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

Phase 2 Completed 59 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.

Timeline

Start: 2009-09
Primary completion: 2011-04
Completion: —

Publications

Results Lawitz E, Godofsky E, Rouzier R, Marbury T, Nguyen T, Ke J, Huang M, Praestgaard J, Serra D, Evans TG. Safety, pharmacokinetics, and antiviral activity of the cyclophilin inhibitor NIM811 alone or in combination with pegylated interferon in HCV-infected patients receiving 14 days of therapy. Antiviral Res. 2011 Mar;89(3):238-45. doi: 10.1016/j.antiviral.2011.01.003. Epub 2011 Jan 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NIM811	Protein / enzyme biologic	—	Oral
Background	Peg-IFN	Protein / enzyme biologic	—	—
Background	RBV	Unknown	—	—

Indications

No indication recorded.