COURAGE Study

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.

Acronym of Public Title:

COURAGE

Scientific title:

Co-administration of EGF and GHRP-6 in patients with acute cerebral infarction of ischemic etiology.

Secondary indentifying numbers:

IG/CIGB-845I/IC/1601

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana. 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 Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Nayade

Last name:

Perez Rodriguez

Medical Specialty :

First Degree Specialist in General Medicine and Neurology

Affiliation:

University Hospital "Manuel Ascunce Domenech"

Postal address:

Carretera Central Oeste

City:

Camaguey

Country:

Cuba

Zip Code:

70100

Telephone:

+53-32231221

Email address:

nayade@mad.cmw.sld.cu [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:

Villa Clara, Universitary Hospital “Arnaldo Milian Castro”, Juan H. Gutierrez Ronquillo, 2nd Degree Specialist Neurology.

Villa Clara, General Hospital “Martires del 9 de Abril”, Julio A. Vega Cueva, 1st grade Specialist in Neurology.

Sancti Spiritus, General Hospital “Camilo Cienfuegos”, Javier J. Garcia Sacarias, 1st grade Specialist Internal Medicine.

Ciego de Avila, Provincial General Hospital “Dr. Antonio Luaces Iraola”, Carlos A. Casas Diaz, 1st grade Specialist in Neurology.

Las Tunas, Provincial General Hospital “Dr. Ernesto Che Guevara”, Melitza de la Caridad Pupo Machado, 1st grade Specialist in Neurology.

Holguin, Universitary Hospital “Vladimir Ilich Lenin”, Hansel Caballero Castellanos, 1st grade Specialist in General Medicine.

Holguin, Clinical Surgical Hospital "Lucia Iñiguez Landin", Ana M. Manzo Lopez, 1st grade Specialist Internal Medicine.

Granma, Universitary Hospital “Carlos Manuel de Cespedes”, Alexis Suarez Quesada, 1st grade Specialist Internal Medicine.

Granma, Clinical Surgical Hospital “Celia Sanchez Manduley”, Aliuska Castro Jerez, 1st grade Specialist Internal Medicine.

Santiago de Cuba, General Hospital “Dr. Juan Bruno Zayas Alfonso”, Elizabeth Lobaina Suarez, 1st grade Specialist Internal Medicine.

Santiago de Cuba, Provincial Hospital “Saturnino Lora”, Elizabeth Colina Avila, 1st grade Specialist in Neurology.

Guantanamo, General Hospital “Dr. Agostinho Neto”, Victor M. Rivas Gomez, 1st grade Specialist in Neurology.

Research ethics committees:

Universitary Hospital “Manuel Ascunce Domenech”, February 19, 2016.

Universitary Hospital “Arnaldo Milian Castro”, March 23, 2016.

General Hospital “Martires del 9 de Abril”, February 02, 2016.

General Hospital “Camilo Cienfuegos”, February 18, 2016.

Provincial General Hospital “Dr. Antonio Luaces Iraola”, February 08, 2016.

Provincial General Hospital “Dr. Ernesto Che Guevara”, April 01, 2016

Universitary Hospital “Vladimir Ilich Lenin”, March 24, 2016.

Clinical Surgical Hospital "Lucia Iñiguez Landin", March 30, 2016.

Universitary Hospital “Carlos Manuel de Cespedes”, January 21, 2016.

Clinical Surgical Hospital “Celia Sanchez Manduley”, January 28, 2016.

General Hospital “Dr. Juan Bruno Zayas Alfonso”, January 28, 2016.

Provincial Hospital “Saturnino Lora”, February 02, 2016.

General Hospital “Dr. Agostinho Neto”, January 25, 2016.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/09/2016

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:

Acute cerebral infarction of ischemic etiology

Health condition(s) code:

Cerebral Infarction

Brain Infarction

Brain Ischemia

Stroke

Cerebrovascular Disorders

Vascular Diseases

Cardiovascular Diseases

Brain Diseases

Central Nervous System Disease

Nervous System Diseases

Intervention(s):

It will be administered CIGB-845 (epidermal growth factor [EGF] combined with two dose levels of growth hormone releasing peptide [GHRP-6]). Group I (experimental): CIGB-845 (75 µg EGF + 3.5 mg GHRP-6) + conventional treatment. CIGB-845 will be administered intravenously, bolus, slowly for 3 minutes. The first dose will administer at the time of inclusion in the study and, then every 12 hours for 7 days (14 administrations in total). Group II (experimental): CIGB-845 (75 µg EGF + 7.0 mg GHRP-6) + conventional treatment. CIGB-845 will be administered intravenously, bolus, slowly for 3 minutes. The first dose will administer at the time of inclusion in the study and then every 12 hours for 7 days (14 administrations in total). Group III (control group): Conventional treatment. Conventional treatment include: stabilization of the patient (breathing and circulation), correction of water balance and electrolyte disturbances, strict control of vital signs, placing the patient supine with elevated head 30 degrees (treatment of cerebral edema), specific antibiotic therapy, maintaining glycemia below 150 mg / mL, maintain adequate oxygenation of the patient, among other general measures.

Intervention code:

Epidermal Growth Factor

Growth Hormone-Releasing Hormone

Peptides

Administration, Intravenous

Intervention keyword:

CIGB-845, recombinant Epidermal Growth Factor, GHRP-6

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 Adverse Events (AEs). The EA will be measured as -Occurrence of AEs (Yes, No), - AEs Description (name of event), - AEs Intensity (mild, moderate, severe). Measuring time: daily in Week 1 (time management starts CIGB-845) and at months 1, 3 and 6. Laboratory test (numerical values of blood chemistry tests: blood count, hematocrit, white blood cell count with differential, ALT, AST, glucose, creatinine, urea, uric acid, alkaline phosphatase, total protein, albumin, bilirubin, cholesterol, coagulogram and electrolytes). Measuring time: at baseline (before the first administration of CIGB-845), at 72 hours, at hospital discharge (7th day) and assessments for the months 1, 3 and 6.

Key secondary outcomes:

Disability (according to Rankin scale). Measuring time: at hospital discharge and at 3 and 6 months including the patient in the study. Neurologic deficit level (NIHSS scale, National Institute of Heath Stroke Scale). Measuring time: at hospital discharge and at 3 and 6 months post-inclusion. Ability to perform daily activities (according to Barthel index). Measuring time: at hospital discharge and at 3 and 6 months post-inclusion. Infarct volume (Computed Axial Tomography). Measuring time: the inclusion in the study, the 4th and the 7th day after starting 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:

80 years

Inclusion criteria:

1. Compliance with the diagnostic criteria (patients of both sexes with a focal neurologic defects caused by disturbances in blood supply to a particular brain area). 2. Age between 18 and 80 years, including both. 3. Time between onset of symptoms and start of administration of CIGB-845 less than 12 hours. 4. Willingness of the patient (or family) through the granting of informed consent (oral). In a second moment (once the patient is stabilized) the investigator must obtain the written consent of the patient, who may freely decide whether to accept or not to continue the investigation.

Exclusion criteria:

1. Coma (Glasgow Coma Scale less than 8). 2. Points in the NIHSS <5 or> 20 scale. 3. When the neurological defect can be explained by a different entity to ICA. 4. Patients with neurological symptoms or signs return to normal before treatment begins. 5. Severe uncontrolled hypertension (systolic> 185 mm Hg or diastolic BP> 110 mm Hg) not descend after treatment. 6. Low blood pressure (systolic <95 mm Hg) unresponsive to standard therapy. 7. Method of installation box with seizures. 8. Patients diagnosed with malignancies. 9. Pregnancy or breastfeeding at the time of inclusion in the study (reported by the patient or family). 10. Mental incapacity obvious to issue consent and act accordingly to the study.

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:

Active

Study design:

Parallel

Phase:

1-2

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:

Francisco

Last Name:

Hernandez Bernal

Specialty:

Doctor of Medical Sciences. 2nd Degree Specialist in Hygiene and Epidemiology.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, (53-7)-2087465

Email :

hernandez.bernal@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:

Francisco

Last Name:

Hernandez Bernal

Specialty:

Doctor of Medical Sciences. 2nd Degree Specialist in Hygiene and Epidemiology.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, (53-7)-2087465

Email :

hernandez.bernal@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:

RPCEC00000214

Date of Registration in Primary Registry:

27/05/2016

Record Verification Date:

2016/05/27

Next update date:

2017/05/27

Link to the spanish version:

Click here [3]