Trial Outcomes & Findings for Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II (NCT NCT03020004)
NCT ID: NCT03020004
Last Updated: 2018-07-26
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
70 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
Danoprevir,Ritonavir, Peg-IFN,RBV
Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) for 12 weeks.
Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly
Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
Baseline characteristics by cohort
| Measure |
Danoprevir,Ritonavir, Peg-IFN,RBV
n=70 Participants
Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) for 12 weeks.
Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly
Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)
|
|---|---|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
70 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
|
PRIMARY outcome
Timeframe: 24 weeksSVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
Outcome measures
| Measure |
Danoprevir,Ritonavir, Peg-IFN,RBV
n=70 Participants
Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) for 12 weeks.
Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly
Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)
|
|---|---|
|
Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
|
66 Participants
|
Adverse Events
Danoprevir,Ritonavir, Peg-IFN,RBV
Serious events: 1 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Danoprevir,Ritonavir, Peg-IFN,RBV
n=70 participants at risk
Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) for 12 weeks.
Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly
Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)
|
|---|---|
|
Gastrointestinal disorders
acute pancreatitis
|
1.4%
1/70 • Number of events 1
|
Other adverse events
| Measure |
Danoprevir,Ritonavir, Peg-IFN,RBV
n=70 participants at risk
Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) for 12 weeks.
Danoprevir: Danoprevir (DNV) 100mg tablet administered orally twice daily
Ritonavir: Ritonavir 100mg tablet administered orally twice daily
peginterferon alfa-2a: PegIFN subcutaneous injection at 180 mcg weekly
Ribavirin (RBV): Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)
|
|---|---|
|
Investigations
Neutrophil count decreased
|
90.0%
63/70 • Number of events 85
|
|
Investigations
White blood cell decreased
|
82.9%
58/70 • Number of events 69
|
Additional Information
Clinical Trial Disclosures
Ascletis Pharmaceuticals Co., Ltd
Phone: +86057185389732
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