SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03020004

Developed by Shray Alag, 2019.
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 Hepatitis C Hepatitis, Chronic Hepatitis C, 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 Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic null --- C282Y ---



HPO Nodes


HPO:
Chronic active hepatitis
Genes 5
KRT8 ALMS1 C4B KRT18 AIRE
Chronic hepatitis
Genes 11
KRT8 ALMS1 RFXANK C4B KRT18 CIITA AIRE IL21R RFX5 RFXAP CD40LG
Hepatitis
Genes 74
TTC7A MST1 TRAF3IP2 TPP2 TBX19 IL12A MET IL12RB1 RASGRP1 TCF4 HSD3B7 KRT8 SERPINA1 TCF3 VIPAS39 ATP7A IGF2R MMEL1 ATP7B ALMS1 SPIB KRT18 VPS33B CIITA PDGFRL PIK3CA GPR35 CYP7A1 GUSB PIK3R1 AMACR RFXANK SHPK IGHM PIEZO1 SLC25A15 BTK IL21R CD40LG BLNK GLIS3 APC CLEC7A AIRE LRRC8A CASP8 POU2AF1 XIAP CASP10 C1S CYP7B1 PRKCD CD79A CD79B IRF5 C4B IL17RC IL17RA IGLL1 CTNNB1 FAS SKIV2L FASLG SH2D1A RFX5 IL17F RFXAP TNFSF15 TNPO3 PGM1 STAT1 TP53 AXIN1 FOXP3