MedTrace Logo

An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and and PegIntron (Peginterferon Alfa-2b) in Combination With Ribavirin as Combined Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients

NCT02103439 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-08-09

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1 infected patients

Conditions

  • Hepatitis
  • Hepatitis C
  • Hepatitis C/ Human Immunodeficiency Virus Coinfection

Interventions

DRUG

Algeron

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

DRUG

PegIntron

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

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Gregory Moshkovich, M.D. · State Institution of Nizhny Novgorod region "Regional Center for Prevention and Control of AIDS and other infectious diseases"

  • Firaya Nagimova, PhD · State Public Healthcare Institution National Center for the Prevention and Control of AIDS and other infectious diseases of the Ministry of Health of the Republic of Tatarstan

  • Oleg Kozyrev, PhD · State Healthcare Institution "Volgograd Regional Center for the Prevention and Control of AIDS and infectious diseases"

  • Andrey Shuldyakov, M.D., PhD · State Budgetary Higher Vocational Education Institution V.I. Razumovsky Saratov State University of medicine

  • Vadim Rassokhin, PhD · State Healthcare Institution Center for the Prevention and Control of AIDS and infectious diseases of the city, St.Petersburg CityHealth Department

  • Lidia Sklar, M.D., PhD · State Budgetary Higher Vocational Education Institution Pacific State Medical University, Ministry of Health of the Russian Federation

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
2013-06-06
Primary Completion
2015-08-26
Completion
2015-08-26

Countries

  • Russia

Study Locations

More Related Trials

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 NCT02103439 on ClinicalTrials.gov