Trial Outcomes & Findings for 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 (NCT NCT02103439)

NCT ID: NCT02103439

Last Updated: 2018-08-09

Results Overview

Proportion of randomized patients achieving early virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (\< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 140 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-08-09

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	70	70
Overall Study COMPLETED	67	67
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	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
Overall Study Adverse Event	0	2
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Algeron n=70 Participants 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 n=70 Participants 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 n=140 Participants Total of all reporting groups
Age, Continuous	33 years n=5 Participants	34 years n=7 Participants	33.5 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	46 Participants n=7 Participants	91 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	69 Participants n=7 Participants	137 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Russian Federation	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Proportion of randomized patients achieving early virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment

Outcome measures

Measure	Algeron n=70 Participants 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 n=70 Participants 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	PegIntron - HCV-1 Patients with HCV genotype 1, received 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	PegIntron - HCV-2/3 Patients with HCV genotype 2 or 3, received 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
Early Virological Response	90.0 percentage of patients	81.4 percentage of patients	—	—

PRIMARY outcome

Timeframe: 12 weeks

Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving early virologic response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment

Outcome measures

Measure	Algeron n=34 Participants 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 n=36 Participants 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	PegIntron - HCV-1 n=33 Participants Patients with HCV genotype 1, received 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	PegIntron - HCV-2/3 n=37 Participants Patients with HCV genotype 2 or 3, received 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
Early Virological Response in Patients With Different Hepatitis C Virus Genotypes	82.4 percentage of patients	97.2 percentage of patients	75.8 percentage of patients	88.5 percentage of patients

SECONDARY outcome

Timeframe: 4 weeks

Proportion of randomized patients achieving rapid virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment

Outcome measures

Measure	Algeron n=70 Participants 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 n=70 Participants 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	PegIntron - HCV-1 Patients with HCV genotype 1, received 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	PegIntron - HCV-2/3 Patients with HCV genotype 2 or 3, received 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
Rapid Virological Response	51.4 percentage of patients	37.1 percentage of patients	—	—

SECONDARY outcome

Timeframe: 4 weeks

Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving rapid virological response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment

Outcome measures

Measure	Algeron n=34 Participants 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 n=36 Participants 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	PegIntron - HCV-1 n=33 Participants Patients with HCV genotype 1, received 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	PegIntron - HCV-2/3 n=37 Participants Patients with HCV genotype 2 or 3, received 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
Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes	23.5 percentage of patients	77.8 percentage of patients	21.2 percentage of patients	51.4 percentage of patients

SECONDARY outcome

Timeframe: screening data and at 4 or 12 weeks of treatment.

Proportion of patients in each groups with level of Hepatitis C Virus ribonucleic acid > 15 IU/ml after Hepatitis C Virus ribonucleic acid was not present or Hepatitis C Virus ribonucleic acid was increased by more than 1log10 from baseline at 4 or 12 weeks of treatment

Outcome measures

Measure	Algeron n=70 Participants 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 n=70 Participants 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	PegIntron - HCV-1 Patients with HCV genotype 1, received 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	PegIntron - HCV-2/3 Patients with HCV genotype 2 or 3, received 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
Viral Breakthrough	0 percentage of patients	0 percentage of patients	—	—

SECONDARY outcome

Timeframe: 12 weeks

Proportion of patients in each group with alanine aminotransferase level ≤ upper normal limit after 12 weeks of therapy

Outcome measures

Measure	Algeron n=70 Participants 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 n=70 Participants 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	PegIntron - HCV-1 Patients with HCV genotype 1, received 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	PegIntron - HCV-2/3 Patients with HCV genotype 2 or 3, received 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
Biochemical Response	68.6 percentage of patients	82.9 percentage of patients	—	—

Adverse Events

Algeron

Serious events: 0 serious events

Other events: 70 other events

Deaths: 0 deaths

PegIntron

Serious events: 2 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Measure	Algeron n=70 participants at risk 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 n=71 participants at risk 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 The safety analysis included 71 patients received at least 1 dose of PegIntron (taking into account one patient withdrawn at early stages of the study due to a protocol violation \[previous treatment of hepatitis C with interferon alfa\], who was withdrawn from the mITT-analysis)
Blood and lymphatic system disorders CTCAE 4.03 Grade 4 anemia	0.00% 0/70 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	1.4% 1/71 • Number of events 1 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Respiratory, thoracic and mediastinal disorders cavitary pulmonary tuberculosis	0.00% 0/70 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	1.4% 1/71 • Number of events 1 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.

Other adverse events

Measure	Algeron n=70 participants at risk 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 n=71 participants at risk 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 The safety analysis included 71 patients received at least 1 dose of PegIntron (taking into account one patient withdrawn at early stages of the study due to a protocol violation \[previous treatment of hepatitis C with interferon alfa\], who was withdrawn from the mITT-analysis)
General disorders Flu-like syndrome	54.3% 38/70 • Number of events 46 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	57.7% 41/71 • Number of events 87 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
General disorders Asthenia (weakness, fatigue)	24.3% 17/70 • Number of events 25 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	22.5% 16/71 • Number of events 23 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Nervous system disorders Headache	17.1% 12/70 • Number of events 38 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	18.3% 13/71 • Number of events 25 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Psychiatric disorders Irritability, emotional lability	5.7% 4/70 • Number of events 4 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	5.6% 4/71 • Number of events 4 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Nervous system disorders Sleep disorders	5.7% 4/70 • Number of events 6 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	4.2% 3/71 • Number of events 3 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Gastrointestinal disorders Nausea	10.0% 7/70 • Number of events 21 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	2.8% 2/71 • Number of events 8 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Gastrointestinal disorders Stomach pain	10.0% 7/70 • Number of events 9 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	7.0% 5/71 • Number of events 5 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Gastrointestinal disorders Decreased appetite	5.7% 4/70 • Number of events 4 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	1.4% 1/71 • Number of events 1 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Gastrointestinal disorders Diarrhea	4.3% 3/70 • Number of events 3 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	5.6% 4/71 • Number of events 7 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 7/70 • Number of events 11 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	8.5% 6/71 • Number of events 18 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Musculoskeletal and connective tissue disorders Arthralgia	5.7% 4/70 • Number of events 7 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	8.5% 6/71 • Number of events 10 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Musculoskeletal and connective tissue disorders Back pain	5.7% 4/70 • Number of events 16 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	4.2% 3/71 • Number of events 6 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Skin and subcutaneous tissue disorders Skin itch	5.7% 4/70 • Number of events 7 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	2.8% 2/71 • Number of events 2 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Skin and subcutaneous tissue disorders Skin redness	7.1% 5/70 • Number of events 5 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	1.4% 1/71 • Number of events 1 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Skin and subcutaneous tissue disorders Skin dryness and exfoliation	5.7% 4/70 • Number of events 4 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	2.8% 2/71 • Number of events 2 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Blood and lymphatic system disorders Leucopenia	85.7% 60/70 • Number of events 67 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	83.1% 59/71 • Number of events 69 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Blood and lymphatic system disorders Neutropenia	75.7% 53/70 • Number of events 67 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	71.8% 51/71 • Number of events 66 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Blood and lymphatic system disorders Lymphopenia	61.4% 43/70 • Number of events 52 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	77.5% 55/71 • Number of events 62 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Blood and lymphatic system disorders Decreased level of CD4+ lymphocytes	11.4% 8/70 • Number of events 8 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	8.5% 6/71 • Number of events 6 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Blood and lymphatic system disorders Thrombocytopenia	55.7% 39/70 • Number of events 39 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	50.7% 36/71 • Number of events 37 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Blood and lymphatic system disorders Need in filgrastim	11.4% 8/70 • Number of events 8 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	2.8% 2/71 • Number of events 2 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Blood and lymphatic system disorders Anemia	70.0% 49/70 • Number of events 50 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	80.3% 57/71 • Number of events 59 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Blood and lymphatic system disorders Need in Rebetol dose correction due to anemia	17.1% 12/70 • Number of events 12 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	15.5% 11/71 • Number of events 11 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Hepatobiliary disorders Hyperbilirubinaemia	31.4% 22/70 • Number of events 27 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	36.6% 26/71 • Number of events 28 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Hepatobiliary disorders Direct bilirubin increased	44.3% 31/70 • Number of events 33 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	43.7% 31/71 • Number of events 34 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Hepatobiliary disorders Increased albumin	22.9% 16/70 • Number of events 17 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	35.2% 25/71 • Number of events 29 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Hepatobiliary disorders Increased alanine aminotranferase	35.7% 25/70 • Number of events 26 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	25.4% 18/71 • Number of events 18 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Hepatobiliary disorders Increased aspartate aminotranferase	40.0% 28/70 • Number of events 32 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	40.8% 29/71 • Number of events 31 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Hepatobiliary disorders Increased gamma glumamyltransferase	30.0% 21/70 • Number of events 21 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	43.7% 31/71 • Number of events 36 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Hepatobiliary disorders Increased alkaline phosphotase	10.0% 7/70 • Number of events 7 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	8.5% 6/71 • Number of events 6 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Endocrine disorders Hyperglycemia	8.6% 6/70 • Number of events 6 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	11.3% 8/71 • Number of events 8 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Endocrine disorders Hypoglycemia	14.3% 10/70 • Number of events 12 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	19.7% 14/71 • Number of events 15 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Metabolism and nutrition disorders Increased triglycerides	48.6% 34/70 • Number of events 38 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	52.1% 37/71 • Number of events 42 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Metabolism and nutrition disorders Increased cholesterol	15.7% 11/70 • Number of events 12 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	23.9% 17/71 • Number of events 17 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Endocrine disorders Increased thyroid stimulating hormone	5.7% 4/70 • Number of events 4 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	2.8% 2/71 • Number of events 2 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Renal and urinary disorders Increased creatinine	15.7% 11/70 • Number of events 11 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	8.5% 6/71 • Number of events 6 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.
Skin and subcutaneous tissue disorders Hyperemia	2.9% 2/70 • Number of events 2 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.	5.6% 4/71 • Number of events 4 • 12 weeks The number of patients for the efficacy analysis was 140 patients. 141 patients were included in the safety analysis, including 1 patient in PegIntron group withdrawn at early stages due to a violation of inclusion/non-inclusion criteria \[previous AVT cycle\], who was not considered to be enrolled in the study due to serious protocol violation.

Additional Information

Yulia Linkova Medical Director

Biocad

Phone: +7 (495) 992 66 28

Email: linkova@biocad.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place