- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889849
Comparative Pharmacokinetics and Pharmacodynamics of Peginterferon BIP48 and 40kDa in Healthy Volunteers
June 28, 2013 updated by: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rio de Janeiro, Brazil, 21040-360
- Bio-Manguinhos/Fiocruz
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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;
- 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).
Exclusion Criteria:
- 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);
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BIP48
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.
|
Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
Other Names:
Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
Other Names:
|
Active Comparator: Pegasys
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.
|
Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
Other Names:
Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14 days + least 4 weeks (rest period between each administration) + 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paulo Dornelles Picon, Doctorate, Immunobiological Technology Institute (Bio-Manguinhos)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Costa 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
June 19, 2013
First Submitted That Met QC Criteria
June 28, 2013
First Posted (Estimate)
July 1, 2013
Study Record Updates
Last Update Posted (Estimate)
July 1, 2013
Last Update Submitted That Met QC Criteria
June 28, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis, Chronic
- Hepatitis
- Hepatitis C
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Peginterferon alfa-2a
- Peginterferon alfa-2b
Other Study ID Numbers
- ASCLIN 003/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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