SNPMiner Trials (Home Page)
Report for Mutation M28L
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy
The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
NCT01170962 Hepatitis C Virus Drug: BMS-790052 Drug: BMS-790052 Drug: Placebo Drug: peginterferon alfa-2a Drug: ribavirin MeSH:Hepatitis C Hepatitis
HPO:Hepatitis
Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.. Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures. --- M28L ---
Primary Outcomes
Description: eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR) Time: Week 4, Week 12Description: SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA
Description: AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment Time: From first dose to last dose plus 7 days, up to 49 weeksDescription: AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Measure: Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period Time: From day 8 post last dose of treatment up-to Week 72Secondary Outcomes
Description: RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA
Description: cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA
Description: SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA
Description: Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.
Measure: Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures Time: Baseline to follow-up Week 48Description: Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.
Measure: Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures Time: Baseline to follow-up Week 48