An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C

Summary

The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.

Conditions

• Hepatitis
• Hepatitis C

Interventions

DRUG

Algeron

1.5 µg/kg of body weight subcutaneously, once a week

DRUG

Pegasys

180 µg subcutaneously, once a week

Sponsors & Collaborators

• Biocad

  lead INDUSTRY

Principal Investigators

• Konstantin Zhdanov, Professor · Federal State Military Higher Vocational Education Institution S.M. Kirov Military Medical Academy

• Olga Znoyko, Professor · State Budgetary Higher Vocational Education Institution A.I. Evdokimov Moscow State University of Medicine and Dentistry

• Marina Maevskaya, Professor · State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

• Vjacheslav Morozov · LLC Medical Company "Hepatolog", Samara, Russia

• Natalja Mironova, PhD · Municipal Healthcare Institution City Clinical Hospital No.2 named after V.I. Razumovsky, Healthcare Committee at the Administration of "Saratov City" Municipal District

• Elena Nurmuhametova, PhD · State Public Healthcare Institution of the City of Moscow "Infectious Disease Clinical Hospital No. 1", Moscow City Health Department

• Victor Pasechnikov, Professor · State Budgetary Higher Vocational Education Institution Stavropol State Medical Academy, Ministry of Health of the Russian Federation

• Natalia Petrochenkova, PhD · State Budgetary Higher Vocational Education Institution Smolensk State Medical Academy

• Tamara Sologub, Professor · Federal State Budgetary Institution Research Institute of Influenza, Ministry of Health of the Russian Federation, Saint-Petersburg

• Vladimir Rafalskiy, Professor · Regional State Healthcare Institution "Smolensk Regional Clinical Hospital"

• Evgeniy Chesnokov, Professor · State Medical and Preventive Institution of the Tyumen Region "Advisory and Diagnostic Center", Tyumen

• Sandeep Gupta, Dr · M V Hospital & Research Center, 314/30 Mirza Mandi, Chowk 226003, Lucknow 226003, Uttar Pradesh, India

• Tariq A Patil, Dr · Bhatia Hospital, Medical Research Society Tardeo Road, Grant Road (W), Maharashtra, India

• Mandar Doiphode, Dr · Medipoint Hospitals Pvt. Ltd. Maharashtra, India

• G S Malpani, Dr · Suyash Hospital Pvt. Ltd. Opposite M.G.M Medical College A.B. Road, Madhya Pradesh, India

• Tawesak Tanwandee · Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Siriraj Hospital, Bangkoknoi, Bangkok, Thailand

• Thongsawat Satawat · Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Sriphum, Muang, Chiang Mai, Thailand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-10

Primary Completion

2015-12-02

Completion

2015-12-02

Countries

• Belarus
• India
• Russia
• Thailand

Study Locations