the whole study
- Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) at 4 and 24 weeks after discontinuation of therapy, respectively.
- HCV RNA change from baseline [ Time Frame: Up to posttreatment week 24 ]the quantification of HCV RNA during and after treatment compared with baseline
- Percentage of subjects with virologic failure [ Time Frame: Up to posttreatment week 24 ]
On-treatment virologic failure:
- confirmed HCV RNA ≥ the lower limit of quantitation (LLOQ) after having previously had HCV RNA <the lower limit of quantitation (LLOQ) while on treatment;
- confirmed ≥ 1 log10 IU/mL increase in HCV RNA from nadir while on treatment;
- HCV RNA persistently ≥the lower limit of quantitation (LLOQ) through 8 weeks of treatment.
- Confirmed HCV RNA ≥the lower limit of quantitation (LLOQ) during the posttreatment period having achieved HCV RNA <the lower limit of quantitation (LLOQ) at last on-treatment visit.
- Percentage of subjects with viral resistance to DAG181 and/or SOF [ Time Frame: Up to posttreatment week 24 ]Monitoring HCV virus resistance at baseline, during and after 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): NCT03487107
|Study Chair:||Lai Wei, Doctor||Peking University People's Hospital|