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 - Study Results

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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

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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.
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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

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

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1. Primary:

Early Virological Response [ Time Frame: 12 weeks ]

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2. Primary:

Early Virological Response in Patients With Different Hepatitis C Virus Genotypes [ Time Frame: 12 weeks ]

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3. Secondary:

Rapid Virological Response [ Time Frame: 4 weeks ]

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4. Secondary:

Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes [ Time Frame: 4 weeks ]

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5. Secondary:

Viral Breakthrough [ Time Frame: screening data and at 4 or 12 weeks of treatment. ]

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6. Secondary:

Biochemical Response [ Time Frame: 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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More Information

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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
Study First Received:	April 1, 2014
Results First Received:	May 21, 2015
Last Updated:	January 12, 2016