BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys® (Peginterferon 2a 40kDa) for Treatment of Chronic Hepatitis C
BIP48II/III
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
1 other identifier
interventional
740
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 13, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 20, 2012
November 1, 2011
4.6 years
June 13, 2012
June 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of sustained virologic response - SVR - measured by PCR at 24 weeks after treatment.
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 Outcomes (2)
Frequency of adverse events
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
Viral load will be measured at the end of treatment (week 24 for genotypes 2 and 3 and week 48 for genotype 1)
Study Arms (2)
Pegasys ®
ACTIVE COMPARATORPatients 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.
BIP 48 (Peginterferon alfa 2b 48kDA)
EXPERIMENTALPatients will receive BIP 48, 180 micrograms a week, SC, for the same period as Pegasys ®.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- anti-HCV positive;
- viral load of HCV positive;
- viral genotypes 1, 2 or 3;
- the absence of previous treatment for chronic hepatitis C;
- liver biopsy performed in the last 36 months classified by Metavir score as at least A1, with any degree of fibrosis ;
- age from 18 to 70 years old;
- hemoglobin greater than 11 g / dl;
- platelet count higher than 75.000/mm3;
- neutrophils higher than 1.500/mm3;
- 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 );
- concordance and signing of the informed consent.
You may not qualify if:
- decompensated cirrhosis (Child-Pugh score\> 6);
- history of bleeding gastroesophageal varices;
- hemoglobinopathies;
- hepatocellular carcinoma;
- co-infection with HIV or HBV;
- other coexisting chronic liver disease, as autoimmune hepatitis, Wilson disease, hemochromatosis, chronic obstructive cholestatic disease or autoimmune disease, alcoholic liver disease;
- malignancies except basal cell carcinoma in situ or cervix carcinoma;
- systemic autoimmune diseases, except compensated autoimmune thyroid diseases ;
- uncontrolled seizures;
- primary immunodeficiencies;
- myelosuppression;
- coagulation disorders;
- thrombophilias;
- thrombopathy ;
- decompensated heart failure;
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ufrgs/Hcpa
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (1)
da Silva AMV, Alvarado-Arnez LE, Azamor T, Batista-Silva LR, Leal-Calvo T, Bezerra OCL, Ribeiro-Alves M, Kehdy FSG, Neves PCDC, Bayma C, da Silva J, de Souza AF, Muller M, de Andrade EF, Andrade ACM, Dos Santos EM, Xavier JR, Maia MLS, Meireles RP, Cuni HN, Sander GB, Picon PD, Matos DCS, Moraes MO. Interferon-lambda 3 and 4 Polymorphisms Increase Sustained Virological Responses and Regulate Innate Immunity in Antiviral Therapy With Pegylated Interferon-Alpha. Front Cell Infect Microbiol. 2021 Jul 7;11:656393. doi: 10.3389/fcimb.2021.656393. eCollection 2021.
PMID: 34307188DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2012
First Posted
June 20, 2012
Study Start
January 1, 2012
Primary Completion
August 1, 2016
Study Completion
December 1, 2016
Last Updated
June 20, 2012
Record last verified: 2011-11