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InCarbacel-II
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:
Intralesional application of the CIGB-128 in the Basal cell carcinoma.
Secondary indentifying numbers:
IG/IAI-IGI/NB/9901
Issuing authority of the secondary identifying numbers:
Center for Genetic Engineering and Biotechnology (CIGB)
Primary sponsor:
Center for Genetic Engineering and Biotechnology (CIGB)
Secondary sponsor:
Ministry of Public Health, CUBA
Source(s) of monetary or material support:
Heber Biotec S.A.
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 :
21/11/2000
Reference number:
No. 10.
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Maria
Midle name:
Antonia
Last name:
Rodriguez Garcia
Medical Specialty :
II Degree Specialist in Dermatology
Affiliation:
"Hermanos Ameijeiras" Hospital
Postal address:
San Lázaro 701 corner 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:
“Hermanos Ameijeiras” Hospital, July 5th, 2000.
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
26/03/2001
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:
Skin basal cell carcinoma (BCC)
Health condition(s) code:
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Carcinoma
Skin Diseases
Intervention(s):
Intralesional treatment; three times per week for 3 weeks. After this time the patients that do not have complete response, will be receive it once a week until the response is achieved or they complete 11 weeks of treatment, according to the following scheme: Group I: Placebo + IFN alpha 2b recombinant Group II: Placebo + IFN gamma recombinant Group III: CIGB-128.
Intervention code:
Interferon-alpha
Interferon-gamma
Interferons
Injections, Intralesional
Placebos
Intervention keyword:
CIGB-128
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):
Clinical response (complete response, partial response, stable disease, progression). Time of measurement: 12 weeks of having started the treatment. Histological Response (cured or done not cure). Time of measurement: 12 weeks of having started the treatment.
Key secondary outcomes:
Time of response (months). Time of measurement: weekly for 12 weeks. Cosmetic results (good, regular, bad). Time of measurement: every three months for 2 years. Proportion of patients that have adverse reactions (percentage). Time of measurement: 2 years. Time until the relapse (months). Time of measurement: 2 years.
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:
None
Inclusion criteria:
Age equal or superior to 18 years. Informed consent given by the patient. Patients with clinical and histological diagnosis of B.C.C. Lesions of any clinical variant, location and color of the skin. Size of the lesion from 1 to 4 cm. No recurrent or recurrent previously treated disease.
Exclusion criteria:
Pregnant or lactating women. A history of hypersensitivity to interferon or any excipient in the study treatment. Acute or chronic hepatic disease (AST and ALT > 2 times upper limit of normal and/or serum total bilirubin >17 _mol/L). Acute or chronic renal disease. Uncompensated heart insufficiency.
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:
Double Blind
Control group:
Active
Study design:
Parallel
Phase:
2
Target sample size:
60
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:
Yanelda
Last Name:
García-Vega
Affiliation:
Center for Genetic Engineering and Biotechnology.(CIGB).
Postal Address:
Ave. 31 e/ 158 y 190 Cubanacan, Playa
City:
Havana
Country:
Cuba
Zip Code:
6162
Telephone:
(53-7)-2087377
Email :
yanelda.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:
Yanelda
Last Name:
García-Vega
Affiliation:
Center for Genetic Engineering and Biothecnology (CIGB).
Postal Address:
Ave. 31 e/ 158 y 190 Cubanacan, Playa
City:
Havana
Country:
Cuba
Zip Code:
6162
Telephone:
(53-7)-2087377
Email :
yanelda.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:
RPCEC00000066
Date of Registration in Primary Registry:
2010-12-28
Record Verification Date:
2010-06-08 20:00
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