Overview

Extrahepatic Insulin Resistance in Chronic Hepatitis C

Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Geneva
Collaborators:
Clément Sophie
Gastaldi Giacomo
Treatments:
Ledipasvir
Ribavirin
Sofosbuvir
Criteria
Inclusion Criteria:

- Histologically confirmed chronic hepatitis C with HCV genotype 3a infection,

- Adult Caucasian patient males or non-pregnant or non-lactating females, aged 18 to 65
at the time of the screening;

- Informed Consent as documented by signature;

- Lack of contraindications to the class of drugs under study, e.g. known
hypersensitivity or allergy to class of drugs or the investigational products.

Exclusion Criteria:

- Cirrhosis;

- Excess active alcohol consumption (>30 g/day in males, >20 g/day in females);

- Active illicit drug use.

- Coinfection with HIV or hepatitis B virus;

- Concomitant medications with clinically significant interactions with the study drugs;

- Women who are pregnant or breast feeding or who intend to become pregnant during the
course of the study;

- Lack of safe contraception, defined as: female participants of childbearing potential,
not using and not willing to continue using a medically reliable method of
contraception for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices, or who are not using any other
method considered sufficiently reliable by the investigator in individual cases;

- Other clinically significant concomitant disease states (e.g., renal failure, hepatic
dysfunction, cardiovascular disease, etc.);

- Known or suspected non-compliance;

- Inability to follow the procedures of the study, including, but not limited to,
language problems, psychological disorders, dementia;

- Participation in another study with any investigational drug within the 30 days
preceding and during the present study;

- Enrolment of the investigator, his/her family members, employees and other dependent
persons.