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Comparative Pharmacokinetics and Pharmacodynamics of Peginterferon BIP48 and 40kDa in Healthy Volunteers

Primary Purpose

Chronic Viral Hepatitis C

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
BIP 48
Pegasys
Sponsored by
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Viral Hepatitis C

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Bio-Manguinhos/Fiocruz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIP48

Pegasys

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2013
Last Updated
June 28, 2013
Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
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1. Study Identification

Unique Protocol Identification Number
NCT01889849
Brief Title
Comparative Pharmacokinetics and Pharmacodynamics of Peginterferon BIP48 and 40kDa in Healthy Volunteers
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Viral Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIP48
Arm Type
Experimental
Arm Description
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.
Arm Title
Pegasys
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BIP 48
Other Intervention Name(s)
Peginterferon alfa 2b 48kDA
Intervention Description
Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Pegasys
Other Intervention Name(s)
Peginterferon alfa 2a 40kDA
Intervention Description
Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
Primary Outcome Measure Information:
Title
Safety Assessment
Description
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.
Time Frame
14 days + least 4 weeks (rest period between each administration) + 14 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Dornelles Picon, Doctorate
Organizational Affiliation
Immunobiological Technology Institute (Bio-Manguinhos)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bio-Manguinhos/Fiocruz
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil

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
PubMed Identifier
29301580
Citation
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.
Results Reference
derived

Learn more about this trial

Comparative Pharmacokinetics and Pharmacodynamics of Peginterferon BIP48 and 40kDa in Healthy Volunteers

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