FarmaPEG-I

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Pharmacokinetics and pharmacodynamics comparison of two pegylated interferon alpha-2 formulations in healthy volunteers.

Secondary indentifying numbers:

IG/IAPI/PK/0601

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Cuban Ministry of Public Health (MINSAP).

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

06/12/2006

Reference number:

3006/11.030.06.B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Carlos

Midle name:

Alberto

Last name:

González Delgado

Medical Specialty :

Specialist I Degree in Pharmacology

Affiliation:

National Center for Toxicology (CENATOX).

Postal address:

Avenida 31 y 114

City:

Havana

País:

Cuba

Zip Code:

11400

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Ethics Committee from CENATOX: April 11th 2006.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

20/05/2007

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

None. Healthy volunteers.

Health condition(s) code:

Healthy Volunteers

Intervention(s):

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.

Intervention code:

Interferon-alpha

Interferons

Injections, Subcutaneous

Intervention keyword:

Peginterferon alpha-2

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

“Serum levels of pegylated IFN by EIA” and “Antiviral activity of the pegylated IFN” variables, measurement time: 336 hours.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male

Minimum age:

18 years

Maximum age:

35 years

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.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Crossover

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Idrian

Last Name:

García García

Specialty:

Degree in Pharmacy

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB)

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087379.

Email :

idrian.garcia@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Idrian

Last Name:

García García

Specialty:

Degree in Pharmacy

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB)

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa, .

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087379.

Email :

idrian.garcia@cigb.edu.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000039

Date of Registration in Primary Registry:

2008-10-07

Record Verification Date:

2008-10-01 20:00

Link to the spanish version:

Click here [3]