Chronic Viral Hepatitis CPhase 1NCT01889849
Comparative Pharmacokinetics and Pharmacodynamics of Peginterferon BIP48 and 40kDa in Healthy Volunteers
A Phase 1 study testing BIP 48 and Pegasys in people with Chronic Viral Hepatitis C, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial summary
This research protocol "Comparative pharmacokinetics and pharmacodynamics of peginterferon Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy volunteers." This is a Phase I clinical trial which will compare pharmacokinetic and pharmacodynamic parameters, and safety of two… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Viral Hepatitis C
- What is being tested?
- BIP 48 and Pegasys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Aug 2011
- Phase
- Phase 1
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No history of chronic diseases;
- Preserved oral health;
- No history of acute illness in the last 30 days;
- Absence of significant clinical symptoms and signs on physical examination;
- laboratory tests within normal limits;
- imaging tests within normal limits;
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- Seronegative tests for HIV and B and C Hepatitis; Signing the consent form;
- Male;
- Age between 18 and 35 years;
- Body mass index between 19 and 26 (weight in kg / height in meters squared).
Who cannot join
- Patients with hypersensitivity to Interferon alpha, Escherichia coli-derived products, polyethylene glycol (macrogol), or any constituent salts of these preparations.
- Individuals treated with some type of interferon at any time, prior to the present research.
- History of chronic diseases such as autoimmune diseases, liver failure, decompensated cirrhosis, heart disease, renal failure, diabetes mellitus, thyroid diseases, hemoglobinopathies, cytopenias, history of psychiatric disease, retinopathy, optic neuritis.
- History of acute viral disease in the last 30 days;
- Current use of medications that alter immunity: corticosteroids, immunosuppressants;
- History of known allergy to drugs, including interferon or to any component of the product (at the discretion of the investigator);
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- Having undergone surgery during the 6 months prior to study entry; Had donated blood three months prior to study entry;
- History of alcoholism or current use of alcohol;
- Use of other illicit drugs in the past 6 months;
- Participation in a clinical study with previous therapeutic intervention in the year prior to inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Pharmacokinetics and Pharmacodynamics, and Safety of Two Products Containing Recombinant Human Interferon Alpha-2 Conjugated to Polyethylene Glycol in Healthy Volunteers - Phase 1.
This research protocol "Comparative pharmacokinetics and pharmacodynamics of peginterferon Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy volunteers." This is a Phase I clinical trial which will compare pharmacokinetic and pharmacodynamic parameters, and safety of two products: peginterferon alfa-2a (PEGASYS ®) and BIP48. It will be a double-blind, randomized crossover with a rest period (wash-out) of 4 weeks. The study population will be 32 healthy male volunteers to whom will be administered a single dose of 180 microgram of each product, subcutaneously. The study will have a total duration of 14 days in each treatment step. The serum concentration of PEG-interferon for both products, measured by enzyme immunoassay (EIA) and by antiviral activity of PEG-interferon, is the main variable.For this purpose 15 samples of each volunteers will be needed. Clinical and laboratory variables, useful as pharmacodynamics parameters Beta-2 microglobulin (β2M) - 2'5'oligoadenylate synthetase - oligoadenylate synthetase (OAS)- and neopterin) and safety evaluation, will be measured.
Read the detailed description
Double-blind study, ie, the volunteers and the study team will not be aware of the product administered. As the presentations of the two products are different, only the professional who will administer the injections will not be blinded, and will not have contact with volunteers or members of the study team after applying the medication.
- Conditions
- Chronic Viral Hepatitis C
- Being tested
- BIP 48, Pegasys
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIP 48Drug
Also called Peginterferon alfa 2b 48kDA
Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
PegasysDrug
Also called Peginterferon alfa 2a 40kDA
Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BIP48 | Experimental | Will be recruited for the study 32 volunteers, all of whom will receive two products in two stages separated by at least 4 weeks. Volunteers will be randomized into 2 groups of 16 and at the time of the intervention, the volunteer will receive product application labeled with its corresponding number. The second step in the product administered will necessarily be one that contains the number and it was not administered in the first step. Receives: Drug: BIP 48; Drug: Pegasys |
| Pegasys | Active comparator | Will be recruited for the study 32 volunteers, all of whom will receive two products in two stages separated by at least 4 weeks. Volunteers will be randomized into 2 groups of 16 and at the time of the intervention, the volunteer will receive product application labeled with its corresponding number. The second step in the product administered will necessarily be one that contains the number and it was not administered in the first step. Receives: Drug: BIP 48; Drug: Pegasys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
Evaluation of safety will be estimated by the analysis of clinical chemistry and hematology (CBC and transaminase) prior to study initiation and at 24, 48, 72, 96, 120, 168 and 336 hours after administration of peginterferon alpha, in each treatment period.
Measured: 14 days + least 4 weeks (rest period between each administration) + 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Viral 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulo Dornelles Picon, Doctorate, Principal investigator, Immunobiological Technology Institute (Bio-Manguinhos)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889849
- Sponsor's protocol ID
- ASCLIN 003/2009
- Status last verified
- Jun 2013
- First submitted
- 19 Jun 2013
- Last updated
- 1 Jul 2013
- 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 34307188Costa MB, Picon PD, Sander GB, Cuni HN, Silva CV, Meireles RP, Goes ACMA, Batoreu NM, Maia MLS, Albuquerque EM, Matos DCS, Saura PL. Pharmacokinetics comparison of two pegylated interferon alfa formulations in healthy volunteers. BMC Pharmacol Toxicol. 2018 Jan 4;19(1):1. doi: 10.1186/s40360-017-0192-z.
PubMed 29301580
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics and Pharmacodynamics, and Safety of Two Products Containing Recombinant Human Interferon Alpha-2 Conjugated to Polyethylene Glycol in Healthy Volunteers - Phase 1.
- ClinicalTrials.gov ID
- NCT01889849
- Acronym / sponsor ID
- ASCLIN 003/2009
- Conditions
- Chronic Viral Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Jul 2013 (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.
This research protocol "Comparative pharmacokinetics and pharmacodynamics of peginterferon Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy volunteers." This is a Phase I clinical trial which will compare pharmacokinetic and pharmacodynamic parameters, and safety of two products: peginterferon alfa-2a (PEGASYS ®) and BIP48. It will be a double-blind, randomized crossover with a rest period (wash-out) of 4 weeks. The study population will be 32 healthy male volunteers to whom will be administered a single dose of 180 microgram of each product, subcutaneously. The study will have a total duration of 14 days in each treatment step. The serum concentration of PEG-interferon for both products, measured by enzyme immunoassay (EIA) and by antiviral activity of PEG-interferon, is the main variable.For this purpose 15 samples of each volunteers will be needed. Clinical and laboratory variables, useful as pharmacodynamics parameters Beta-2 microglobulin (β2M) - 2'5'oligoadenylate synthetase - oligoadenylate synthetase (OAS)- and neopterin) and safety evaluation, will be measured.
Detailed description
Double-blind study, ie, the volunteers and the study team will not be aware of the product administered. As the presentations of the two products are different, only the professional who will administer the injections will not be blinded, and will not have contact with volunteers or members of the study team after applying the medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIP48 | Experimental | Drug: BIP 48, Drug: PegasysWill be recruited for the study 32 volunteers, all of whom will receive two products in two stages separated by at least 4 weeks. Volunteers will be randomized into 2 groups of 16 and at the time of the intervention, the volunteer will receive product application labeled with its corresponding number. The second step in the product administered will necessarily be one that contains the number and it was not administered in the first step. |
| Pegasys | Active comparator | Drug: BIP 48, Drug: PegasysWill be recruited for the study 32 volunteers, all of whom will receive two products in two stages separated by at least 4 weeks. Volunteers will be randomized into 2 groups of 16 and at the time of the intervention, the volunteer will receive product application labeled with its corresponding number. The second step in the product administered will necessarily be one that contains the number and it was not administered in the first step. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- No history of chronic diseases;
- Preserved oral health;
- No history of acute illness in the last 30 days;
- Absence of significant clinical symptoms and signs on physical examination;
- laboratory tests within normal limits;
Key exclusion criteria (10 listed)
- Patients with hypersensitivity to Interferon alpha, Escherichia coli-derived products, polyethylene glycol (macrogol), or any constituent salts of these preparations.
- Individuals treated with some type of interferon at any time, prior to the present research.
- History of chronic diseases such as autoimmune diseases, liver failure, decompensated cirrhosis, heart disease, renal failure, diabetes mellitus, thyroid diseases, hemoglobinopathies, cytopenias, history of psychiatric disease, retinopathy, optic neuritis.
- History of acute viral disease in the last 30 days;
- Current use of medications that alter immunity: corticosteroids, immunosuppressants;
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 48Also: Peginterferon alfa 2b 48kDAVolunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks. | Drug | BIP48, Pegasys |
| PegasysAlso: Peginterferon alfa 2a 40kDAVolunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks. | Drug | BIP48, Pegasys |
Primary outcome
Safety Assessment
Time frame: 14 days + least 4 weeks (rest period between each administration) + 14 days
Evaluation of safety will be estimated by the analysis of clinical chemistry and hematology (CBC and transaminase) prior to study initiation and at 24, 48, 72, 96, 120, 168 and 336 hours after administration of peginterferon alpha, in each treatment period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
- 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.
- Derived from this study: PubMed 29301580Costa MB, Picon PD, Sander GB, Cuni HN, Silva CV, Meireles RP, Goes ACMA, Batoreu NM, Maia MLS, Albuquerque EM, Matos DCS, Saura PL. Pharmacokinetics comparison of two pegylated interferon alfa formulations in healthy volunteers. BMC Pharmacol Toxicol. 2018 Jan 4;19(1):1. doi: 10.1186/s40360-017-0192-z.
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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 Dornelles Picon, Doctorate principal investigator
Immunobiological Technology Institute (Bio-Manguinhos)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIP 48 and Pegasys in people with Chronic Viral 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 1 Jul 2013. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (time frame: 14 days + least 4 weeks (rest period between each administration) + 14 days). 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 NCT01889849, which also lists 2 linked publications.
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 1 Jul 2013.