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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Sponsor:
Collaborator:
Hospital de Clinicas de Porto Alegre
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier:
NCT01623336
First received: June 13, 2012
Last updated: June 15, 2012
Last verified: November 2011

June 13, 2012
June 15, 2012
January 2012
August 2016   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01623336 on ClinicalTrials.gov Archive Site
  • 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). ] [ Designated as safety issue: Yes ]
    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.
  • 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) ] [ Designated as safety issue: No ]
    Viral load will be measured by quantitative PCR at the end of treatment.
Same as current
Not Provided
Not Provided
 
BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys® (Peginterferon 2a 40kDa) for Treatment of Chronic Hepatitis C
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.

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 .

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • 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.
    Other Name: BIP 48 (Peginterferon alfa 2b 48kDA)
  • 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 Name: 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.
    Other Name: BIP 48 (Peginterferon alfa 2b 48kDA)
  • 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.
    Interventions:
    • Drug: BIP 48 (Peginterferon alfa 2b 48kDA)
    • Drug: Peginterferon alfa 2a 40kDA
  • Experimental: BIP 48 (Peginterferon alfa 2b 48kDA)
    Patients will receive BIP 48, 180 micrograms a week, SC, for the same period as Pegasys ®.
    Intervention: Drug: BIP 48 (Peginterferon alfa 2b 48kDA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
740
December 2016
August 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Valeria Lucia de S. Gil, ASCLIN 552138827199 valeria.lucia@bio.fiocruz.br
Contact: Maria de Lourdes de S. Maia, ASCLIN 552138829479 lourdes.maia@bio.fiocruz.br
Brazil
 
NCT01623336
11/0468
Yes
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Hospital de Clinicas de Porto Alegre
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
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
November 2011

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