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

Primary Purpose

Chronic Hepatitis C

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

BIP 48 (Peginterferon alfa 2b 48kDA)

Peginterferon alfa 2a 40kDA

BIP 48 (Peginterferon alfa 2b 48kDA)

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HEPATITIS, HEPATITIS C, PEGINTERFERON, BIOEQUIVALENCE, TREATMENT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
chronic renal failure;
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);
prior organ transplantation, except cornea;
alcohol consumption exceeding 20g/day for women and 40g/dia for men during the past six months;
use of illicit drugs in the previous six months;
use of immunosuppressive agents during the previous six months;
pregnancy or lactation;
male research subjects whose sexual partner is pregnant;
previous treatment with IFN or ribavirin in the last 6 months prior to inclusion;
subjects with hypersensibility to IFN alpha and / or any of its components;
subjects with hypersensibility to ribavirin and / or any of its ingredients;
participation in another clinical study in the last 12 months

Sites / Locations

Ufrgs/HcpaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pegasys ®

BIP 48 (Peginterferon alfa 2b 48kDA)

Arm Description

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.

Patients will receive BIP 48, 180 micrograms a week, SC, for the same period as Pegasys ®.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of adverse events

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

Viral load will be measured by quantitative PCR at the end of treatment.

Full Information

NCT ID

NCT01623336

First Posted

June 13, 2012

Last Updated

June 15, 2012

Sponsor

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

Collaborators

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT01623336

Brief Title

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

Acronym

BIP48II/III

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 Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

HEPATITIS, HEPATITIS C, PEGINTERFERON, BIOEQUIVALENCE, TREATMENT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

740 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pegasys ®

Arm Type

Active Comparator

Arm Description

Arm Title

BIP 48 (Peginterferon alfa 2b 48kDA)

Arm Type

Experimental

Arm Description

Patients will receive BIP 48, 180 micrograms a week, SC, for the same period as Pegasys ®.

Intervention Type

Drug

Intervention Name(s)

BIP 48 (Peginterferon alfa 2b 48kDA)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Peginterferon alfa 2a 40kDA

Other Intervention Name(s)

Pegasys ®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

BIP 48 (Peginterferon alfa 2b 48kDA)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

Frequency of adverse events

Description

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).

Title

Virologic response at the end of treatment

Description

Viral load will be measured by quantitative PCR 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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; chronic renal failure; 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); prior organ transplantation, except cornea; alcohol consumption exceeding 20g/day for women and 40g/dia for men during the past six months; use of illicit drugs in the previous six months; use of immunosuppressive agents during the previous six months; pregnancy or lactation; male research subjects whose sexual partner is pregnant; previous treatment with IFN or ribavirin in the last 6 months prior to inclusion; subjects with hypersensibility to IFN alpha and / or any of its components; subjects with hypersensibility to ribavirin and / or any of its ingredients; participation in another clinical study in the last 12 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Valeria Lucia de S. Gil, ASCLIN

Phone

552138827199

valeria.lucia@bio.fiocruz.br

First Name & Middle Initial & Last Name or Official Title & Degree

Maria de Lourdes de S. Maia, ASCLIN

Phone

552138829479

lourdes.maia@bio.fiocruz.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paulo D. Picon, Invest

Organizational Affiliation

Hospital de Clínicas de Porto Alegre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Guilherme B. Sander, Coord

Organizational Affiliation

Hospital de Clínicas de Porto Alegre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Luiz E. Mazzoleni, Coord

Organizational Affiliation

Hospital de Clínicas de Porto Alegre

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

André C. Wortmann, Monitor

Organizational Affiliation

NUCLIMED

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Karine M. Amaral, Coordenação

Organizational Affiliation

NUCLIMED

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Marisa B. Costa, Sub Coord

Organizational Affiliation

NUCLIMED

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tobias C. Milbradt, Coord Log.

Organizational Affiliation

NUCLIMED

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Indara C. Saccilotto, Coordenação

Organizational Affiliation

NUCLIMED

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Amanda Quevedo, Sub Coord

Organizational Affiliation

NUCLIMED

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Daiana V. Gomes, AssitSocial

Organizational Affiliation

NUCLIMED

Official's Role

Study Chair

Facility Information:

Facility Name

Ufrgs/Hcpa

City

Porto Alegre

State/Province

Rio Grande do Sul

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria de Lourdes S. Maia, ASCLIN

Phone

552138829479

mlourdes@bio.fiocruz.br

First Name & Middle Initial & Last Name & Degree

Vivian Rotman, ASCLIN

Phone

552138829474

vivian.rotman@bio.fiocruz.br

First Name & Middle Initial & Last Name & Degree

Paulo D. Picon, PI

First Name & Middle Initial & Last Name & Degree

Guilherme B. Sander, Coord

First Name & Middle Initial & Last Name & Degree

Luiz E. Mazzoleni, Coord

12. IPD Sharing Statement

Citations:

PubMed Identifier

34307188

Citation

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.

Results Reference

derived

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

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