At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓HCV RNA ≥100,000 IU/mL at screening
- ✓Chronic HCV infection ≥6 months, genotype 1b only, documented by prior medical history or liver biopsy
- ✓Treatment-naïve: no prior exposure to interferon, ribavirin, or any HCV-specific DAA (approved or experimental)
- ✕History of hepatic decompensation (ascites, encephalopathy, variceal hemorrhage)
- ✕Chronic liver disease of non-HCV etiology (hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis, NASH, autoimmune hepatitis)
- ✕HBV or HIV co-infection
- ✕Malignancy within 5 years prior to screening (except surgically cured skin cancer)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis
In Brief
A Phase 3 clinical trial evaluating Elbasvir/Grazoprevir Fixed Dose Combination for Chronic HCV Infection. Completed, enrolled 117 participants across 1 site.
Detailed Summary
A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis The primary objectives of this study are as follows: * To evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12). * To evaluate the safety and tolerability of EBV/GZR treatment The secondary objectives of this study are as follows: * To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24) * To evaluate the proportion of subjects with virologic failure * To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment. * To evaluate the emergence of viral resistance to EBV/GZR during treatment and after cessation of treatment
Study Details
Timeline
Interventions
Evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).