SNPMiner Trials (Home Page)
Report for Mutation L31F
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.
NCT02580474 Hepatitis C Drug: Daclatasvir plus Asunaprevir MeSH:Hepatitis C Renal Insufficiency Kidney Failure, Chronic
HPO:Renal insufficiency
Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening - No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H Exclusion Criteria: - A patient who having received Daclatasvir or Asunaprevir - Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study - Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV - Diagnosed or suspected hepatocellular carcinoma or other malignancies - Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage) - Received solid organ or bone marrow transplant - Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance - Significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator - Known hypersensitivity to study drugs, metabolites, or formulation excipients - Who has taken investigational drugs within 2 months. --- L31F ---
Primary Outcomes
Measure: the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment Time: 36 WeekSecondary Outcomes
Measure: To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment Time: 36 WeekMeasure: Percentage of subjects with ALT normalization at each visit from the baseline Time: 4, 12, 24, 36 week
Measure: Change in HCV RNA at each visit from the baseline Time: 4, 12, 24, 36 week
Measure: Percentage of subjects who experience viral breakthrough at each visit from the baseline Time: 4, 12, 24, 36 week
Measure: Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from Time: 4, 12, 24, 36 week
2 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 Drug: daclatasvir Drug: asunaprevir Drug: Ribavirin MeSH:Hepatitis C
The existence of baseline NS5A RAV "Lycine 31 (L31F/I/M)" or "Tyrosine93 (Y93H)", by using direct-sequencing with RAV of > 20%. --- L31F ---
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