BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys® (Peginterferon 2a 40kDa) for Treatment of Chronic Hepatitis C (BIP48II/III)

June 15, 2012 updated by: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Safety and Efficacy of BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys® (Peginterferon 2a 40kDa) for Treatment of Chronic Hepatitis C: Randomized, Multicentric Study With Blinded Analysis

The purpose of the study is to demonstrate the noninferiority of BIP48 (48 kDa peginterferon alfa-2b) compared to Pegasys ® (40 kDa peginterferon alfa-2a) associated with ribavirin, in naive patients with chronic hepatitis C.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will be an open, multicenter, randomized, controlled phase II - III trial. Patients (n = 740) will be randomized (1:1) to receive BIP48 (peginterferon alfa-2b 48kDa) or Pegasys ® (peginterferon alfa-2a 40kDa) 180 micrograms ,subcutaneously,once a week,associated with ribavirin at a dose 1000-1250 mg, orally, daily. For genotype 1 treatment time will be 48 to 72 weeks and for genotypes 2 and 3, 24 to 48 weeks. The study's population will be naive patients, of both sex, between 18 and 70 years old, with chronic hepatitis C (HCV), genotypes 1, 2 or 3, from 18 to 25 Brazilian research centers. Diagnostic criteria will be as followed: positive anti-HCV and qualitative PCR, liver biopsy showing any degree of fibrosis and at least mild inflammatory activity, performed in the last 24 months. The interruption Criteria will be: no partial virological response at 12 weeks and positive quantitative PCR at week 24.The primary outcome will be the rate of sustained virologic response and the secondary endpoints will be the quality of life during treatment, frequency of adverse events and cost-effectiveness. As a substudy, will be performed a comparative assessment in 24 patients, evaluating viral kinetics, pharmacokinetics and pharmacodynamics of repeated doses of both alfapeginterferons .

Study Type

Interventional

Enrollment (Anticipated)

740

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Recruiting
        • Ufrgs/Hcpa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paulo D. Picon, PI
        • Sub-Investigator:
          • Guilherme B. Sander, Coord
        • Sub-Investigator:
          • Luiz E. Mazzoleni, Coord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. anti-HCV positive;
  2. viral load of HCV positive;
  3. viral genotypes 1, 2 or 3;
  4. the absence of previous treatment for chronic hepatitis C;
  5. liver biopsy performed in the last 36 months classified by Metavir score as at least A1, with any degree of fibrosis ;
  6. age from 18 to 70 years old;
  7. hemoglobin greater than 11 g / dl;
  8. platelet count higher than 75.000/mm3;
  9. neutrophils higher than 1.500/mm3;
  10. use of, at least two contraceptive methods during treatment and up to 36 weeks after the last dose of study medication (for male or female subjects in fertile age );
  11. concordance and signing of the informed consent.

Exclusion Criteria:

  1. decompensated cirrhosis (Child-Pugh score> 6);
  2. history of bleeding gastroesophageal varices;
  3. hemoglobinopathies;
  4. hepatocellular carcinoma;
  5. co-infection with HIV or HBV;
  6. other coexisting chronic liver disease, as autoimmune hepatitis, Wilson disease, hemochromatosis, chronic obstructive cholestatic disease or autoimmune disease, alcoholic liver disease;
  7. malignancies except basal cell carcinoma in situ or cervix carcinoma;
  8. systemic autoimmune diseases, except compensated autoimmune thyroid diseases ;
  9. uncontrolled seizures;
  10. primary immunodeficiencies;
  11. myelosuppression;
  12. coagulation disorders;
  13. thrombophilias;
  14. thrombopathy ;
  15. decompensated heart failure;
  16. chronic renal failure;
  17. diagnosis of other comorbidity that would compromise the subject's participation in the research study as judged by the investigator (eg, neuropsychiatric diseases, systemic infection or antibiotic use within 4 weeks, decompensated diabetes mellitus, ischemic heart disease, heart failure, respiratory or renal or uncontrolled hypertension);
  18. prior organ transplantation, except cornea;
  19. alcohol consumption exceeding 20g/day for women and 40g/dia for men during the past six months;
  20. use of illicit drugs in the previous six months;
  21. use of immunosuppressive agents during the previous six months;
  22. pregnancy or lactation;
  23. male research subjects whose sexual partner is pregnant;
  24. previous treatment with IFN or ribavirin in the last 6 months prior to inclusion;
  25. subjects with hypersensibility to IFN alpha and / or any of its components;
  26. subjects with hypersensibility to ribavirin and / or any of its ingredients;
  27. participation in another clinical study in the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pegasys ®
Patients will receive Pegasys ® (peginterferon alfa-2a 40kDa) at a dose of 180 micrograms, subcutaneously, once a week, associated with ribavirin at a dose 1000-1250 mg,daily. For genotype 1 treatment time is 48 to 72 weeks and for genotypes 2 and 3, 24 weeks.
Drug: BIP 48 (Peginterferon alfa 2b 48kDA)
BIP 48 (Peginterferon alfa 2b 48kDA)will be administered in a dose of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3, and for 48 to 72 weeks to genotype 1.
Drug: Peginterferon alfa 2a 40kDA
Patients will receive Pegasys ® in a dosage of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3 and for 48 to 72 weeks to genotype 1.
Other Names:
  • Pegasys ®
Drug: BIP 48 (Peginterferon alfa 2b 48kDA)
Patients will receive BIP 48 in a dosage of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3 and for 48 to 72 weeks to genotype 1.
Experimental: BIP 48 (Peginterferon alfa 2b 48kDA)
Patients will receive BIP 48, 180 micrograms a week, SC, for the same period as Pegasys ®.
Drug: BIP 48 (Peginterferon alfa 2b 48kDA)
BIP 48 (Peginterferon alfa 2b 48kDA)will be administered in a dose of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3, and for 48 to 72 weeks to genotype 1.
Drug: BIP 48 (Peginterferon alfa 2b 48kDA)
Patients will receive BIP 48 in a dosage of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3 and for 48 to 72 weeks to genotype 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of sustained virologic response - SVR - measured by PCR at 24 weeks after treatment.
Time Frame: HCV PCR will be measured at 24 weeks after the end of therapy (week 48 for genotypes 2 and 3 and week 72 for genotype 1)
HCV PCR will be measured at 24 weeks after the end of therapy (week 48 for genotypes 2 and 3 and week 72 for genotype 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of adverse events
Time Frame: Clinical exam, blood tests and immunogenicity evaluation will be done twice monthly, in the first month, and then monthly until the end of treatment( week 24 for genotypes 2 and 3 and week 48 for genotype 1).
Blood tests included: ALT, AST, Creatinine and complete blood count. Anti-interferon immunoglobulin and thyroid-stimulating hormone (TSH) will be measured in the weeks 12, 24, 36, 48, 60 and 72 of the study.
Clinical exam, blood tests and immunogenicity evaluation will be done twice monthly, in the first month, and then monthly until the end of treatment( week 24 for genotypes 2 and 3 and week 48 for genotype 1).
Virologic response at the end of treatment
Time Frame: Viral load will be measured at the end of treatment (week 24 for genotypes 2 and 3 and week 48 for genotype 1)
Viral load will be measured by quantitative PCR at the end of treatment.
Viral load will be measured at the end of treatment (week 24 for genotypes 2 and 3 and week 48 for genotype 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Paulo D. Picon, Invest, Hospital de Clínicas de Porto Alegre
  • Study Director: Guilherme B. Sander, Coord, Hospital de Clínicas de Porto Alegre
  • Study Director: Luiz E. Mazzoleni, Coord, Hospital de Clínicas de Porto Alegre
  • Study Chair: André C. Wortmann, Monitor, NUCLIMED
  • Study Chair: Karine M. Amaral, Coordenação, NUCLIMED
  • Study Chair: Marisa B. Costa, Sub Coord, NUCLIMED
  • Study Chair: Tobias C. Milbradt, Coord Log., NUCLIMED
  • Study Chair: Indara C. Saccilotto, Coordenação, NUCLIMED
  • Study Chair: Amanda Quevedo, Sub Coord, NUCLIMED
  • Study Chair: Daiana V. Gomes, AssitSocial, NUCLIMED

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 15, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/0468

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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