Exploring the Relationship Between Insulin Resistance and Interferon Resistance: Options to Overcome HCV Non-Response to Pegylated Interferon - The Relationship Between Insulin Resistance and Interferon resistance

Phase 1

• Conditions: HCV infected patient who do not response to Pegylated Interferon. This study is trying to explore the relationship between insulin resistance and Interferon Resistance and the possible rule of Pioglitazone treatment to improve Interferon sensetivity.

• Registration Number: EUCTR2009-016678-34-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-12-01
• Study Start: 2010-03-17
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1.Chronic HCV genotype 1 infection
2.Chronic HCV and compensated liver cirrhosis who failed to respond to previous treatment.
2.Age >17, <70
3.Eligible for interferon therapy

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.HIV or HBV co-infection.
2.Current use antidiabetic medication (eg insulin, metformin or thiazolidinedione).
3.Significant respiratory, cardiac or renal dysfunction
4.Body Mass Index > 30 kg/m2
5. Patients with manifestations of hepatic impairment in form of hepatic decompensation. This include any patient with:
?Clinically: history of ascites, jaundice, hepatic encephalopathy or bleeding oesophageal varices
?Laboratory: prolonged prothrombin time, low albumin level (<33 g/l) or high billirubin level.
?Imaging: evidence of ascites by abdominal ultrasound

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified