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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Biocad.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01889433
First Posted: June 28, 2013
Last Update Posted: November 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biocad
June 26, 2013
June 28, 2013
November 13, 2015
November 2013
November 2016   (Final data collection date for primary outcome measure)
EVR [ Time Frame: 12 weeks ]
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
Same as current
Complete list of historical versions of study NCT01889433 on ClinicalTrials.gov Archive Site
  • RVR [ Time Frame: 4 weeks ]
    Proportion of randomized patients achieving rapid virologic response (RVR) - negative PCR result for HCV RNA (< 15 IU/ml) after 4 weeks of treatment.
  • SVR (24) [ Time Frame: 24 weeks after last dose of study treatment ]
    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
  • EOT [ Time Frame: 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 ]
    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).
  • Biochemical Response [ Time Frame: 12, 24, 48 weeks of treatment, and 24 weeks after last dose of study treatment ]
    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.
  • Histological Response [ Time Frame: 12 weeks of treatment and 24 weeks after last dose of study treatment ]
    Proportion of patients who have histological response, defined by a 1 level decrease in total METAVIR score measured on Fibroscan
  • RVR [ Time Frame: 4 weeks ]
    Proportion of randomized patients achieving rapid virologic response (RVR) - negative PCR result for HCV RNA (< 15 IU/ml) after 4 weeks of treatment.
  • SVR (24) [ Time Frame: 24 weeks after last dose of study treatment ]
    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
  • EOT [ Time Frame: 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 ]
    Proportion of patients who have 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).
  • Biochemical Response [ Time Frame: 12, 24, 48, and 24 weeks after last dose of study treatment ]
    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.
  • Histological Response [ Time Frame: 12 weeks of treatment and 24 weeks after last dose of study treatment ]
    Proportion of patients who have histological response, defined by a 1 level decrease in total METAVIR score measured on Fibroscan
Immunogenicity [ Time Frame: 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 ]
Proportion of randomized patients with neutralizing antibodies to IFN alfa
Same as current
 
An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C
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
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hepatitis
  • Hepatitis C
  • Drug: Algeron
    1.5 µg/kg of body weight subcutaneously, once a week
    Other Name: Cepeginterferon alfa-2b
  • Drug: Pegasys
    180 µg subcutaneously, once a week
    Other Name: Peginterferon alfa-2a
  • Experimental: 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).
    Intervention: Drug: Algeron
  • Active Comparator: Pegasys
    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)
    Intervention: Drug: Pegasys
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
500
November 2016
November 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belarus,   India,   Russian Federation,   Thailand
Brazil
 
NCT01889433
BCD-016-3
No
Not Provided
Not Provided
Biocad
Biocad
Not Provided
Principal Investigator: 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: 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
Biocad
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP