At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 150 enrolled
Drug / intervention
Algeron +2 moredrug
Likely dose
Algeron 1.5 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Algeron, PegIntron, and 1 other intervention for Hepatitis and Hepatitis C. Completed, enrolled 150 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis, Hepatitis C
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
Primary CompletionJul 2012
First PostedDec 2012
Study CompletionDec 2013
TodayJul 2026
First PostedDec 4, 2012
Enrollment StartNov 1, 2011
Primary CompletionJul 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.6 years ago
Interventions
Algerondrug
1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
PegIntrondrug
1.5 μg/kg/week subcutaneously in combination with ribavirin
Ribavirindrug
800-1400 mg/day orally