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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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RPCEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RPCEC00000039 |
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Date of registration:
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07/10/2008 |
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Primary sponsor: |
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Public title:
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FarmaPEG-I
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Scientific title:
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Pharmacokinetics and pharmacodynamics comparison of two pegylated interferon alpha-2 formulations in healthy volunteers. |
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Date of first enrolment:
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20/05/2007 |
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Target sample size:
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16 |
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Recruitment status: |
Closed |
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URL:
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http://registroclinico.sld.cu/trials/RPCEC00000039-En |
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Study type:
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Interventional |
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Study design:
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Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Cross-over Purpose: Treatment
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Idrian MSc
García García |
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Address:
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31st Ave. between 158 and 190, Cubanacan, Playa, .
Havana City
Cuba |
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Telephone:
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(53-7)-2085887, 2087379. |
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Email:
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idrian.garcia@cigb.edu.cu |
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Affiliation:
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Center for Genetic Engineering and Biothecnology (CIGB), in Havana. |
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Name:
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Idrian MSc
García García |
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Address:
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31st Ave. between 158 and 190, Cubanacan, Playa.
Havana City
Cuba |
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Telephone:
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(53-7)-2085887, 2087379. |
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Email:
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idrian.garcia@cigb.edu.cu |
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Affiliation:
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Center for Genetic Engineering and Biothecnology (CIGB), in Havana. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Absence of antecedents from chronic diseases. 2. Absence of antecedents from acute diseases in the last 30 days. 3. Absence of symptoms and signs with the physical examination and laboratory test. 4. Seronegatives for HIV, hepatitis B and hepatitis C tests. 5. Voluntariness of the individual through the signing of the informed consent. 6.18-35 years of age. 7. Quetelet Index (19-29), (weight in kg, height in square meter). 8. Male.
Exclusion criteria: 1. Personal pathological antecedents from chronic diseases. 2. Individuals who have undergone treatment with some type of interferon in the last 30 days. 3. To refer some acute viral disease in the last 30 days. 4. To be under medication that can alter immunity. 5. Antecedents of allergy, idiosyncracy or hypersensitivity to a drug. 6. Surgery during the 6 previous months to the study initiation. 7. Blood donation three months before the study initiation. 8. Antecedents of alcoholism.
Age minimum:
18 years
Age maximum:
35 years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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None. Healthy volunteers.
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Intervention(s)
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180 micrograms single dose of Peg-interferon alfa-2, of one of the formulations studied will be administered subcutaneously into the deltoid region. The formulations under study are Pegasys (Hoffman-La Roche) and pegylated interferon (CIGB). The study measurement time will be 336 hours (14 days) in each treatment time.
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Primary Outcome(s)
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“Serum levels of pegylated IFN by EIA” and “Antiviral activity of the pegylated IFN” variables, measurement time: 336 hours.
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Secondary Outcome(s)
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1. ''Beta-2 micro globulin'', “2',5'-oligoadenylate synthetase'', and ''neopterin'' variables, measurement time: 336 hours. 2. “Safety of the treatment” variable, measurement time: 336 hours.
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Secondary ID(s)
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IG/IAPI/PK/0601
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Source(s) of Monetary Support
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Cuban Ministry of Public Health (MINSAP).
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