Trial Outcomes & Findings for Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan (NCT NCT03020095)
NCT ID: NCT03020095
Last Updated: 2020-10-22
Results Overview
SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
Ravidasvir,Danoprevir/r,RBV
Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.
Ravidasvir: Ravidasvir 200mg tablet administered orally once daily
Danoprevir: Danoprevir 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan
Baseline characteristics by cohort
| Measure |
Ravidasvir,Danoprevir/r,RBV
n=38 Participants
Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.
Ravidasvir: Ravidasvir 200mg tablet administered orally once daily
Danoprevir: Danoprevir 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally
|
|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksSVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration.
Outcome measures
| Measure |
Ravidasvir,Danoprevir/r,RBV
n=38 Participants
Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.
Ravidasvir: Ravidasvir 200mg tablet administered orally once daily
Danoprevir: Danoprevir 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally
|
|---|---|
|
Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
|
38 Participants
|
Adverse Events
Ravidasvir,Danoprevir/r,RBV
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ravidasvir,Danoprevir/r,RBV
n=38 participants at risk
Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.
Ravidasvir: Ravidasvir 200mg tablet administered orally once daily
Danoprevir: Danoprevir 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
Ribavirin: Ribavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
26.3%
10/38 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
15.8%
6/38 • Number of events 6
|
Additional Information
Clinical Trial Disclosures
Ascletis Pharmaceticals Co., Ltd
Phone: 86057187707910
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Ascletis, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The study has been completed at all study sites for at least 3 years.
- Publication restrictions are in place
Restriction type: OTHER