drugset / Trial / NCT02760355

Extrahepatic Insulin Resistance in Chronic Hepatitis C

NCT02760355

NaSingle-groupOpen-labelBasic science

Summary

In this pilot study, the investigators plan to treat patients with chronic hepatitis C due to HCV genotype 3 infection using an interferon-free regimen consisting in the administration of ribavirin and sofosbuvir/ledipasvir - a combination of a nucleotide RNA polymerase inhibitor with a non-structural protein 5A inhibitor. Patients will undergo a euglycemic hyperinsulinemic clamp, using tracers, and indirect calorimetry to assess whether the viral suppression induced by this regimen will be capable of reversing the glucose metabolic alterations induced by HCV in both the liver and extrahepatic compartments. Adipose and muscle tissue biopsies will also be performed to assess some specific molecular changes induced by HCV.

Timeline

Start
2016-03
Primary completion
2018-06-01
Completion
2018-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ledipasvir Small molecule 90 mg Oral
Subject Ribavirin Small molecule 1000 mg Oral
Subject Ribavirin Small molecule 1200 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral

Indications

No indication recorded.