Clinical Trials

Date: 2012-03-13

Type of information: Treatment of the first patient

phase: 3

Announcement: treatment of the first patient

Company: Tibotec Pharmaceuticals-J&J (Ireland - USA) Medivir (Sweden)

Product: simeprevir (TMC435)

Action mechanism:

direct-acting antiviral agent/protease inhibitor/RNA polymerase (NS3A) inhibitor. Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir.

Disease: hepatitis C genotype-1 infected patients who were null or partial responders to prior PegINF/RBV therapy

Therapeutic area: Infectious diseases

Country:

Trial details:

HPC3001 is a phase III efficacy, safety and tolerability study comparing TMC435 versus telaprevir, each in combination with Pegylated Interferon alpha-2a (PegINF) and ribavirin (RBV), in hepatitis C genotype-1 infected patients who were null or partial responders to prior PegINF/RBV therapy. The study which is a randomized, double-blind, double-dummy, two-arm study is targeted to enroll 744 patients. The aim of the study is to demonstrate the efficacy of TMC435 based therapy compared to the approved telaprevir regimen in this difficult to treat population. Patients will receive TMC435 150 mg once daily or telaprevir 750 mg administered every eight hours (q8h) in combination with PegINF/RBV for 12 weeks followed by 36 weeks of PegIFN/RBV alone. The primary endpoint of the study is sustained virological response at 12 weeks (SVR12).

Latest news:

Medivir has announced that its oral, once daily investigational protease inhibitor TMC435, developed by Janssen Pharmaceuticals for the treatment of Hepatitis C virus (HCV), has commenced patient dosing and started screening in two new phase III clinical trials, HPC3001 and HPC3011, respectively. The Ongoing global phase III program in brief is : •TMC435-C208 or QUEST-1 in 375 treatment-naïve genotype-1 patients •TMC435-C216 or QUEST-2 in 375 treatment-naïve genotype-1 patients •TMC435-C3007 or PROMISE in 375 genotype-1 patients who have relapsed after prior interferon-based treatment. •Phase III program in Japan, includes 417 genotype-1 treatment naïve and treatment experienced patients