Home
Login
Help
Search this site:
Registered Trials
By recruitment status
By sponsor
By registration date
Advanced search for trials
Registration process
To register a trial
Sponsor registration form
RPCEC trial registration Data Set
To update a registered trial
To disclosure the results of registered trial
Home
|
Biomodulin T Intramuscular for Thymus Hypoplasia in Children. Phase III
View current
Revisions
Comparing two revisions:
15 April 2020 - 4:32pm
by BIOCEN
19 July 2023 - 3:45pm
by Gladys
< previous diff
Changes to
Secondary indentifying numbers
-
DEC-BMT201702
+
GEC2017BMT018
Current revision:
Biomodulin T Intramuscular for Thymus Hypoplasia in Children. Phase III
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:
Evaluation of the efficacy and safety of Biomodulin T in pediatric patients with thymic hypoplasia associated or not with cellular immunodeficiency. Clinical Trial Phase III. Version 0.1.
Secondary indentifying numbers:
GEC2017BMT018
Issuing authority of the secondary identifying numbers:
Center National of Bioproducts (BioCen)
Primary sponsor:
Center National of Bioproducts (BioCen)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Center National of Bioproducts (BioCen)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 Drugs, Medical Devices and Equipment (CECMED)
Authorization date :
10/05/2018
Reference number:
672/05.012.17.BNV
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Odalis
Midle name:
Maria
Last name:
de la Guardia Peña
Medical Specialty :
Specialist of 2nd. Degree in Immunology
Affiliation:
Institute of Hematology and Immunology (IHI)
Postal address:
19th between 8 and 10, Vedado
City:
Plaza de la Revolución, La Habana
Country:
Cuba
Zip Code:
10800 Box 8070
Telephone:
+53-7846115
Email address:
odalism@infomed.sld.cu
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:
Havana, "William Soler" Pediatric Hospital, MD. Concepción Insua Arregui, Specialist of 2nd Degree in Imaging
Research ethics committees:
Institute of Hematology and Immunology, January 25, 2019
"William Soler" Pediatric Hospital, January 25, 2019
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Recruiting
Date of first enrollment:
03/12/2018
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:
Thymus hypoplasia
Health condition(s) code:
Thymus Gland /abnormalities
Health condition keyword:
Thymic Hypoplasia
Intervention(s):
Patients will receive treatment with Biomodulin T via IM. The doses of one, two or three bulb per week will be differentiated according to the degree of Hypoplasia: Severe Thymic Hypoplasia (STH), Moderate (MTH) and Light (HTL): 1. Scheme 1. Subgroup I without cellular immunodeficiency ) Week 1 to 4: 1 bulb (3 mg of timic fraction) IM, biweekly (3 mg) (First cycle) Week 5 to 8: Rest Week 9 to 12: 1 bulb (3 mg) IM, once a week (3 mg) (Second cycle) Week 13 to 16: Rest Week 17 to 24: 1 bulb (3 mg) IM, once a week (3 mg) (Third cycle) Week 25 to 32: Rest 2. Scheme 2. Subgroup I without cell immunodeficiency (HTM): Week 1 to 4: 1 bulb (3 mg) IM, once a week (3 mg) (first cycle) Week 5 to 8: Rest Week 9 to 12: 1 bulb (3 mg) IM, once a week (3 mg) (Second cycle) Week 13 to 16: Rest Week 17 to 24: 1 bulb IM, once a week (3 mg) (Third cycle) Week 25 to 32: Rest 3. Scheme 3. Subgroup II with cell immunodeficiency (HTS): Week 1 to 4: 1 bulb (3 mg) IM, 3 times per week (9 mg) (First cycle) Week 5 to 8: Rest Week 9 to 12: 1 bulb (3 mg) IM, biweekly (6 mg) (Second cycle) Week 13 to 16: Rest Week 17 to 24: 1 bulb (3 mg) IM, biweekly (6 mg) (Third cycle) Week 25 to 32: Rest 4. Scheme 4. Subgroup II with cell immunodeficiency (HTM): Week 1 to 4: 1 bulb (3 mg) IM, biweekly (6 mg) (First cycle) Week 5 to 8: Rest Week 9 to 12: 1 bulb (3 mg) IM, once a week (3 mg) (Second cycle) Week 13 To 16: Rest Week 17 to 24: 1 bulb (3 mg) IM, once a week (3 mg) (Third cycle) Week 25 to 32: Rest 5. Scheme 5. Subgroup II with cellular immunodeficiency (HTL): Week 1 to 4: 1 bulb (3 mg) IM, once a week (3 mg) (First cycle) Week 5 to 8: Rest Week 9 to 12: 1 bulb (3 mg) IM, once a week (3 mg) (Second cycle) Week 13 to 16: Rest Week 17 to 24: 1 bulb (3 mg) IM, once a week (3 mg) (Third cycle) Week 25 to 32: Rest The first and second cycle of treatment will be administered in all cases. The third cycle will be administered if after the ultrasonographic evaluation of the thymus, it is shown that the area of this, still does not reach its normal value.
Intervention code:
Immunologic Factors
Immunomodulation
Injections, Intramuscular
Intervention keyword:
Biomodulin T
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):
1. Thymic Area (Ultrasound measurement of thymus in mm2). Measurement time: At baseline, 16 weeks and 32 weeks if you complete the third cycle. 2. Degree of thymic hypoplasia (Classification of degree of thymic hypoplasia according to scale in light, moderate or severe). Measurement time: At baseline, 16 weeks and 32 weeks if patient receives the third cycle.
Key secondary outcomes:
1. Infections (Number of infections in the period). Measurement time: At baseline, 16 weeks and 32 weeks if you complete the third cycle. 2. Nutritional Status (Body Mass Index-BMI). Measurement time: At baseline, 16 weeks and 32 weeks if you complete the third cycle. 3. Lymphocyte Subpopulations (Percent of Lymphocyte Markers by Flow Cytometry- CD3+/CD4+, CD3+/CD8+, CD19+, CD56+). Measurement time: At baseline, 16 weeks and 32 weeks if you complete the third cycle . 4. Quality of life (PedsQL Version 4.0 in Spanish Quality of Life questionnaire). Measurement time: At baseline, 16 weeks and 32 weeks if you complete the third cycle. 5. Adverse events-AE (Occurrence of some AE (Yes, No), Description of the AE (Name of adverse event),According to available previous information (Unexpected, Expected), According to its localization the expected AE (World Allergy Organization Criterion: local and systemic AE (0= Nonspecific Symptoms, I= Mild systemic reactions, II= Moderate systemic reactions, III= Severe (nonlife-threatening) systemic reactions, IV= Anaphylactic shock)), Duration of the AE (Time between the start and the end of the AE), Graveness of the AE (Serious, No serious), Attitude regarding the treatment in study (Without changes, Dose modification, Temporary interruption, Definitive interruption), Result of the AE (Recovered, Improved, Persists, Sequels), Causality Relationship of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated)). Measurement time: weekly during the first month and, monthly until month 12.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
1 year
Maximum age:
5 years
Inclusion criteria:
1. Patients with radiological confirmation by Thymus Ultrasound of Severe, Moderate or Light Thymic Hypoplasia with or without clinical manifestations of immunodeficiencies 2. Both sexes between the ages of one and five years. 3. That they are virgins of immunostimulating or immunosuppressive treatment, at least during the previous 6 months. 4. Voluntariness of the patient's parent or guardian and giving written informed consent.
Exclusion criteria:
1. Patients with a history of severe allergic reactions and / or severe generalized eczema. 2. Patients with any other type of non-cellular immunodeficiency with exception of IgA partial deficiency. 3. Di George Syndrome. 4. Patients who have been treated with steroids in the previous 45 days. 5. Patients with a diagnosis of tumor or autoimmune disease of any kind. 6. Patients with chronic diseases of the type Diabetes Mellitus Type I or any other endocrinopathy. 7. Patients with severe congenital malformations that cause disability or require medical or surgical treatment. 8. Patients with hemoglobin lower than 9 g/L.
Type of population:
Children
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
Non-randomized controlled trial
Masking:
Open
Control group:
Uncontrolled
Study design:
Parallel
Phase:
3
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:
Odalis
Middle Name:
María
Last Name:
de la Guardia Peña
Specialty:
Specialist of Second Degree in Immunology
Affiliation:
Institute of Hematology and Immunology
Postal Address:
19th between 8 and 10, Vedado
City:
Plaza de la Revolución, Cuba
Country:
Cuba
Zip Code:
13050, Box 6048
Telephone:
+53-7846115
Email :
odalism@infomed.sld.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:
Mary
Middle Name:
Carmen
Last Name:
Reyes Zamora
Specialty:
Specialist of First Degree in Immunology, Master in Clinical Trials
Affiliation:
Department of Clinical Trials, National Center of Bioproducts (BioCen)
Postal Address:
Carretera de Beltran Km 1 ½ S/N
City:
Bejucal, Mayabeque
Country:
Cuba
Zip Code:
13050, Box 6048
Telephone:
+53047-066-82201 al 07, Ext.: 1145 and 1147
Email :
mcarmen.reyes@biocen.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
Not entered
About study completion
Section to complete the data related to the study completion.
Final enrolment number:
30/12/2019
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:
RPCEC00000247
Date of Registration in Primary Registry:
14/08/2017
Record Verification Date:
2020/04/15
Next update date:
2021/04/15
Link to the spanish version:
Click here
About the RPCEC
Structure and governance
Policy
Publications
Awards
Communications
News
Useful resources
Fundamentals of the registry
References of clinical trials
Cuban regulations
Other registries
International Clinical Trials Registry Platform