Trial Outcomes & Findings for Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III (NCT NCT03020082)

Last Updated: 2021-03-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

141 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-03-23

Participant milestones
Measure	Danoprevir, Ritonavir, Peg-IFN,RBV Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks; Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks; peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks; RBV: RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
Overall Study STARTED	141
Overall Study COMPLETED	138
Overall Study NOT COMPLETED	3

Withdrawal data not reported

Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III

Baseline characteristics by cohort
Measure	Danoprevir, Ritonavir, Peg-IFN,RBV n=141 Participants Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks; Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks; peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks; RBV: RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
Age, Continuous	42 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	141 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

Timeframe: 12 weeks

Outcome measures
Measure	Danoprevir, Ritonavir, Peg-IFN,RBV n=141 Participants Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks; Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks; peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks; RBV: RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	136 Participants

Serious events: 5 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events
Measure	Danoprevir, Ritonavir, Peg-IFN,RBV n=141 participants at risk Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks; Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks; peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks; RBV: RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
Blood and lymphatic system disorders neutropenia	0.71% 1/141 • 24 weeks
Cardiac disorders Ventricular tachyarrhythmia	0.71% 1/141 • 24 weeks
Infections and infestations Tuberculosis	0.71% 1/141 • 24 weeks
Metabolism and nutrition disorders Transient ischemic attack	0.71% 1/141 • 24 weeks
Eye disorders Acquired digital fibrokeratoma	0.71% 1/141 • 24 weeks

Other adverse events
Measure	Danoprevir, Ritonavir, Peg-IFN,RBV n=141 participants at risk Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks. Danoprevir: Danoprevir (DNV)administered orally 100mg BID for 12 weeks; Ritonavir: Ritonavir administered orally 100mg BID for 12 weeks; peginterferon alfa-2a: PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks; RBV: RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
Blood and lymphatic system disorders Anemia	53.9% 76/141 • 24 weeks
Infections and infestations Fever	37.6% 53/141 • 24 weeks

Ascletis Pharmaceticals Co., Ltd

Phone: 86057187707910

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