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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

Ravidasvir,Danoprevir/r,RBV

Name: Danoprevir

Description: Danoprevir 100mg tablet administered orally twice daily

Type: Drug

Ravidasvir,Danoprevir/r,RBV

Name: Ritonavir

Description: Ritonavir 100mg tablet administered orally twice daily

Type: Drug

Ravidasvir,Danoprevir/r,RBV

Name: Ribavirin

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

Type: Drug

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

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:
Chronic active hepatitis
Genes 5
ALMS1 KRT8 AIRE C4B KRT18
Chronic hepatitis
Genes 11
ALMS1 KRT8 IL21R AIRE RFXAP C4B RFXANK CD40LG KRT18 RFX5 CIITA
Hepatitis
Genes 90
CD247 CTNNB1 ATP7B CASP10 PIEZO1 GUSB BLNK SHPK CYP7A1 IL17RA IGF2R CASP8 SH2D1A SLC25A15 BTK BTK C4B CD79B VPS33B XIAP SERPINA1 PIK3R1 GLIS3 POU2AF1 CIITA FOXP3 TPP2 RFX5 CIITA RASGRP1 RFXANK SLC25A15 AXIN1 TCF4 CD3D TP53 IL12A PRKCD CD40LG BTK IGHM IL17RC ALMS1 TRAF3IP2 KRT8 FAS LRRC8A FAS IL17F XIAP SPIB C1S RFX5 RFXAP MST1 TTC7A COG8 SKIV2L VIPAS39 IGLL1 PDGFRL TNFSF15 HSD3B7 CD3E AMACR ATP7B FASLG RFXANK IL12RB1 TCF3 CD79A KRT18 IRF5 MET PIK3CA MMEL1 ITCH TBX19 IL21R AIRE RFXAP TTC7A CLEC7A GPR35 ATP7A CYP7B1 STAT1 PGM1 APC TNPO3