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Extrahepatic Insulin Resistance in Chronic Hepatitis C

NCT02760355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-05-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ledipasvir 90 mg/Sofosbuvir 400 mg

Oral administration on one fixed dose combination tablet for 12 weeks

DRUG

Ribavirin

Oral administration of body weight-dose adjusted, 200 mg-tablets of ribavirin (1,000 mg in two administration in patients \<75 Kg of body weight, or 1,200 mg in two administrations for those \>75 Kg) for 12 weeks.

Sponsors & Collaborators

  • Gastaldi Giacomo

    collaborator UNKNOWN

  • Clément Sophie

    collaborator UNKNOWN

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Francesco Negro, MD · University Hospitals of Geneva

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02760355 on ClinicalTrials.gov