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Clinical Trials/EUCTR2009-016678-34-GB
EUCTR2009-016678-34-GB
Active, not recruiting
Phase 1

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

Imperial College London0 sites22 target enrollmentMarch 17, 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Imperial College London
Enrollment
22
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 17, 2010
End Date
December 1, 2009
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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