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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:

Intramuscular application of a new freeze-dried formulation of albumin-free recombinant human alpha-2b interferon in Acuminate Condyloma patients.

Secondary indentifying numbers:

IG/IAI/PD/0301

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Ministry of Public Health, CUBA

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 :

07/05/2003

Reference number:

291/02.005.03.B

Principal investigator

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

First name:

Sonia

Last name:

Collazo Caballero

Medical Specialty :

Specialist of 2nd degree in Dermatology

Affiliation:

Ameijeiras Clinical-Surgical Hospital

Postal address:

San Lázaro 701 entre Marquez Glez y Belascoain

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761000

Email address:

email@not.entered

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:

Ameijeiras Clinical-Surgical Hospital, April 11, 2003

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

22/04/2003

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:

Acuminate Condyloma

Health condition(s) code:

Condylomata Acuminata

Warts

Papillomavirus Infections

DNA Virus Infections

Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases

Skin Diseases, Viral

Tumor Virus Infections

Virus Diseases

Skin Diseases, Infectious

Skin Diseases

Intervention(s):

Group I. One daily intramuscular application of 10x106 UI of the product under study for 2 consecutive days. Group II. One daily intramuscular application of 5x106 UI of the product under study for 4 consecutive days. Group III. One daily intramuscular application of 3x106 UI of the product under study for 7 consecutive days. The three groups will thus receive practically the same weekly dosage of 20x106 UI.

Intervention code:

Interferon-alpha

Interferons

Injections, Intramuscular

Intervention keyword:

recombinant human alpha-2b interferon

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):

Beta-2 microglobulin level, measuring time: before and after treatment. 2.5 oligoadenylate synthetase level, measuring time: before and after treatment.

Key secondary outcomes:

Size of lesions (greater and lesser diameters), measuring time: before and after treatment. Number of lesions, measuring time: before and after treatment. Need for other conventional treatments, measuring time: before and after treatment.

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

60 years

Inclusion criteria:

Clinical and histological diagnosis positive to Acuminate Condyloma by papilloma virus. Patients of both sexes with Acuminate Condyloma lesions in external genitals, perianal region, and inner thighs. Patients aged 18 to 60. No topical or systemic treatment with IFN or any other antiviral drug one month before inclusion in the study. Reproductive-age women using any non-hormonal contraceptive. Patient’s consent in writing to participate in the study.

Exclusion criteria:

Other sexually transmitted diseases (syphilis, infectious urethritis, AIDS). Antiviral or immunosuppressor (corticosteroid, cytostatic) therapy three months before commencing INF treatment. Severe systemic and chronic diseases affecting the patient’s general condition and modifying therapeutic response, including malignant neoplasias and immunodeficiency. Lesion sepsis demanding systemic antibiotic treatment. Pregnancy or breastfeeding. Patients with history of hypersensitivity to alpha INF or any formulation component.

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

2

Target sample size:

30

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:

Garcia Garcia

Specialty:

Degree in Pharmacy

Affiliation:

Biological Researches Center, Clinical Trials Division

Postal Address:

134 street, between 23 and 25 street. Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)- 2087379

Email :

idrian.garcia@cigb.edu.cu

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:

Garcia Garcia

Specialty:

Degree in Pharmacy

Affiliation:

Biological Researches Center, Clinical Trials Division

Postal Address:

134 street, between 23 and 25 street. Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)- 2087379

Email :

idrian.garcia@cigb.edu.cu

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:

RPCEC00000038

Date of Registration in Primary Registry:

2010-12-20

Record Verification Date:

2008-02-04 19:00

Link to the spanish version:

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