Some safety aspects of a new russian pegylated interferon-A medication “ALGERON” (phase 1 clinical trial)

Abstract

Treatment of hepatitis C is one of the most acute international healthcare problems. High standard in management of patients with HCV virus is combined therapy with pegylated interferon-a plus ribavirin. A necessity to develop new medications and to improve current treatment regiments is determined by high social and economic significance of this disease. Safety and tolerance assessment in healthy volunteers, definition of maximum tolerated dose are conducted in first phase clinical trial of original, Russian medication - pegylated interferon-a, named Algeron (INN - Cepeginterferon alfa-2b). Step by step dose escalation of Algeron in groups of several healthy volunteers was applied in this trial. Results of this trial demonstrated, that safety profile of Algeron has no significant differences with safety profiles of analogical pegylated interferon-a medications. Thus Algeron can be recommended for the second phase clinical trials.

Keywords

• пегилированный интерферон альфа
• цепэгинтерферон альфа-2b
• переносимость
• побочные реакции