NCT01740089

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

Multicenter Open-label Randomized Prospective Clinical Study of Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b) in Comparison With PegIntron (Peginterferon Alfa-2b) in the Combined Treatment of Chronic Hepatitis C

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After 12 weeks of treatment, an assessment of treatment efficacy was performed, i.e. rates of rapid (after 4 weeks) and early (after 12 weeks) virologic responses according to serum HCV RNA level PCR data. In patients without virologic response after 12 weeks, AVT was discontinued, and they were withdrawn from the study. Patients with EVR were enrolled in a follow-up period. During the follow-up period, patients of the first and the second group will receive Algeron in the selected therapeutic dose in combination with ribavirin, patients of the third group - PegIntron in combination with ribavirin during 12 or 36 weeks (depending on a genotype of the virus), afterwards they will be followed up without therapy for 24 weeks.

Conditions

• Hepatitis
• Hepatitis C

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-07-01
• Completion: 2013-12-01
• First posted: 2012-12-04
• Last updated: 2015-08-18
• Results posted: 2015-08-18

Locations

1 site across 1 country: Russia