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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

Type: Drug
Group Labels: 3

Arm 1: DCV/ASV/BMS-791325+Sofosbuvir Arm 2: DCV/ASV/BMS-791325 + Sofosbuvir Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a

Name: Ribavirin

Type: Drug
Group Labels: 2

Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a

Name: Sofosbuvir

Type: Drug
Group Labels: 3

Arm 1: DCV/ASV/BMS-791325+Sofosbuvir Arm 2: DCV/ASV/BMS-791325 + Sofosbuvir Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a

Name: Peginterferon α-2a

Type: Drug
Group Labels: 2

Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-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 treatment

Description: 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 RNA Time: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)

Description: 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 24

Description: 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 12

Description: 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 12

Purpose: 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..



HPO Nodes


HPO: