SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation Y93F

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
Conditions
  1. Hepatitis C Virus
Interventions
  1. Drug: BMS-790052
  2. Drug: BMS-790052
  3. Drug: Placebo
  4. Drug: peginterferon alfa-2a
  5. Drug: ribavirin
MeSH:Hepatitis C Hepatitis
HPO:Hepatitis

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.. Inclusion Criteria: - Subjects chronically infected with HCV genotype 1 - Non-responder to prior therapy with peginterferon alfa and ribavirin - HCV RNA viral load of 100,00 IU/mL - Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population) - Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma - Body Mass Index (BMI) of 18 to 35 kg/m2 Exclusion Criteria: - Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening - Evidence of medical condition associated with chronic liver disease other than HCV - Evidence of decompensated cirrhosis based on radiologic criteria or biopsy Inclusion Criteria: - Subjects chronically infected with HCV genotype 1 - Non-responder to prior therapy with peginterferon alfa and ribavirin - HCV RNA viral load of 100,00 IU/mL - Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population) - Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma - Body Mass Index (BMI) of 18 to 35 kg/m2 Exclusion Criteria: - Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening - Evidence of medical condition associated with chronic liver disease other than HCV - Evidence of decompensated cirrhosis based on radiologic criteria or biopsy Hepatitis C Virus Hepatitis C Hepatitis null --- L28M --- --- R30H --- --- L31M --- --- Q54H --- --- P58A --- --- Q62E --- --- A92T --- --- Y93F ---

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 12

Description: SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA Measure: Percentage of Participants With 24-week Sustained Virologic Response (SVR24)

Time: Follow-up Week 24

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 weeks

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) and Who Died During Follow-up Period

Time: From day 8 post last dose of treatment up-to Week 72

Secondary Outcomes

Description: RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Measure: Percentage of Participants With Rapid Virologic Response (RVR)

Time: Week 4

Description: cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Measure: Percentage of Participants With Complete Early Virologic Response (cEVR)

Time: Week 12

Description: SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA Measure: Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)

Time: Follow-up Week 12

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 48

Description: 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


HPO Nodes