NCT01835938

Clinical Investigation of Erlotinib as an HCV Entry Inhibitor

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 inhibitors is limited by resistance and substantial side effects. The investigators identified epidermal growth factor receptor (EGFR) as host factor for HCV infection. Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM) broadly inhibits HCV infection of all major genotypes including viral escape variants resistant to host immune responses. Completed preclinical proof-of-concept studies in HCV cell culture and animal model systems demonstrate that inhibition of EGFR function by Erlotinib constitutes a novel antiviral approach for prevention and treatment of HCV infection (European patent application EP 08 305 604.4, Filing date: September 26, 2008; Inserm, Paris, France and Lupberger et al. Nature Medicine 2011). Since Erlotinib (TarcevaTM) is an established approved drug for cancer treatment and has a well characterized safety profile in humans, the aim of the study is to investigate the safety, efficacy and pharmacokinetics of Erlotinib, a first-in-class entry inhibitor, for treatment of HCV infection in a randomized placebo-controlled double blind clinical trial in patients chronically infected with HCV. Following completion, this trial will set the stage for a further investigation of entry inhibitors as antivirals in combination with standard of care or direct antivirals such as HCV protease inhibitors. Thus, this randomized clinical trial will be an important step in the development of novel urgently needed antiviral therapies overcoming resistance.

Conditions

• Chronic Hepatitis C Infection
• HCV Genotype 1b

Interventions

Type	Name	Description
DRUG	1- Erlotinib	* Erlotinib 50 mg tablet by mouth every day for 14 days, * Erlotinib 100 mg tablet by mouth every day for 14 days, * Erlotinib 150 mg tablet by mouth every day for 14 days,
DRUG	placebo	* Placebo 50 mg tablet by mouth every day for 14 days, * Placebo 100 mg tablet by mouth every day for 14 days, * Placebo 150 mg tablet by mouth every day for 14 days,

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-04-19
• Last updated: 2014-06-17

Locations

1 site across 1 country: France