Trials / Completed
CompletedNCT02103439
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
Multicenter Open-label Randomized, Comparative Clinical Study to Evaluate Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b, CJSC "BIOCAD", Russia) With Ribavirin Compared to PegIntron (Peginterferon Alfa-2b, Schering-Plough Labo N.V., Belgium) With Ribavirin in Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (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 in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1 infected patients
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 polymerase chain reaction 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 / PegIntron and ribavirin for another 36 weeks. Sustained virologic response will be assessed 24 weeks after last dose of study treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-06-06
- Primary completion
- 2015-08-26
- Completion
- 2015-08-26
- First posted
- 2014-04-03
- Last updated
- 2018-08-09
- Results posted
- 2015-07-21
Locations
6 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT02103439. Inclusion in this directory is not an endorsement.