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

COMPLETEDPHASE3

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

An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and Ribavirin With Pegasys (Peginterferon Alfa-2a) and Ribavirin for Treatment of Patients With Chronic Hepatitis C

NCT01889433•Biocad

View on ClinicalTrials.gov

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.

Detailed Description

The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of rapid (after the 4th week) and early (after the 12th week) virologic response will be based on PCR data. For patients with treatment failure after the 12th week the antiviral therapy shall be discontinued. All patients who require further anti-viral treatment will receive a combination treatment with Algeron / Pegasys and ribavirin for another 12 or 36 weeks (depending on the HCV genotype). Sustained virologic response will be assessed 24 weeks after last dose of study treatment.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent to participate in the study.
•2. Chronic HCV infection (genotypes 1а, 1b, 2, 3, 4) with detectable HCV RNA \>6 month before the screening visit or abnormal ALT levels for \>6 month before the screening visit.
•3. Male and female patients, 18 to 70 years of age, inclusive.
•4. Body mass index of 18 - 30 kg/m2.
•5. Preserved protein synthetic liver function (INR \< 1.7, albumin \> 35 g/l).
•6. No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination.
•7. Fertile patients and their partners agree to use barrier contraception throughout the study treatment and 7 months after it.
•8. Patient must have documentation of fibroscan within 1 year before the screening visit or agree to have a fibroscan within the screening period.

Exclusion Criteria

•1. Intolerance to IFN alfa, ribavirin or any components of this preparations confirmed by past medical history.
•2. Infection by hepatitis B, A, E virus or HIV (co-infection).
•3. Any other documented significant liver disease (drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, biliary cirrohosis, etc.).
•4. Past history of HCV treatment with IFN alfa or pegylated IFN alfa.
•5. Administration of injectable and non-injectable interferons and/or some interferon inducers for any indication (other than HCV) for one month before enrollment into the study.
•6. Cholestatic hepatitis (level of conjugated bilirubin, alkaline phosphatase, G-GTP exceeding the upper normal level by more than 5 times).
•7. Decompensated liver cirrhosis confirmed by laboratory findings (class B, С according to Child-Pugh) or ultrasound examination.
•8. Any documented autoimmune diseases (e.g., Crohn's disease, ulcerative colitis, systemic lupus erythematosus, idiopathic thrombocytopenic purpura, scleroderma, autoimmune haemolytic anemia, severe psoriasis).
•9. Hemoglobin not lower than low normal level; neutrophils \< 1.5 х109/L; platelets \< 90 х109/L; creatinin level exceeding the upper normal level by more than 1.5 times, ALT level exceeding the upper normal level by more than 10 times.
•10. Documented hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
+11 more criteria

Locations (19)

Gomel Regional Clinical Hospital

Homyel, Belarus

Vitebsk Regional Clinical Hospital

Vitebsk, Belarus

Suyash Hospital Pvt. Ltd. Opposite M.G.M Medical College A.B. Road

Indore, India

M V Hospital & Research Center

Lucknow, India

Bhatia Hospital, Medical Research Society Tardeo Road, Grant Road (W)

Mumbai, India

Medipoint Hospitals Pvt. Ltd.

Pune, India

State Budgetary Higher Vocational Education Institution A.I. Evdokimov Moscow State University of Medicine and Dentistry

Moscow, Russia

State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

Moscow, Russia

State Public Healthcare Institution of the City of Moscow "Infectious Disease Clinical Hospital No. 1"

Moscow, Russia

Federal State Budgetary Institution Research Institute of Influenza

Saint Petersburg, Russia

Key Dates

Start Date

July 10, 2013

Primary Completion Date

December 2, 2015

Completion Date

December 2, 2015

Last Updated

July 16, 2018

Enrollment

170

ACTUAL participants

Conditions

HepatitisHepatitis C

Interventions

Algeron

DRUG

Pegasys

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

ePro Diary - HDV ( MACROLIVER )

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Identification of Liver Fibrosis Biomarkers