SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation Y93C

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 2 clinical trials

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 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 --- --- Q30H --- --- L31M --- --- H54Y --- --- H58C --- --- E62D --- --- Y93C ---

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

2 Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study

Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study

NCT02762448
Conditions
  1. Hepatitis c
Interventions
  1. Drug: Daclatasvir+ Asunaprevir
MeSH:Hepatitis C Lymphoma, Non-Hodgkin
HPO:Non-Hodgkin lymphoma

An HCV RNA level of 105 IU per milliliter or higher 5. Being diagnosed to be low grade B cell non-Hodgkin lymphoma Exclusion Criteria: 1. Patients with hepatitis B virus infection, 2. Other liver diseases 3. HIV infection, 4. Pre-existing HCV variants in the NS5A domain included Q30R, L31 M/V, and Y93C/N 5. Evidence of cirrhosis, as documented by means of either liver biopsy or assessment of imaging results. --- Q30R --- --- Y93C ---

Primary Outcomes

Description: patients who had undetectable HCV RNA levels at or after week 4. Viral relapse was defined as confirmed detectable HCV RNA levels during the post-treatment follow-up period in patients who had had undetectable HCV RNA levels at the end of treatment

Measure: HCV clearance and complete regression of NHL by ASV+ DCV

Time: 2years


HPO Nodes