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

NCT03020082 | Completed Phase 3 Results DMC

• 1 other identifier: ASC08201503
• Study Type: interventional
• Target: 141
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Hepatitis C

Keywords

Danoprevir; non-cirrhotic; Chinese HCV G1; SVR12

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Study Arms (1)

Danoprevir, Ritonavir, Peg-IFN,RBV

EXPERIMENTAL

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.

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

Interventions

Danoprevir DRUG

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

Also known as: ASC08

Danoprevir, Ritonavir, Peg-IFN,RBV

Ritonavir DRUG

Ritonavir administered orally 100mg BID for 12 weeks;

Danoprevir, Ritonavir, Peg-IFN,RBV

peginterferon alfa-2a DRUG

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

Also known as: Peg-IFN

Danoprevir, Ritonavir, Peg-IFN,RBV

RBV DRUG

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

Also known as: Ribasphere®

Danoprevir, Ritonavir, Peg-IFN,RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Related Publications (1)

• 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.

  PMID: 31608213 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

danoprevir; Ritonavir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Ascletis Pharmaceticals Co., Ltd

xin.li@ascletis.com

86057187707910

Study Officials

• Huoling Tang, PhD

  Ascletis Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 13, 2017
• Study Start: June 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 23, 2021
• Results First Posted: March 23, 2021

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share