Trials / Completed
CompletedNCT03020004
Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Danoprevir | Danoprevir (DNV) 100mg tablet administered orally twice daily |
| DRUG | Ritonavir | Ritonavir 100mg tablet administered orally twice daily |
| DRUG | peginterferon alfa-2a | PegIFN subcutaneous injection at 180 mcg weekly |
| DRUG | Ribavirin (RBV) | Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2016-11-01
- Completion
- 2017-02-01
- First posted
- 2017-01-13
- Last updated
- 2018-07-26
- Results posted
- 2018-02-07
Source: ClinicalTrials.gov record NCT03020004. Inclusion in this directory is not an endorsement.