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Report for Clinical Trial NCT03020004

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1

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

NCT03020004 Chronic Hepatitis C
MeSH: Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic
HPO: Chronic active hepatitis Chronic hepatitis Hepatitis

4 Interventions

Name: Danoprevir

Description: Danoprevir (DNV) 100mg tablet administered orally twice daily

Type: Drug

Danoprevir,Ritonavir, Peg-IFN,RBV

Name: Ritonavir

Description: Ritonavir 100mg tablet administered orally twice daily

Type: Drug

Danoprevir,Ritonavir, Peg-IFN,RBV

Name: peginterferon alfa-2a

Description: PegIFN subcutaneous injection at 180 mcg weekly

Type: Drug

Danoprevir,Ritonavir, Peg-IFN,RBV

Name: Ribavirin (RBV)

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

Type: Drug

Danoprevir,Ritonavir, Peg-IFN,RBV


Primary Outcomes

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

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

Time: 24 weeks

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 C282Y

Patients who have not obtained a liver biopsy or Fibroscan in the last 1 years will have a study related Fibroscan performed in order to confirm the diagnosis - 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, 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 - Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP > 50 ng/mL - Positive hepatitis A antibody,positive hepatitis B surface antigen,syphilis antibody or HIV antibody at screening - Others as specified in the detailed protocol Inclusion Criteria: - Willing and able to provide written informed consent - Chronic HCV infection (≥ 6 months) ; - Positive HCV antibody - Serum HCV RNA of ≥ 1 × 104 IU/mL - Hepatitis C virus GT1 - Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV - 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. --- C282Y ---

Patients who have not obtained a liver biopsy or Fibroscan in the last 1 years will have a study related Fibroscan performed in order to confirm the diagnosis - 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, 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 - Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP > 50 ng/mL - Positive hepatitis A antibody,positive hepatitis B surface antigen,syphilis antibody or HIV antibody at screening - Others as specified in the detailed protocol Chronic Hepatitis C Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic null --- 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