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Report for Clinical Trial NCT03020095

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase 2 Study To Investigate the Efficacy, Safety And Pharmacokinetics Of Ravidasvir In Combination With Ritonavir-boosted Danoprevir And Ribavirin In Treatment-naive Non-cirrhotic Taiwanese Patients Who Have Chronic Hepatitis C Genotype 1

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.

NCT03020095 Chronic Hepatitis C
MeSH:Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic
HPO:Chronic active hepatitis Chronic hepatitis Hepatitis

4 Interventions

Name: Ravidasvir

Description: Ravidasvir 200mg tablet administered orally once daily
Type: Drug
Group Labels: 1

Ravidasvir,Danoprevir/r,RBV

Name: Danoprevir

Description: Danoprevir 100mg tablet administered orally twice daily
Type: Drug
Group Labels: 1

Ravidasvir,Danoprevir/r,RBV

Name: Ritonavir

Description: Ritonavir 100mg tablet administered orally twice daily
Type: Drug
Group Labels: 1

Ravidasvir,Danoprevir/r,RBV

Name: Ribavirin

Description: Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally
Type: Drug
Group Labels: 1

Ravidasvir,Danoprevir/r,RBV


Primary Outcomes

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

Measure: Proportion of participants with Sustained Virologic Response 12 weeks after end of treatment (SVR12)

Time: 12 weeks

Secondary Outcomes

Measure: Proportion of participants permanently discontinuing study drug(s) due to an adverse event (AE)

Time: 24 weeks

Description: SVR24, defined as undetectable HCV RNA 24 weeks after the last day of study drug administration

Measure: Proportion of participants with Sustained virologic response 24 weeks after end of treatment

Time: 24 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 C282Y

- 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). --- C282Y ---



HPO Nodes


HPO: