MedPath

Danoprevir

Generic Name
Danoprevir
Drug Type
Small Molecule
Chemical Formula
C35H46FN5O9S
CAS Number
850876-88-9
Unique Ingredient Identifier
911Z9PCQ5F
Background

Danoprevir has been used in trials studying the treatment of Hepatitis C, Chronic.

Indication

本品应与利托那韦、聚乙二醇干扰素α和利巴韦林联合组成抗病毒治疗方案,用于治疗初治的非肝硬化的基因1b型慢性丙型肝炎成人患者。

Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

Phase 1
Completed
Conditions
HCV
Interventions
First Posted Date
2017-09-20
Last Posted Date
2018-01-17
Lead Sponsor
Ascletis Pharmaceuticals Co., Ltd.
Target Recruit Count
18
Registration Number
NCT03288636
Locations
🇨🇳

The first hospital of Zhejiang province, Hangzhou, Zhejiang, China

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

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2017-01-13
Last Posted Date
2018-07-26
Lead Sponsor
Ascletis Pharmaceuticals Co., Ltd.
Target Recruit Count
70
Registration Number
NCT03020004

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

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2017-01-13
Last Posted Date
2020-10-22
Lead Sponsor
Ascletis Pharmaceuticals Co., Ltd.
Target Recruit Count
38
Registration Number
NCT03020095

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

Phase 3
Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2017-01-13
Last Posted Date
2021-03-23
Lead Sponsor
Ascletis Pharmaceuticals Co., Ltd.
Target Recruit Count
141
Registration Number
NCT03020082

Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2017-01-13
Last Posted Date
2018-06-29
Lead Sponsor
Ascletis Pharmaceuticals Co., Ltd.
Target Recruit Count
18
Registration Number
NCT03020134

Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2017-01-13
Last Posted Date
2017-01-13
Lead Sponsor
Ascletis Pharmaceuticals Co., Ltd.
Target Recruit Count
18
Registration Number
NCT03019991

A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis

Phase 2
Completed
Conditions
Hepatitis C, Chronic
Interventions
Drug: peginterferon alfa-2a [Pegasys]
First Posted Date
2012-12-13
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
61
Registration Number
NCT01749150

A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2012-10-25
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
18
Registration Number
NCT01714154

A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2012-07-31
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
33
Registration Number
NCT01654211
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