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Report for Clinical Trial NCT02175966
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis C (FOURward Study)
The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.
NCT02175966 Hepatitis C MeSH:Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis
HPO:Hepatitis
4 Interventions
Name: DCV/ASV/BMS-791325
Name: Ribavirin
Name: Sofosbuvir
Name: Peginterferon α-2a
Primary Outcomes
Description: SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach.
Measure: Percentage of Participants With Sustained Virologic Response 12 (SVR12) Time: 12 Weeks after treatment discontinuation (Follow-up Week 12)Description: SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.
Measure: Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment Time: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)Description: Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.
Measure: Number of Participants With Selected Grade 3/4 Laboratory Abnormalities Time: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)Secondary Outcomes
Description: EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment.
Measure: Percentage of Participants With End of Treatment Response (EOTR) Time: End of the treatmentDescription: Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24).
Measure: Percentage of Participants Who Achieved HCV RNADescription: Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24).
Measure: Percentage of Participants Who Achieved HCV RNA < LLOQ TND Time: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24Description: Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b
Measure: Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b Time: Post-treatment Week 12Description: Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
Measure: Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype) Time: Post-treatment Week 12Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs12979860
Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype).
Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported..