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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Danoprevir

Ritonavir

peginterferon alfa-2a

RBV

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Danoprevir, non-cirrhotic, Chinese HCV G1, SVR12

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Willing and able to provide written informed consent
Chronic HCV infection (≥ 6 months)
Serum HCV RNA of ≥ 1 × 104 IU/mL are documented
Hepatitis C virus GT1
Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa during screening period, or liver biopsy determined 1 year before recruiting (Metavir score ˂ 3);(2) during screening period 9.6<Fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis.
Others as specified in the detailed protocol

Exclusion Criteria:

Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for liver cirrhosis patients
Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)
History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP > 50 ng/mL
Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody
Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself.
Patients with obvious cardiovascular dysfunction
Pregnant or nursing female, nor unwilling to take reliable contraception
Others as specified in the detailed protocol

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Danoprevir, Ritonavir, Peg-IFN,RBV

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

Secondary Outcome Measures

Full Information

NCT ID

NCT03020082

First Posted

January 5, 2017

Last Updated

February 28, 2021

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03020082

Brief Title

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

Official Title

A Multi-centered, Open Label, Phase III Study on Efficacy, Safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ascletis Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

Danoprevir, non-cirrhotic, Chinese HCV G1, SVR12

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Danoprevir, Ritonavir, Peg-IFN,RBV

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Danoprevir

Other Intervention Name(s)

ASC08

Intervention Description

Danoprevir (DNV)administered orally 100mg BID for 12 weeks;

Intervention Type

Drug

Intervention Name(s)

Ritonavir

Intervention Description

Ritonavir administered orally 100mg BID for 12 weeks;

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a

Other Intervention Name(s)

Peg-IFN

Intervention Description

PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;

Intervention Type

Drug

Intervention Name(s)

RBV

Other Intervention Name(s)

Ribasphere®

Intervention Description

RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.

Primary Outcome Measure Information:

Title

Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Willing and able to provide written informed consent Chronic HCV infection (≥ 6 months) Serum HCV RNA of ≥ 1 × 104 IU/mL are documented Hepatitis C virus GT1 Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa during screening period, or liver biopsy determined 1 year before recruiting (Metavir score ˂ 3);(2) during screening period 9.6<Fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis. Others as specified in the detailed protocol Exclusion Criteria: Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for liver cirrhosis patients Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease) History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP > 50 ng/mL Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself. Patients with obvious cardiovascular dysfunction Pregnant or nursing female, nor unwilling to take reliable contraception Others as specified in the detailed protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huoling Tang, PhD

Organizational Affiliation

Ascletis Pharmaceuticals Co., Ltd.

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31608213

Citation

Wei L, Shang J, Ma Y, Xu X, Huang Y, Guan Y, Duan Z, Zhang W, Gao Z, Zhang M, Li J, Jia J, Yang Y, Wen X, Wang M, Jia Z, Ning B, Chen Y, Qi Y, Du J, Jiang J, Tong L, Xie Y, Wu JJ. Efficacy and Safety of 12-week Interferon-based Danoprevir Regimen in Patients with Genotype 1 Chronic Hepatitis C. J Clin Transl Hepatol. 2019 Sep 28;7(3):221-225. doi: 10.14218/JCTH.2019.00018. Epub 2019 Jul 22.

Results Reference

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

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