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Trials scheduled for hepatitis C protease inhibitor

Phase IIa clinical trials of a hepatitis C protease inhibitor are about to launch at test centres across Europe, it has been announced.

Medivir said that four dose regimens of TMC435350 would be examined by researchers at 20 centres, with the effectiveness, safety and tolerability of the drug also being investigated.

A total of 120 patients with chronic genotype-1 hepatitis C, a blood-borne virus which can cause serious damage to the liver of an infected patient, will be enrolled in the study, including 96 people the firm describes as "treatment-naive" and 24 who have already received treatment.

Each of them will be given either a daily dose of TMC435350 or a placebo for 28 days.

The firm added it would provide standard of care treatment (Soc)– made up of peginterferon alpha-2a and ribavirin for 48 weeks or 24 weeks, depending on the viral load of the patient.

"Patients will be followed-up for 24 weeks after the end of SoC to allow evaluation of sustained virologic response," Medivir explained in a statement.

Healthcare providers who need to obtain drugs undergoing clinical trials for a patient can contact Masters, which has a comprehensive named patient supply programme capable of sourcing drugs from a variety of suppliers.ADNFCR-1276-ID-18366137-ADNFCR