DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C

Information source: Biocad
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis; Hepatitis C

Intervention: Algeron (Drug); Pegasys (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Biocad

Official(s) and/or principal investigator(s):
Konstantin Zhdanov, Professor, Principal Investigator, Affiliation: Federal State Military Higher Vocational Education Institution S.M. Kirov Military Medical Academy
Olga Znoyko, Professor, Principal Investigator, Affiliation: State Budgetary Higher Vocational Education Institution A.I. Evdokimov Moscow State University of Medicine and Dentistry
Marina Maevskaya, Professor, Principal Investigator, Affiliation: State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
Vjacheslav Morozov, Principal Investigator, Affiliation: LLC Medical Company "Hepatolog", Samara, Russia
Natalja Mironova, PhD, Principal Investigator, Affiliation: Municipal Healthcare Institution City Clinical Hospital No.2 named after V.I. Razumovsky, Healthcare Committee at the Administration of "Saratov City" Municipal District
Elena Nurmuhametova, PhD, Principal Investigator, Affiliation: State Public Healthcare Institution of the City of Moscow "Infectious Disease Clinical Hospital No. 1", Moscow City Health Department
Victor Pasechnikov, Professor, Principal Investigator, Affiliation: State Budgetary Higher Vocational Education Institution Stavropol State Medical Academy, Ministry of Health of the Russian Federation
Natalia Petrochenkova, PhD, Principal Investigator, Affiliation: State Budgetary Higher Vocational Education Institution Smolensk State Medical Academy
Tamara Sologub, Professor, Principal Investigator, Affiliation: Federal State Budgetary Institution Research Institute of Influenza, Ministry of Health of the Russian Federation, Saint-Petersburg
Vladimir Rafalskiy, Professor, Principal Investigator, Affiliation: Regional State Healthcare Institution "Smolensk Regional Clinical Hospital"
Evgeniy Chesnokov, Professor, Principal Investigator, Affiliation: State Medical and Preventive Institution of the Tyumen Region "Advisory and Diagnostic Center", Tyumen
Sandeep Gupta, Dr, Principal Investigator, Affiliation: M V Hospital & Research Center, 314/30 Mirza Mandi, Chowk 226003, Lucknow 226003, Uttar Pradesh, India
Tariq A Patil, Dr, Principal Investigator, Affiliation: Bhatia Hospital, Medical Research Society Tardeo Road, Grant Road (W), Maharashtra, India
Mandar Doiphode, Dr, Principal Investigator, Affiliation: Medipoint Hospitals Pvt. Ltd. Maharashtra, India
G S Malpani, Dr, Principal Investigator, Affiliation: Suyash Hospital Pvt. Ltd. Opposite M.G.M Medical College A.B. Road, Madhya Pradesh, India
Tawesak Tanwandee, Principal Investigator, Affiliation: Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Siriraj Hospital, Bangkoknoi, Bangkok, Thailand
Thongsawat Satawat, Principal Investigator, Affiliation: Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Sriphum, Muang, Chiang Mai, Thailand

Overall contact:
Andrey Biryulin, MD, Phone: (495) 992 66 28, Ext: 925

Summary

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.

Clinical Details

Official title: An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and Ribavirin With Pegasys (Peginterferon Alfa-2a) and Ribavirin for Treatment of Patients With Chronic Hepatitis C

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: EVR

Secondary outcome:

RVR

SVR (24)

EOT

Biochemical Response

Histological Response

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Signed informed consent to participate in the study. 2. Chronic HCV infection (genotypes 1а, 1b, 2, 3, 4) with detectable HCV RNA >6 month before the screening visit or abnormal ALT levels for >6 month before the screening visit. 3. Male and female patients, 18 to 70 years of age, inclusive.

4. Body mass index of 18 - 30 kg/m2.

5. Preserved protein synthetic liver function (INR < 1. 7, albumin > 35 g/l). 6. No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination. 7. Fertile patients and their partners agree to use barrier contraception throughout the study treatment and 7 months after it. 8. Patient must have documentation of fibroscan within 1 year before the screening visit or agree to have a fibroscan within the screening period. Exclusion Criteria: 1. Intolerance to IFN alfa, ribavirin or any components of this preparations confirmed by past medical history. 2. Infection by hepatitis B, A, E virus or HIV (co-infection). 3. Any other documented significant liver disease (drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, biliary cirrohosis, etc.). 4. Past history of HCV treatment with IFN alfa or pegylated IFN alfa. 5. Administration of injectable and non-injectable interferons and/or some interferon inducers for any indication (other than HCV) for one month before enrollment into the study. 6. Cholestatic hepatitis (level of conjugated bilirubin, alkaline phosphatase, G-GTP exceeding the upper normal level by more than 5 times). 7. Decompensated liver cirrhosis confirmed by laboratory findings (class B, С according to Child-Pugh) or ultrasound examination. 8. Any documented autoimmune diseases (e. g., Crohn's disease, ulcerative colitis, systemic lupus erythematosus, idiopathic thrombocytopenic purpura, scleroderma, autoimmune haemolytic anemia, severe psoriasis). 9. Hemoglobin not lower than low normal level; neutrophils < 1. 5 х109/L; platelets < 90 х109/L; creatinin level exceeding the upper normal level by more than 1. 5 times, ALT level exceeding the upper normal level by more than 10 times. 10. Documented hemoglobinopathies (e. g., thalassemia major, sickle-cell anemia). 11. Severe depression, schizophrenia, other mental disorders, which from the investigator's point of view are a contraindication for anti-viral treatment. 12. Epilepsy and/or disorder of function of the central nervous system. 13. Abnormal thyroid function (TTH level beyond the normal values). 14. Diagnosed or suspected hepatocellular carcinoma as evidenced by screening alfa-fetoprotein (AFP) of ≥ upper normal level. 15. Antinuclear antibody (ANA) titer ≥1: 640 at screening and/or evidence of autoimmune hepatitis on liver biopsy. 16. Malignant neoplasms. 17. Pregnancy, lactation period. 18. Severe comorbidities (for example, severe hypertension, severe coronary heart disease, decompensated diabetes mellitus) that represent a contraindication for anti-viral treatment. 19. Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption. 20. Known drug or alcohol abuse or signs of drug/alcohol abuse in present, which from the investigator's point of view are a contraindication for anti-viral treatment or restrict adherence to the treatment regimen. 21. Simultaneous participation in other clinical studies less than 30 days before enrollment into this study or previous participation in this clinical study.

Locations and Contacts

Andrey Biryulin, MD, Phone: (495) 992 66 28, Ext: 925

Gomel Regional Clinical Hospital, Gomel 246029, Belarus; Recruiting

Vitebsk Regional Clinical Hospital, Vitebsk 210037, Belarus; Recruiting

Suyash Hospital Pvt. Ltd. Opposite M.G.M Medical College A.B. Road, Indore 452001, India; Not yet recruiting

M V Hospital & Research Center, Lucknow 226003, India; Not yet recruiting

Bhatia Hospital, Medical Research Society Tardeo Road, Grant Road (W), Mumbai 400007, India; Not yet recruiting

Medipoint Hospitals Pvt. Ltd., Pune 411007, India; Not yet recruiting

State Budgetary Higher Vocational Education Institution A.I. Evdokimov Moscow State University of Medicine and Dentistry, Moscow 127473, Russian Federation; Enrolling by invitation

State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation; Recruiting

State Public Healthcare Institution of the City of Moscow "Infectious Disease Clinical Hospital No. 1", Moscow, Russian Federation; Recruiting

LLC Medical Company "Hepatolog", Samara, Russian Federation; Recruiting

Municipal Healthcare Institution City Clinical Hospital No.2 named after V.I. Razumovsky, Saratov, Russian Federation; Recruiting

Smolensk Regional Clinical Hospital, Smolensk, Russian Federation; Recruiting

State Budgetary Higher Vocational Education Institution Smolensk State Medical Academy, Smolensk, Russian Federation; Recruiting

Federal State Budgetary Institution Research Institute of Influenza, St. Petersburg, Russian Federation; Recruiting

Federal State Military Higher Vocational Education Institution S.M. Kirov Military Medical Academy, St. Petersburg, Russian Federation; Recruiting

State Budgetary Higher Vocational Education Institution Stavropol State Medical Academy, Stavropol, Russian Federation; Recruiting

State Medical and Preventive Institution of the Tyumen Region "Advisory and Diagnostic Center", Tyumen, Russian Federation; Recruiting

Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Bangkok 10700, Thailand; Recruiting

Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai 50200, Thailand; Recruiting

Additional Information

Starting date: November 2013
Last updated: July 17, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017