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Report for Clinical Trial NCT01995266

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3, Open-Label Study With Daclatasvir And Asunaprevir (DUAL) for Subjects With Genotype 1b Chronic Hepatitis C (HCV) Infection Who Are Intolerant or Ineligible to Interferon Alfa Therapies With or Without Ribavirin

Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen

NCT01995266 Hepatitis C
MeSH: Hepatitis C Hepatitis
HPO: Hepatitis

2 Interventions

Name: Asunaprevir

Type: Drug

Asunaprevir + Daclatasvir

Name: Daclatasvir

Type: Drug

Asunaprevir + Daclatasvir


Primary Outcomes

Description: SVR was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 24.

Measure: Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24)

Time: 24 Weeks after treatment discontinuation (Follow-up Week 24)

Secondary Outcomes

Description: SVR12 was defined as HCV RNA < LLOQ target detected or not detected at post-treatment follow-up Week 12. For SVR12, missing HCV RNA data at follow-up Week 12 was imputed using the Next Value Carried Backwards (NVCB) approach.

Measure: Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12)

Time: 12 Weeks after treatment discontinuation (Follow-up Week 12)

Description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.

Measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Death, and AEs Leading to Discontinuation

Time: 7 days after treatment discontinuation

Description: Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 24.

Measure: Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24

Time: 24 Weeks after treatment discontinuation (Follow-up Week 24)

Description: Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBASĀ® Taqman quantitative RT-PCR assay, v2.0. The lower and upper limits of quantitation (LOQs) of the assay for HCV GT-1 were 25 IU/mL and 3.91 X10^8 IU/mL, respectively; the limit of detection was ~ 10 IU/mL

Measure: Percentage of Participants With HCV RNA< LLOQ Target Not Detected at the End of Treatment (Week 24)

Time: Week 24 (End-of Treatment)

Description: RVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 4.

Measure: Number of Participants With Rapid Virologic Response (RVR)

Time: Treatment Week 4

Description: cEVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 12.

Measure: Percentage of Participants With Complete Early Virologic Response (cEVR)

Time: Treatment Week 12

Description: eRVR was defined as HCV RNA < LLOQ, target not detected at treatment Weeks 4 and 12.

Measure: Number of Participants With Extended Rapid Virologic Response (eRVR)

Time: Treatment Week 4 and Week 12

Description: Antiviral efficacy is measured by the number of participants with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at End of Treatment (Week 24)

Measure: Number of Participants With HCV RNA < LLOQ Target Detected or Not Detected at the End of Treatment (Week 24)

Time: Week 24 (End-of Treatment)

Description: VR was defined as HCV RNA < LLOQ, target detected or not detected at specific time points (Week 4 and Week 12)

Measure: Number of Participants With Virologic Response (VR) at Treatment Week 4 and 12

Time: Treatment Week 4 and 12

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 rs12979860

An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.. Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24.



HPO Nodes


HPO:
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