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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

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ClinicalTrials.gov Identifier: NCT02103439
Recruitment Status : Unknown
Verified January 2016 by Biocad.
Recruitment status was:  Active, not recruiting
First Posted : April 3, 2014
Results First Posted : July 21, 2015
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hepatitis
Hepatitis C
Hepatitis C/ Human Immunodeficiency Virus Coinfection
Interventions: Drug: Algeron
Drug: PegIntron

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Algeron

Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)

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

PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).

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

Participant Flow:   Overall Study
    Algeron   PegIntron
STARTED   70   70 
COMPLETED   67   67 
NOT COMPLETED   3   3 
Adverse Event                0                2 
Withdrawal by Subject                3                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Algeron

Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)

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

PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).

PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week
Total Total of all reporting groups

Baseline Measures
   Algeron   PegIntron   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 70   70   140 
Age 
[Units: Years]
Median (Inter-Quartile Range) 		 33 
 (30 to 37)  		 34 
 (31 to 37)  		 33.5 
 (31 to 37) 
Gender 
[Units: Participants]
 		     
Female   25   24   49 
Male   45   46   91 
Race (NIH/OMB) 
[Units: Participants]
 		     
American Indian or Alaska Native   0   0   0 
Asian   2   1   3 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   68   69   137 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
 		     
Russian Federation   70   70   140 


  Outcome Measures

1.  Primary:   Early Virological Response   [ Time Frame: 12 weeks ]
  Show Outcome Measure 1

2.  Primary:   Early Virological Response in Patients With Different Hepatitis C Virus Genotypes   [ Time Frame: 12 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Rapid Virological Response   [ Time Frame: 4 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes   [ Time Frame: 4 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Viral Breakthrough   [ Time Frame: screening data and at 4 or 12 weeks of treatment. ]
  Show Outcome Measure 5

6.  Secondary:   Biochemical Response   [ Time Frame: 12 weeks ]
  Show Outcome Measure 6


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Yulia Linkova Medical Director
Organization: Biocad
phone: +7 (495) 992 66 28 ext 930
e-mail: linkova@biocad.ru



Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02103439     History of Changes
Other Study ID Numbers: BCD-016-4
First Submitted: April 1, 2014
First Posted: April 3, 2014
Results First Submitted: May 21, 2015
Results First Posted: July 21, 2015
Last Update Posted: February 8, 2016