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Report for Clinical Trial NCT01389323

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

NCT01389323 Hepatitis C
MeSH:Hepatitis A Hepatitis C Hepatitis
HPO:Hepatitis

3 Interventions

Name: Daclatasvir

Description: Tablet, Oral, 60 mg, once daily, 24 weeks
Type: Drug
Group Labels: 1

Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin

Name: Peg-Interferon Alfa-2a

Description: Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response
Type: Drug
Group Labels: 1

Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin

Name: Ribavirin

Description: Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response
Type: Drug
Group Labels: 1

Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin


Primary Outcomes

Description: SVR12 was defined as Hepatitis C Virus (HCV) RNA levels Measure: Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)

Time: Post-treatment Week 12

Secondary Outcomes

Description: SVR12 was defined as Hepatitis C Virus (HCV) RNA levels Measure: Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene

Time: Post-treatment Week 12

Description: The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels Measure: Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Time: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24


Description: The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.

Measure: Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels Time: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24

Description: An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.

Measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died

Time: From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 rs12979860

Some participants were represented in more than one race/ethnicity cohort.. Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene.



HPO Nodes


HPO: