NCT00983060 - Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

April 30, 2011

Conditions

Chronic Hepatitis C Genotype-1 Relapse

Interventions

DRUG

NIM811

BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)

DRUG

Placebo BID + SOC

Placebo BID + SOC (PEG IFN and RBV)

Trial Locations (16)

Novartis Investigative Site, Leuven

Orlando Clinical Research Center, Orlando

West Wind'r Research & Development LLC, Tampa

University Hepatitis Center, Sarasota

Alamo Medical Research, San Antonio

Research and Education Inc., San Diego

Novartis Investigative Site, Clayton

Novartis Investigative Site, Westmead

Novartis Investigative Site, Wentworthville

Novartis Investigative Site, Brussels

Novartis Investigative Site, Frankfurt

Novartis Investigative Site, Barcelona

Novartis Investigative Site, Seville

Novartis Investigative Site, Taipei

Novartis Investigative Site, Kaohsiung City

Fundacion de Investigacion de Diego, San Juan