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Report for Clinical Trial NCT01718158
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)
The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin
NCT01718158 Hepatitis C MeSH:Hepatitis C Hepatitis
HPO:Hepatitis
5 Interventions
Name: Peginterferon Lambda-1a
Name: Peginterferon Alfa-2a
Name: Ribavirin
Name: Daclatasvir
Name: Telaprevir
Primary Outcomes
Measure: Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12) Time: Post treatment follow-up Week 12Secondary Outcomes
Measure: Proportion of subjects who achieve SVR12 in treatment-naive subjects Time: Post treatment follow-up Week 12Measure: Proportion of subjects with rash related dermatologic events Time: Up to 12 weeks of treatment
Description: Treatment emergent cytopenic abnormalities [anemia as defined by Hemoglobin (Hb) < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750/mm3, and or thrombocytopenia as defined by platelets < 50,000/mm3]
Measure: Proportion of subjects who develop treatment emergent cytopenic abnormalities Time: Up to 48 WeeksMeasure: Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms Time: Up to 48 Weeks
Description: SVR24 = Sustained virologic response at post treatment follow-up Week 24
Measure: Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24 Time: Post treatment follow-up Week 24Measure: Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up Time: Maximum of 72 weeks
Measure: Proportion of subjects who achieve SVR12 with a 24-week treatment regimen Time: Post treatment follow-up Week 12
Measure: Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment) Time: Weeks 4 and 12 of treatment
Measure: Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up Time: Maximum of 72 weeks
Measure: Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT) Time: Maximum of 72 weeks
Description: Psychiatric symptoms (depression, irritability or insomnia)
Measure: Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT Time: Maximum of 48 weeksDescription: For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen
Measure: Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses Time: Post-treatment follow-up Week 12Measure: Resistant variants associated with virologic failure through end of follow-up Time: Maximum of 72 weeks
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs12979860
Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses.