Dose Finding and Early Efficacy Study of Erlotinib in Treatment of Chronic Hepatitis C Virus infection_proof of Concept Study
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Assessment of virologic response and short-term safety of Erlotinib in patients infected with HCV genotype 1b
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.
14-day assessment study
Yes
Dr Samira Fafi-Kremer, Pharma D, PhD
Study Director
Laboratoire de Virologie PTM- Nouvel Hôpital CivilHôpitaux Universitaires de Strasbourg
France: Agence Nationale de Sécurité du Médicament et des produits de santé
AAP RCT 2012 N° HUS 5189
NCT01835938
May 2013
May 2015
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