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Dose Finding and Early Efficacy Study of Erlotinib in Treatment of Chronic Hepatitis C Virus infection_proof of Concept Study


Phase 1/Phase 2
18 Years
65 Years
Not Enrolling
Both
Chronic Hepatitis C Infection, HCV Genotype 1b

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Trial Information

Dose Finding and Early Efficacy Study of Erlotinib in Treatment of Chronic Hepatitis C Virus infection_proof of Concept Study


Inclusion Criteria:



- 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 Criteria:

- HIV or HBV infection

- Cirrhosis or Liver decompensation

- Chronic liver disease non related to HCV

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Assessment of virologic response and short-term safety of Erlotinib in patients infected with HCV genotype 1b

Outcome Description:

Determination of the recommended dose on the end point of dise-limiting toxicity (DLT), establishment of the maximum-tolerated dose (MTD), and response rate defined as a reduction of at least 1 log10 HCV RNA Levels after the last dose of study drug.

Outcome Time Frame:

14-day assessment study

Safety Issue:

Yes

Principal Investigator

Dr Samira Fafi-Kremer, Pharma D, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Laboratoire de Virologie PTM- Nouvel Hôpital CivilHôpitaux Universitaires de Strasbourg

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

AAP RCT 2012 N° HUS 5189

NCT ID:

NCT01835938

Start Date:

May 2013

Completion Date:

May 2015

Related Keywords:

  • Chronic Hepatitis C Infection
  • HCV Genotype 1b
  • Hepatitis C Virus infection
  • entry inhibitor
  • kinase inhibitor
  • Hepatitis
  • Hepatitis A
  • Hepatitis, Chronic
  • Hepatitis C
  • Hepatitis C, Chronic

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