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The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.
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 PCR 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 / Pegasys and ribavirin for another 12 or 36 weeks (depending on the HCV genotype). Sustained virologic response will be assessed 24 weeks after last dose of study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Pegasys | Active Comparator | Pegasys in a dose of 180 µg subcutaneously, once a week, in combination with Rebetol, orally, at a daily dose of 800 mg for patients with genotype 2 or 3, and for genotypes 1 or 4 at a daily dose of 1000 mg (for body weight <75 kg) or 1200 mg (for body weight ≥75 kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algeron | Drug | 1.5 µg/kg of body weight subcutaneously, once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| EVR | Proportion of randomized patients achieving early virologic response (EVR) - negative PCR result for HCV RNA (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| RVR | Proportion of randomized patients achieving rapid virologic response (RVR) - negative PCR result for HCV RNA (< 15 IU/ml) after 4 weeks of treatment. | 4 weeks |
| SVR (24) | Proportion of randomized patients achieving sustained virologic response (SVR) - negative PCR result for HCV RNA (< 15 IU/ml) 24 weeks after last dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Proportion of randomized patients with neutralizing antibodies to IFN alfa | Week 0, 12, 24, and additionally for patients with HCV 1, 4 genotype - week 48 after first administration of Algeron / Pegasys and 24 weeks after last dose of study treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantin Zhdanov, Professor | Federal State Military Higher Vocational Education Institution S.M. Kirov Military Medical Academy | Principal Investigator |
| Olga Znoyko, Professor | State Budgetary Higher Vocational Education Institution A.I. Evdokimov Moscow State University of Medicine and Dentistry | Principal Investigator |
| Marina Maevskaya, Professor | State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University | Principal Investigator |
| Vjacheslav Morozov | LLC Medical Company "Hepatolog", Samara, Russia | Principal Investigator |
| Natalja Mironova, PhD | Municipal Healthcare Institution City Clinical Hospital No.2 named after V.I. Razumovsky, Healthcare Committee at the Administration of "Saratov City" Municipal District | Principal Investigator |
| Elena Nurmuhametova, PhD | State Public Healthcare Institution of the City of Moscow "Infectious Disease Clinical Hospital No. 1", Moscow City Health Department | Principal Investigator |
| Victor Pasechnikov, Professor | State Budgetary Higher Vocational Education Institution Stavropol State Medical Academy, Ministry of Health of the Russian Federation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gomel Regional Clinical Hospital | Homyel | 246029 | Belarus | |||
| Vitebsk Regional Clinical Hospital |
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| Pegasys | Drug | 180 µg subcutaneously, once a week |
|
|
| 24 weeks after last dose of study treatment |
| EOT | Proportion of randomized patients achieving end-of-treatment response (EOT) -undetectable HCV RNA (< 15 IU/ml) at the end of treatment (after 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4). | After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4 |
| Biochemical Response | Proportion of patients who have ALT level ≤ than upper normal level after 12 weeks of treatment, at the end of treatment (after 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment. | 12, 24, 48 weeks of treatment, and 24 weeks after last dose of study treatment |
| Histological Response | Proportion of patients who have histological response, defined by a 1 level decrease in total METAVIR score measured on Fibroscan | 12 weeks of treatment and 24 weeks after last dose of study treatment |
| Natalia Petrochenkova, PhD | State Budgetary Higher Vocational Education Institution Smolensk State Medical Academy | Principal Investigator |
| Tamara Sologub, Professor | Federal State Budgetary Institution Research Institute of Influenza, Ministry of Health of the Russian Federation, Saint-Petersburg | Principal Investigator |
| Vladimir Rafalskiy, Professor | Regional State Healthcare Institution "Smolensk Regional Clinical Hospital" | Principal Investigator |
| Evgeniy Chesnokov, Professor | State Medical and Preventive Institution of the Tyumen Region "Advisory and Diagnostic Center", Tyumen | Principal Investigator |
| Sandeep Gupta, Dr | M V Hospital & Research Center, 314/30 Mirza Mandi, Chowk 226003, Lucknow 226003, Uttar Pradesh, India | Principal Investigator |
| Tariq A Patil, Dr | Bhatia Hospital, Medical Research Society Tardeo Road, Grant Road (W), Maharashtra, India | Principal Investigator |
| Mandar Doiphode, Dr | Medipoint Hospitals Pvt. Ltd. Maharashtra, India | Principal Investigator |
| G S Malpani, Dr | Suyash Hospital Pvt. Ltd. Opposite M.G.M Medical College A.B. Road, Madhya Pradesh, India | Principal Investigator |
| Tawesak Tanwandee | Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Siriraj Hospital, Bangkoknoi, Bangkok, Thailand | Principal Investigator |
| Thongsawat Satawat | Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Sriphum, Muang, Chiang Mai, Thailand | Principal Investigator |
| Vitebsk |
| 210037 |
| Belarus |
| Suyash Hospital Pvt. Ltd. Opposite M.G.M Medical College A.B. Road | Indore | 452001 | India |
| M V Hospital & Research Center | Lucknow | 226003 | India |
| Bhatia Hospital, Medical Research Society Tardeo Road, Grant Road (W) | Mumbai | 400007 | India |
| Medipoint Hospitals Pvt. Ltd. | Pune | 411007 | India |
| State Budgetary Higher Vocational Education Institution A.I. Evdokimov Moscow State University of Medicine and Dentistry | Moscow | 127473 | Russia |
| State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University | Moscow | Russia |
| State Public Healthcare Institution of the City of Moscow "Infectious Disease Clinical Hospital No. 1" | Moscow | Russia |
| Federal State Budgetary Institution Research Institute of Influenza | Saint Petersburg | Russia |
| Federal State Military Higher Vocational Education Institution S.M. Kirov Military Medical Academy | Saint Petersburg | Russia |
| LLC Medical Company "Hepatolog" | Samara | Russia |
| Municipal Healthcare Institution City Clinical Hospital No.2 named after V.I. Razumovsky | Saratov | Russia |
| Smolensk Regional Clinical Hospital | Smolensk | Russia |
| State Budgetary Higher Vocational Education Institution Smolensk State Medical Academy | Smolensk | Russia |
| State Budgetary Higher Vocational Education Institution Stavropol State Medical Academy | Stavropol | Russia |
| State Medical and Preventive Institution of the Tyumen Region "Advisory and Diagnostic Center" | Tyumen | Russia |
| Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital | Bangkok | 10700 | Thailand |
| Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | 50200 | Thailand |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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