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Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C

NCT01740089 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-08-18

Study results available
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Summary

The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.

Conditions

  • Hepatitis
  • Hepatitis C

Interventions

DRUG

Algeron

1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously

DRUG

PegIntron

1.5 μg/kg/week subcutaneously in combination with ribavirin

DRUG

Ribavirin

800-1400 mg/day orally

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Olga Znoyko, professor · Moscow State University of Medicine and Dentistry

  • Marina Maevskaya, professor · The First Moscow State Sechenov Medical University

  • Svetlana Kizhlo · Health Department "Center for Prevention and Control of AIDS and Infectious Diseases"

  • Natalia Petrochenkova · Smolensk State Medical Academy

  • Semen Maximov · Moscow State University of Medicine and Dentistry

  • Firaja Nagimova · Kazan State Medical University

  • Vladimur Yakovlev · 7. St. Petersburg State Institution of Health "Clinical Infectious Diseases Hospital named SP Botkin"

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
2011-11-30
Primary Completion
2012-07-31
Completion
2013-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01740089 on ClinicalTrials.gov