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Study the Relationship Between Obesity and Hepatitis C Replication

NCT01157975 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-02

No results posted yet for this study

Summary

Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2 are refractory to medical treatment. Also, HCV replication seems to be affected when modeling insulin resistance in replicon cell culture systems.

PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity. Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase HCV viral kinetics. .

Conditions

  • Hepatitis C

Interventions

DRUG

Pioglitazone

Pioglitazone will be taken at a dose of 30 mg for up to 14 days

DRUG

Prednisone

Prednisone will be taken at a dose of 40 mg for up to 4 days

Sponsors & Collaborators

Principal Investigators

  • Mario Chojkier, MD · UCSD

  • Martina Buck, PhD · UCSD

  • Hesham Elkhayat, MD · Cairo University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2014-02-28
Completion
2014-09-30

Countries

  • United States
  • Egypt

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01157975 on ClinicalTrials.gov