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Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT01740089
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : August 18, 2015
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Biocad

Brief Summary:
The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.

Condition or disease Intervention/treatment Phase
Hepatitis Hepatitis C Drug: Algeron Drug: PegIntron Drug: Ribavirin Phase 2 Phase 3

Detailed Description:
After 12 weeks of treatment, an assessment of treatment efficacy was performed, i.e. rates of rapid (after 4 weeks) and early (after 12 weeks) virologic responses according to serum HCV RNA level PCR data. In patients without virologic response after 12 weeks, AVT was discontinued, and they were withdrawn from the study. Patients with EVR were enrolled in a follow-up period. During the follow-up period, patients of the first and the second group will receive Algeron in the selected therapeutic dose in combination with ribavirin, patients of the third group - PegIntron in combination with ribavirin during 12 or 36 weeks (depending on a genotype of the virus), afterwards they will be followed up without therapy for 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Open-label Randomized Prospective Clinical Study of Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b) in Comparison With PegIntron (Peginterferon Alfa-2b) in the Combined Treatment of Chronic Hepatitis C
Study Start Date : November 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Algeron 1.5 μg/kg
Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Drug: Algeron
1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
Other Name: cepeginterferon alfa-2b

Drug: Ribavirin
800-1400 mg/day orally

Experimental: Algeron 2.0 μg/kg
Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Drug: Algeron
1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
Other Name: cepeginterferon alfa-2b

Drug: Ribavirin
800-1400 mg/day orally

Active Comparator: PegIntron
PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).
Drug: PegIntron
1.5 μg/kg/week subcutaneously in combination with ribavirin
Other Name: Peginterferon alfa-2b

Drug: Ribavirin
800-1400 mg/day orally




Primary Outcome Measures :
  1. Number 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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Number of Randomized Patients Achieving Rapid Virologic Response (RVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment. [ Time Frame: 4 weeks ]
  2. Number 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. [ Time Frame: 24 weeks after last dose of study treatment ]
  3. Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment. [ 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. ]

Other Outcome Measures:
  1. Immunogenicity [ Time Frame: Weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment ]
    Number of randomized patients with neutralizing antibodies to IFN alfa on weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent to participate in the study.
  2. Hepatitis С virus infection (genotypes 1а, 1b, 2, 3, 4) confirmed by a positive quantitative PCR (HCV RNA > 50 IU/ml).
  3. Males and females aged from 18 to 70 years inclusive.
  4. Body mass index of 18 - 30 kg/m inclusive.
  5. Increased ALT level (> 40, < 400 IU/L), documented at least twice within the last 6 months.
  6. Preserved protein synthetic liver function (i.e. INR < 1.7, albumin > 35 g/l).
  7. No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination.
  8. Fertile patients and their partners agree to use barrier contraception throughout the study and 7 months after its completion.

Exclusion Criteria:

  1. Intolerance of IFN alpha formulations, ribavirin or any components of these drugs according to the past medical history.
  2. Infection by hepatitis B virus or HIV.
  3. Past history of HCV treatment with IFN alfa or pegylated IFN alfa formulations.
  4. Administration of interferons and/or interferon inducing drugs for any indication within 1 month prior to the enrollment into the study.
  5. Cholestatic hepatitis (conjugated bilirubin, alkaline phosphatase, ALT levels of more than 5 ULN).
  6. Decompensated liver cirrhosis confirmed by laboratory findings (Child-Pugh class B, С) or ultrasound examination.
  7. Any documented autoimmune diseases.
  8. Hematologic (hemoglobin < 130 g/L for males and < 120 g/L for females; neutrophils < 1.5 х109/L; platelets < 90 х109/L) or biochemical abnormalities (creatinine level of more than 1.5 ULN, creatinine clearance less than 50 mL/min).
  9. Documented diagnosis of hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
  10. Heavy depression, any other mental disorders, which in the Investigator's opinion can be contraindications for antiviral treatment.
  11. Epilepsy and/or other functional disorders of the central nervous system.
  12. Abnormal thyroid function (TTH level beyond the normal values).
  13. Malignant neoplasms.
  14. Pregnancy, lactation period.
  15. Severe comorbidities (for example, severe hypertension, severe coronary heart disease, decompensated diabetes mellitus), which in the Investigator's opinion can be contraindications for antiviral treatment.
  16. Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption.
  17. Current alcohol or drug abuse, which in the Investigator's opinion can be contraindications for antiviral treatment or restrict treatment compliance.
  18. Simultaneous participation in other clinical trials or prior participation in this or another clinical trial within less than 30 days after its completion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740089


Locations
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Russian Federation
Moscow State University of Medicine and Dentistry
Moscow, Russian Federation, 127473
Sponsors and Collaborators
Biocad
Investigators
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Principal Investigator: Olga Znoyko, professor Moscow State University of Medicine and Dentistry
Principal Investigator: Marina Maevskaya, professor The First Moscow State Sechenov Medical University
Principal Investigator: Svetlana Kizhlo Health Department "Center for Prevention and Control of AIDS and Infectious Diseases"
Principal Investigator: Natalia Petrochenkova Smolensk State Medical Academy
Principal Investigator: Semen Maximov Moscow State University of Medicine and Dentistry
Principal Investigator: Firaja Nagimova Kazan State Medical University
Principal Investigator: Vladimur Yakovlev 7. St. Petersburg State Institution of Health "Clinical Infectious Diseases Hospital named SP Botkin"

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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT01740089     History of Changes
Other Study ID Numbers: PEG-IFNа-2
First Posted: December 4, 2012    Key Record Dates
Results First Posted: August 18, 2015
Last Update Posted: August 18, 2015
Last Verified: July 2015
Keywords provided by Biocad:
Hepatitis C
Cepeginterferon alfa
Peginterferon
Treatment
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs