Clinical Trials Directory

Trials / Completed

CompletedNCT03020095

Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan

Phase 2 Study To Investigate the Efficacy, Safety And Pharmacokinetics Of Ravidasvir In Combination With Ritonavir-boosted Danoprevir And Ribavirin In Treatment-naive Non-cirrhotic Taiwanese Patients Who Have Chronic Hepatitis C Genotype 1

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Ascletis Pharmaceuticals Co., Ltd. · Industry
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.

Conditions

Interventions

TypeNameDescription
DRUGRavidasvirRavidasvir 200mg tablet administered orally once daily
DRUGDanoprevirDanoprevir 100mg tablet administered orally twice daily
DRUGRitonavirRitonavir 100mg tablet administered orally twice daily
DRUGRibavirinRibavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally

Timeline

Start date
2015-08-01
Primary completion
2016-08-01
Completion
2017-02-01
First posted
2017-01-13
Last updated
2020-10-22
Results posted
2020-10-22

Source: ClinicalTrials.gov record NCT03020095. Inclusion in this directory is not an endorsement.