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

NCT02103439 | Completed Phase 3 Results

• 1 other identifier: BCD-016-4
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

Hepatitis; Hepatitis C; Hepatitis C/ Human Immunodeficiency Virus Coinfection

Keywords

Hepatitis C; Cepeginterferon alfa; Peginterferon; Treatment

Outcome Measures

Primary Outcomes (2)

• Early Virological Response

  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

  12 weeks

• Early Virological Response in Patients With Different Hepatitis C Virus Genotypes

  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

  12 weeks

Secondary Outcomes (4)

• Rapid Virological Response

  4 weeks

• Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes

  4 weeks

• Viral Breakthrough

  screening data and at 4 or 12 weeks of treatment.

• Biochemical Response

  12 weeks

Study Arms (2)

Algeron

EXPERIMENTAL

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)

Drug: Algeron

PegIntron

ACTIVE COMPARATOR

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).

Drug: PegIntron

Interventions

Algeron DRUG

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

Also known as: Cepeginterferon alfa-2b

Algeron

PegIntron DRUG

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

Also known as: peginterferon alfa-2b

PegIntron

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form.
• Chronic hepatitis C (genotypes 1а, 1b, 2, 3, 4) confirmed by positive result of hepatitis C virus ribonucleic acid during \> 6 months before screening visit or accompanied with increase in alanine aminotransferase (ALT) level \> 6 months before screening visit.
• Confirmed Human Immunodeficiency Virus-1 infection based on enzyme-linked immunosorbent assay and immune blotting results.
• Level of CD4+-lymphocytes is not less than 500 cells/mm3 for patients not requiring highly active antiretroviral therapy and which will not be assigned to antiretroviral therapy during the study period.
• For patients receiving sustained highly active antiretroviral therapy for not less than 12 weeks and planning to continue comply with this treatment regimen during the following 24 weeks, level of CD4+-lymphocytes ≥300 cells/mm3, Human Immunodeficiency Virus ribonucleic acid ≤50 copies/ml.
• Men and women aged 18 to 70 inclusively.
• Body mass index in the range of 18 - 30 kg/m2 inclusively .
• Preserved protein-synthetizing liver function (International Normalized Ratio \< 1.7, albumin \> 35 g/l).
• Absence of signs of hepatic encephalopathy and ascites according to clinical examination and ultrasound examination.
• Patients with preserved child-bearing potential and their partners agree to use barrier method of contraception during the whole period of therapy and during 7 months after the treatment completion.
• Documentary confirmed results of liver elastography (fibroscan) during last year before enrollment in the study or patient agreement to undergo this examination during screening.

You may not qualify if:

• Intolerance of alfa-interferons, ribavirin or any components of tested drug product based on medical history.
• Presence of hepatitis B, A, E markers.
• Presence of documentary confirmed clinically significant concurrent liver diseases (alcoholic liver cirrhosis, drug-induced liver cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, biliary cirrhosis etc.).
• Past history of Hepatitis C Virus treatment with interferon alfa or pegylated interferon alfa.
• For patients receiving sustained highly active antiretroviral therapy - presence of nevirapine, stavudine, zidovudine, didanosine in treatment regimen.
• Cholestic hepatitis (level of direct bilirubin, alkaline phosphatase, gamma glutamyltransferase, exceeding upper normal limit in \> 5 times).
• Decompensated liver cirrhosis confirmed with results of laboratory analyses (Child-Pugh class B, C) or ultrasound examination.
• Any documentary confirmed autoimmune diseases (such as Crohn's disease, ulcerative colitis, systemic lupus erythematosus, idiopathic thrombocytopenic purpura, scleroderma, autoimmune hemolytic anemia, severe psoriasis).
• Deviations of hematologic (hemoglobin less than lower normal limit; neutrophils \< 1.5 x 10\^9/l; thrombocytes \< 90 x 10\^9/ l) and biochemical (creatinine level \> 1.5 times higher upper normal limit, ALT is \> 10 times higher upper normal limit) parameters.
• Documentary confirmed diagnosis of hemoglobinopathy (for example, thalassemia, sickle-cell anemia).
• Severe depression, schizophrenia, any other mental disorders which according to the investigator are contraindications for antiviral treatment.
• Epilepsy and/or central nervous system disorder.
• Disorder of thyroid function (level of thyroid stimulating hormone out of the normal range).
• Documentary confirmed or suspected hepatocellular carcinoma based on the results of alfa-fetoprotein (AFP) assay ≥ upper normal limit.
• Antinuclear antibodies (ANA) titer measured at screening is not less than 1:640 or documentary confirmed signs of autoimmune hepatitis based on the results of biopsy.

Sponsors & Collaborators

• Biocad: lead

Study Sites (6)

State Public Healthcare Institution National Center for the Prevention and Control of AIDS and other infectious diseases of the Ministry of Health of the Republic of Tatarstan

Kazan', Tatarstan Republic, 420097, Russia

Location

State Institution of Nizhny Novgorod region "Regional Center for Prevention and Control of AIDS and other infectious diseases"

Nizhny Novgorod, 603005, Russia

Location

State Healthcare Institution Center for the Prevention and Control of AIDS and infectious diseases of the city, St.Petersburg CityHealth Department

Saint Petersburg, 190103, Russia

Location

State Budgetary Higher Vocational Education Institution V.I. Razumovsky Saratov State University of medicine

Saratov, 410012, Russia

Location

State Budgetary Higher Vocational Education Institution Pacific State Medical University, Ministry of Health of the Russian Federation

Vladivostok, 690002, Russia

Location

State Healthcare Institution "Volgograd Regional Center for the Prevention and Control of AIDS and infectious diseases"

Volgograd, 400040, Russia

Location

MeSH Terms

Conditions

Hepatitis; Hepatitis C

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections

Results Point of Contact

• Title: Yulia Linkova Medical Director
• Organization: Biocad

linkova@biocad.ru

+7 (495) 992 66 28

Study Officials

• Gregory Moshkovich, M.D.

  State Institution of Nizhny Novgorod region "Regional Center for Prevention and Control of AIDS and other infectious diseases"

  PRINCIPAL INVESTIGATOR

• Firaya Nagimova, PhD

  State Public Healthcare Institution National Center for the Prevention and Control of AIDS and other infectious diseases of the Ministry of Health of the Republic of Tatarstan

  PRINCIPAL INVESTIGATOR

• Oleg Kozyrev, PhD

  State Healthcare Institution "Volgograd Regional Center for the Prevention and Control of AIDS and infectious diseases"

  PRINCIPAL INVESTIGATOR

• Andrey Shuldyakov, M.D., PhD

  State Budgetary Higher Vocational Education Institution V.I. Razumovsky Saratov State University of medicine

  PRINCIPAL INVESTIGATOR

• Vadim Rassokhin, PhD

  State Healthcare Institution Center for the Prevention and Control of AIDS and infectious diseases of the city, St.Petersburg CityHealth Department

  PRINCIPAL INVESTIGATOR

• Lidia Sklar, M.D., PhD

  State Budgetary Higher Vocational Education Institution Pacific State Medical University, Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 3, 2014
• Study Start: June 6, 2013
• Primary Completion: August 26, 2015
• Study Completion: August 26, 2015
• Last Updated: August 9, 2018
• Results First Posted: July 21, 2015

Record last verified: 2018-07

Locations

RU (6)