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

NCT01623336 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 740

Last updated 2012-06-20

No results posted yet for this study

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.

Conditions

  • Chronic Hepatitis C

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.

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Paulo D. Picon, Invest · Hospital de Clínicas de Porto Alegre

  • Guilherme B. Sander, Coord · Hospital de Clínicas de Porto Alegre

  • Luiz E. Mazzoleni, Coord · Hospital de Clínicas de Porto Alegre

  • André C. Wortmann, Monitor · NUCLIMED

  • Karine M. Amaral, Coordenação · NUCLIMED

  • Marisa B. Costa, Sub Coord · NUCLIMED

  • Tobias C. Milbradt, Coord Log. · NUCLIMED

  • Indara C. Saccilotto, Coordenação · NUCLIMED

  • Amanda Quevedo, Sub Coord · NUCLIMED

  • Daiana V. Gomes, AssitSocial · NUCLIMED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623336 on ClinicalTrials.gov