Health Condition 1: B182- Chronic viral hepatitis C
Conditions
Interventions
Intervention1: ESRD, full dose: Patients with end stage renal disease (estimated GFR below 30 ml/min) and hepatitis C virus infection and treated with sofosbuvir 400 mg on alternate days
Intervention2
Sponsors
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow India
Eligibility
Inclusion criteria
Inclusion criteria: Patients with (i) hepatitis C virus infection with detectable HCV RNA in blood (ii) naïve to direct acting antiviral drugs based anti-HCV treatment
Exclusion criteria
Exclusion criteria: 1. Hepatitis B virus co-infection 2. Human immunodeficiency virus co-infection 3. Clinical evidence of cirrhosis or portal hypertension such as ascites, esophageal or gastric varices on esophago-gastro-duodenoscopy, liver stiffness more than 15 KPa as measured with transient elastography or history of hepatic encephalopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the pharmacokinetics of sofosbuvir and its metabolite (GS-331007) in end-stage renal disease patients treated with low-dose of sofosbuvir and compare it with that in patients with normal renal function.Timepoint: At hour (from the time of drug administration) â??0â??, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 [D1], 36 [D2], 84 [D4], and 156 [D7] | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with sustained virologic response 12 weeks after discontinuation of anti-HCV treatment (SVR12)Timepoint: 12 weeks after stopping treatment | — |
Countries
India
Contacts
Public ContactAmit Goel
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI)
Outcome results
None listed