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

NCT03020095 | Completed Phase 2 Results DMC

• 1 other identifier: ASC162001
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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

Chronic Hepatitis C

Keywords

Ravidasvir; HCV GT1; SVR12; Danoprevir/r

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment

  SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration.

  12 weeks

Study Arms (1)

Ravidasvir,Danoprevir/r,RBV

EXPERIMENTAL

Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.

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

Interventions

Ravidasvir DRUG

Ravidasvir 200mg tablet administered orally once daily

Also known as: Asclevir

Ravidasvir,Danoprevir/r,RBV

Danoprevir DRUG

Danoprevir 100mg tablet administered orally twice daily

Also known as: Ganovo

Ravidasvir,Danoprevir/r,RBV

Ritonavir DRUG

Ritonavir 100mg tablet administered orally twice daily

Ravidasvir,Danoprevir/r,RBV

Ribavirin DRUG

Ribavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally

Also known as: Ribasphere®

Ravidasvir,Danoprevir/r,RBV

Eligibility Criteria

• Age: 20 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) , HCV RNA ≥ 1 × 104 IU/mL
• Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
• Chronic liver disease consistent with CHC infection without cirrhosis as determined by biopsy obtained within the past calendar 36 months using one of the liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂ 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 3 years will have a study related Fibroscan performed in order to confirm the diagnosis. Liver biopsy will be performed by investigator's judgement
• All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin
• Others as specified in detailed protocol.

You may not qualify if:

• Pregnant or lactating women.
• History or presence of decompensated liver disease (history of ascites, hepatic encephalopathy, HCC, or bleeding esophageal varices)
• Presence or history of non-hepatitis C chronic liver disease, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy
• Positive hepatitis B surface antigen or HIV antibody at screening
• History or presence of liver cirrhosis
• History of severe psychiatric disease, including psychosis and/or depression, who is not able to participate or able to give written informed consent and to comply with the study restrictions
• History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin)
• History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia's requiring ongoing treatment, unstable angina or other unstable, uncontrolled or significant cardiovascular disease within 6 months). Patients with stable coronary artery disease (e.g., 6 months after by-pass surgery, angioplasty with or without stent placement, etc.) as confirmed by a cardiologist will be permitted. In addition, patients with documented or presumed unstable coronary artery disease, cardiovascular disease, or cerebrovascular disease should not be enrolled.
• Any patient with an increased risk for anemia (e.g., thalassemia, sickle cell anemia, or spherocytosis) or for whom anemia would be medically problematic
• History of pre-existing renal disease, patients with a history of nephrolithiasis will be allowed
• Others as specified in detailed protocol.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

ravidasvir; danoprevir; Ritonavir; 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 2
• 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: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: February 1, 2017
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share