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

Information source: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: BIP 48 (Peginterferon alfa 2b 48kDA) (Drug); Peginterferon alfa 2a 40kDA (Drug); BIP 48 (Peginterferon alfa 2b 48kDA) (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

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

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

Overall contact:
Valeria Lucia de S. Gil, ASCLIN, Phone: 552138827199, Email: valeria.lucia@bio.fiocruz.br

Summary

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.

Clinical Details

Official title: 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

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

Primary outcome: The rate of sustained virologic response - SVR - measured by PCR at 24 weeks after treatment.

Secondary outcome:

Frequency of adverse events

Virologic response at the end of 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 .

Eligibility

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

Criteria:

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

Locations and Contacts

Valeria Lucia de S. Gil, ASCLIN, Phone: 552138827199, Email: valeria.lucia@bio.fiocruz.br

Ufrgs/Hcpa, Porto Alegre, Rio Grande do Sul, Brazil; Recruiting
Maria de Lourdes S. Maia, ASCLIN, Phone: 552138829479, Email: mlourdes@bio.fiocruz.br
Vivian Rotman, ASCLIN, Phone: 552138829474, Email: vivian.rotman@bio.fiocruz.br
Paulo D. Picon, PI, Principal Investigator
Guilherme B. Sander, Coord, Sub-Investigator
Luiz E. Mazzoleni, Coord, Sub-Investigator
Additional Information

Protocolo Clínico de Diretrizes Terapêiticas para Hepatite Viral C e Coinfecções

Starting date: January 2012
Last updated: June 15, 2012

Page last updated: August 23, 2015

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