BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys

BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys®
(Peginterferon 2a 40kDa) for Treatment of Chronic Hepatitis C
Status: Recruiting
Study Phase: Phase 2/Phase 3
Start Date: January 2012 | Completion Date: December 2016
Condition(s): Chronic Hepatitis C
Full Title of Study
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
Overview
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.
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 Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study,
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose:
Treatment
Investigator Details
Lead Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) /
Oswaldo Cruz Foundation (Fiocruz)
Collaborator: 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
Trial Location Details
Facility: Ufrgs/Hcpa Porto Alegre, Brazil
Principal Investigator: Paulo D. Picon, PI
Sub-Investigator: Guilherme B. Sander, Coord
Sub-Investigator: Luiz E. Mazzoleni, Coord
Interventions
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.
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.
Information Source
ID Number: 11/0468
NCT Identifier: NCT01623336
Health Authority: Brazil: The Immunobiological Technology Institute (BIO-Manguinhos)/Oswaldo Cruz
Foundation
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01623336
ClinicalTrials.gov processed this data on September 29, 2016
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