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

Disease: Hepatitis C genotype-4 infected patients

Therapeutic area: Infectious diseases

Country:

Trial details:

HPC3011 is an open label, single arm phase III trial to explore the efficacy, safety and tolerability of TMC435 150 mg once daily, in combination with PegIFN/RBV in 100 treatment naïve or treatment experienced, Hepatitis C genotype-4 infected patients. Current standard of care treatment for chronic HCV genotype-4 infection consists of 48 weeks of PegIFN/RBV with a large proportion of patients do not achieve SVR with this treatment regimen. All subjects will receive 12 weeks triple therapy of TMC435 150 mg once daily and PegIFN/RBV, followed by PegIFN/RBV alone. The duration of total treatment is response guided in treatment naïve and prior relapser subjects and patients are eligible to stop all treatment at week 24 if predefined response-guided criteria are met. Subjects with cirrhosis will receive 48 weeks of therapy, irrespective of on-treatment virologic response and treatment history. The primary endpoint in the study is SVR12.

Latest news:

Medivir has announced new studies in phase III program for TMC435. 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.