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Report for Clinical Trial NCT03004625

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Treatment Efficacy and Safety of 12 Weeks of Daclatasvir, Asunaprevir Plus Ribavirin for HCV Genotype 1b Without Baseline NS5A Resistance-associated Variants (DARING)

A single-arm, multi-center study of HCV-1b patients without baseline non-structure protein (NS5A) resistance-associated variants. Daclatasvir (60mg/day) and asunaprevir (100 mg twice daily) plus weight-based ribavirin (1000-1200 mg/d) for 12 weeks will be prescribed.

NCT03004625 Hepatitis C
MeSH: Hepatitis C

3 Interventions

Name: daclatasvir

Description: to evaluate the treatment efficacy and safety of the drug in HCV patients

Type: Drug

Study Arm

Name: asunaprevir

Description: to evaluate the treatment efficacy and safety of the drug in HCV patients

Type: Drug

Study Arm

Name: Ribavirin

Description: to evaluate the treatment efficacy and safety of the drug in HCV patients

Type: Drug

Study Arm


Primary Outcomes

Description: SVR12 is defined as undetectable HCV RNA 12 weeks throughout 12 weeks of post-treatment follow-up peroid

Measure: To determine the treatment efficacy (SVR12) of 12 weeks of daclatasvir and asunaprevir plus ribavirin for HCV-1b patients without baseline RAVs

Time: 6 months (including 3 months of treatment and 3 months of post-treatment follow-up peroid

Secondary Outcomes

Measure: To evaluate the number of participants with treatment-related adverse events of 12 weeks of daclatasvir and asunaprevir plus ribavirin for HCV-1b patients without baseline RAVs.

Time: 3 months

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 L31F

The existence of baseline NS5A RAV "Lycine 31 (L31F/I/M)" or "Tyrosine93 (Y93H)", by using direct-sequencing with RAV of > 20%. --- L31F ---


2 Y93H

The existence of baseline NS5A RAV "Lycine 31 (L31F/I/M)" or "Tyrosine93 (Y93H)", by using direct-sequencing with RAV of > 20%. --- L31F --- --- Y93H ---



HPO Nodes