Danoprevir

Generic Name: Danoprevir

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₃₅H_₄₆FN_₅O_₉S

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。

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Virus Genotype1 Infected Subjects.

Phase 2

Completed

Conditions: HCV

Interventions: Drug: Ravidasvir
Drug: Ravidasvir Placebo
Drug: Danoprevir
Drug: Danoprevir Placebo
Drug: Ritonavir
Drug: Ritonavir Placebo
Drug: Ribavirin 100 MG
Drug: Ribavirin Placebo

First Posted Date: 2017-12-05

Last Posted Date: 2020-07-28

Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

Target Recruit Count: 425

Registration Number: NCT03362814

Locations: 🇨🇳
Peking University People's hospital, Beijing, Beijing, China

Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

Phase 1

Completed

Conditions: HCV

Interventions: Drug: Danoprevir
Drug: Placebo
Drug: Ritonavir
Drug: Ravidasvir

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 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III

Phase 3

Completed

Conditions: Chronic Hepatitis C

Interventions: Drug: Danoprevir
Drug: Ritonavir
Drug: peginterferon alfa-2a
Drug: RBV

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: Drug: Placebo
Drug: Ravidasvir
Drug: Danoprevir
Drug: Ritonavir

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

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: Drug: Ravidasvir
Drug: Danoprevir
Drug: Ritonavir
Drug: Ribavirin

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 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II

Phase 2

Completed

Conditions: Chronic Hepatitis C

Interventions: Drug: Danoprevir
Drug: Ritonavir
Drug: peginterferon alfa-2a
Drug: Ribavirin (RBV)

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

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Danoprevir
Drug: Placebo
Drug: Ritonavir

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 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: Drug: danoprevir
Drug: ritonavir
Drug: setrobuvir

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: Drug: danoprevir
Drug: placebo
Drug: ritonavir

First Posted Date: 2012-07-31

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 33

Registration Number: NCT01654211

A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: atazanavir
Drug: danoprevir
Drug: ritonavir
Drug: tenofovir disoproxil fumarate

First Posted Date: 2012-05-07

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 40

Registration Number: NCT01592305

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