Status:

UNKNOWN

Clinical Investigation of Erlotinib as an HCV Entry Inhibitor

Lead Sponsor:

University Hospital, Strasbourg, France

Conditions:

Chronic Hepatitis C Infection

HCV Genotype 1b

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

PHASE2

Brief Summary

Chronic Hepatitis C Virus (HCV) infection is a major cause of liver cirrhosis and hepatocellular carcinoma world-wide. Current combination therapy of pegylated interferon-alfa, ribavirin and protease ...

Eligibility Criteria

Inclusion

  • Chronic genotype 1b hepatitis C infection with detectable HCV RNA (\> 1x104 UI/mL)
  • Naïve, relapser or non-responder to interferon with or without ribavirin
  • Weight \> 45kg, BMI between 18 and 25 Kg/m2 who had a liver biopsy or liver FibroScan eliminating the presence of cirrhosis in the year before enrollment,
  • Non-smoker or occasional smoker ( ie \< 3 cig/day)

Exclusion

  • HIV or HBV infection
  • Cirrhosis or Liver decompensation
  • Chronic liver disease non related to HCV

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2015

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT01835938

Start Date

May 1 2013

End Date

May 1 2015

Last Update

June 17 2014

Active Locations (1)

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1

Service d'Hépatogastroentérologie, NHC1, place de l'hôpital

Strasbourg, Alsace, France, BP n°426