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

A I Tukach; Тукач Артем Игоревич; S B Fitilev; Фитилев Сергей Борисович; I I Shkrebniova; Шкребнева Ирина Ивановна; A V Vozzhaev; Возжаев Александр Владимирович; V A Yakushev; Якушев Вадим Александрович; R A Ivanov; Иванов Роман Алексеевич; Yu N Lin’kova; Линькова Юлия Николаевна; T V Chernovskaya; Черновская Татьяна Вениаминовна

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

Authors: Tukach AI¹, Fitilev SB¹, Shkrebniova II¹, Vozzhaev AV¹, Yakushev VA¹, Ivanov RA², Lin’kova Y.N², Chernovskaya TV²
Affiliations:
1. Peoples’ Friendship University of Russia
2. «Biocad», Research and Development
Issue: No 2 (2014)
Pages: 114-118
Section: Articles
URL: https://journals.rudn.ru/medicine/article/view/2867

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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

hepatitis C, maximum tolerated dose, pegylated interferon-a, Cepeginterferon alfa-2b, safety profile, step by step dose escalation

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Vol 28, No 3 (2024): PHYSIOLOGY. EXPERIMENTAL PHYSIOLOGY

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

Full Text

Abstract

Keywords

About the authors

A I Tukach

S B Fitilev

I I Shkrebniova

A V Vozzhaev

V A Yakushev

R A Ivanov

Yu N Lin’kova

T V Chernovskaya

References

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