Chronic Hepatitis CPhase 2/3BIP48II/IIINCT01623336
BIP48 (Peginterferon Alfa 2b 48kDa) Compared With Pegasys® (Peginterferon 2a 40kDa) for Treatment of Chronic Hepatitis C
A Phase 2/3 study testing BIP 48 (Peginterferon alfa 2b 48kDA) and Peginterferon alfa 2a 40kDA in people with Chronic Hepatitis C, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- BIP 48 (Peginterferon alfa 2b 48kDA) and Peginterferon alfa 2a 40kDA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 740 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Dec 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Ufrgs/Hcpa
Porto Alegre, Rio Grande do Sul
Maria de Lourdes S. Maia, ASCLIN, 552138829479, mlourdes@bio.fiocruz.br
Vivian Rotman, ASCLIN, 552138829474, vivian.rotman@bio.fiocruz.br
About this study
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
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.
Read the 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 .
- Conditions
- Chronic Hepatitis C
- Being tested
- BIP 48 (Peginterferon alfa 2b 48kDA), Peginterferon alfa 2a 40kDA
- Keywords
- HEPATITIS, HEPATITIS C, PEGINTERFERON, BIOEQUIVALENCE, TREATMENT
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIP 48 (Peginterferon alfa 2b 48kDA)Drug
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.
Peginterferon alfa 2a 40kDADrug
Also called Pegasys ®
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.
BIP 48 (Peginterferon alfa 2b 48kDA)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pegasys ® | Active comparator | 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. Receives: Drug: BIP 48 (Peginterferon alfa 2b 48kDA); Drug: Peginterferon alfa 2a 40kDA |
| BIP 48 (Peginterferon alfa 2b 48kDA) | Experimental | Patients will receive BIP 48, 180 micrograms a week, SC, for the same period as Pegasys ®. Receives: Drug: BIP 48 (Peginterferon alfa 2b 48kDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of sustained virologic response - SVR - measured by PCR at 24 weeks after treatment.
Measured: 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
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.
Measured: 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 by quantitative PCR at the end of treatment.
Measured: Viral load will be measured at the end of treatment (week 24 for genotypes 2 and 3 and week 48 for genotype 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Paulo D. Picon, Invest, Principal investigator, Hospital de Clinicas de Porto AlegreGuilherme B. Sander, Coord, Study director, Hospital de Clinicas de Porto AlegreLuiz E. Mazzoleni, Coord, Study director, Hospital de Clinicas de Porto AlegreAndré C. Wortmann, Monitor, Study chair, NUCLIMEDKarine M. Amaral, Coordenação, Study chair, NUCLIMEDMarisa B. Costa, Sub Coord, Study chair, NUCLIMEDTobias C. Milbradt, Coord Log., Study chair, NUCLIMEDIndara C. Saccilotto, Coordenação, Study chair, NUCLIMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623336
- Sponsor's protocol ID
- 11/0468
- Acronym
- BIP48II/III
- Status last verified
- Nov 2011
- First submitted
- 13 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34307188
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01623336
- Acronym / sponsor ID
- BIP48II/III / 11/0468
- Conditions
- Chronic Hepatitis C
- Keywords
- HEPATITIS, HEPATITIS C, PEGINTERFERON, BIOEQUIVALENCE, TREATMENT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Study start
- Jan 2012
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegasys ® | Active comparator | Drug: BIP 48 (Peginterferon alfa 2b 48kDA), Drug: Peginterferon alfa 2a 40kDAPatients 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) | Experimental | Drug: BIP 48 (Peginterferon alfa 2b 48kDA)Patients will receive BIP 48, 180 micrograms a week, SC, for the same period as Pegasys ®. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 ;
Key exclusion criteria (27 listed)
- decompensated cirrhosis (Child-Pugh score> 6);
- history of bleeding gastroesophageal varices;
- hemoglobinopathies;
- hepatocellular carcinoma;
- co-infection with HIV or HBV;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Pegasys ® |
| Peginterferon alfa 2a 40kDAAlso: Pegasys ®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 | Pegasys ® |
| 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. | Drug | BIP 48 (Peginterferon alfa 2b 48kDA) |
Primary outcome
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)
2 secondary outcomes
Frequency of adverse events
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).
Virologic response 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Derived from this study: PubMed 34307188da 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo D. Picon, Invest principal investigator
Hospital de Clinicas de Porto Alegre
Guilherme B. Sander, Coord study director
Hospital de Clinicas de Porto Alegre
Luiz E. Mazzoleni, Coord study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BIP 48 (Peginterferon alfa 2b 48kDA) and Peginterferon alfa 2a 40kDA in people with Chronic Hepatitis C, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valeria Lucia de S. Gil, ASCLIN (552138827199, valeria.lucia@bio.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01623336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.