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Report for Clinical Trial NCT01995266
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
A Phase 3, Open-Label Study With Daclatasvir And Asunaprevir (DUAL) for Subjects With Genotype 1b Chronic Hepatitis C (HCV) Infection Who Are Intolerant or Ineligible to Interferon Alfa Therapies With or Without Ribavirin
Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen
NCT01995266 Hepatitis C MeSH:Hepatitis C Hepatitis
HPO:Hepatitis
2 Interventions
Name: Asunaprevir
Name: Daclatasvir
Primary Outcomes
Description: SVR 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 24.
Measure: Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24) Time: 24 Weeks after treatment discontinuation (Follow-up Week 24)Secondary Outcomes
Description: SVR12 was defined as HCV RNA < LLOQ target detected or not detected at post-treatment follow-up Week 12. For SVR12, missing HCV RNA data at follow-up Week 12 was imputed using the Next Value Carried Backwards (NVCB) approach.
Measure: Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12) Time: 12 Weeks after treatment discontinuation (Follow-up Week 12)Description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.
Measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Death, and AEs Leading to Discontinuation Time: 7 days after treatment discontinuationDescription: Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 24.
Measure: Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24 Time: 24 Weeks after treatment discontinuation (Follow-up Week 24)Description: Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0. The lower and upper limits of quantitation (LOQs) of the assay for HCV GT-1 were 25 IU/mL and 3.91 X10^8 IU/mL, respectively; the limit of detection was ~ 10 IU/mL
Measure: Percentage of Participants With HCV RNA< LLOQ Target Not Detected at the End of Treatment (Week 24) Time: Week 24 (End-of Treatment)Description: RVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 4.
Measure: Number of Participants With Rapid Virologic Response (RVR) Time: Treatment Week 4Description: cEVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 12.
Measure: Percentage of Participants With Complete Early Virologic Response (cEVR) Time: Treatment Week 12Description: eRVR was defined as HCV RNA < LLOQ, target not detected at treatment Weeks 4 and 12.
Measure: Number of Participants With Extended Rapid Virologic Response (eRVR) Time: Treatment Week 4 and Week 12Description: Antiviral efficacy is measured by the number of participants with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at End of Treatment (Week 24)
Measure: Number of Participants With HCV RNA < LLOQ Target Detected or Not Detected at the End of Treatment (Week 24) Time: Week 24 (End-of Treatment)Description: VR was defined as HCV RNA < LLOQ, target detected or not detected at specific time points (Week 4 and Week 12)
Measure: Number of Participants With Virologic Response (VR) at Treatment Week 4 and 12 Time: Treatment Week 4 and 12Purpose: Treatment
Allocation: N/A
Single Group Assignment
There is one SNP
SNPs
1 rs12979860
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.. Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24.