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

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ClinicalTrials.gov Identifier: NCT01889849
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : July 1, 2013
Sponsor:
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Viral Hepatitis C Drug: BIP 48 Drug: Pegasys Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

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Arms and Interventions
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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.
 Drug: BIP 48
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 Name: Peginterferon alfa 2b 48kDA

Drug: Pegasys
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 Name: Peginterferon alfa 2a 40kDA
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.
 Drug: BIP 48
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 Name: Peginterferon alfa 2b 48kDA

Drug: Pegasys
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 Name: Peginterferon alfa 2a 40kDA


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889849


Locations
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Brazil
Bio-Manguinhos/Fiocruz
Rio de Janeiro, Brazil, 21040-360
Sponsors and Collaborators
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Investigators
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Principal Investigator: Paulo Dornelles Picon, Doctorate Immunobiological Technology Institute (Bio-Manguinhos)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT01889849    
Other Study ID Numbers: ASCLIN 003/2009
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepatitis, Viral, Human
 Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents