EPOCIM in benign prostatic hyperplasia.

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:

Efficacy and safety of ior EPOCIM in reducing transfusion requirements in elective surgical patients with benign prostatic hyperplasia.

Secondary indentifying numbers:

IIC RD-EC096

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology

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 :

23/12/2008

Reference number:

05.011.08.B

Principal investigator

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

First name:

Carlos

Last name:

Ferrer La O

Medical Specialty :

Urology

Affiliation:

Saturnino Lora Hospital

Postal address:

Carretera Central N/n entre 4ta y 6ta Sueno

City:

Santiago de Cuba

País:

Cuba

Zip Code:

90100

Telephone:

+53-022622277

Email address:

ivis@cencec.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 City,Enrique Cabrera Hospital,MD.Roberto Milián Echavarría.First degree specialist in Urology.

Havana City, Joaquín Albarrán Hospital,MD.Alberto Elejalde Hernández.First degree specialist in Urology.

Havana City,Calixto García Hospital ,MD.Osvaldo Cantero. First degree specialist in Urology.

Villa Clara, Arnaldo Milián Castro Hospital, MD.Julio Vigil Quiñones. Second degree specialist in Urology.

Camagüey, Manuel Ascunce Domenech Hospital, MD. Juan Carlos Yip Felipe. First degree specialist in Urology.

Camagüey, María Curie Hospital, MD.Ranfis Rodríguez Bueno. First degree specialist in Urology.

Guantánamo, Agostinho Neto Hospital, MD.Gervasio Turcaz Alcolea. First degree specialist in Urology.

Santiago de Cuba, Juan Bruno Zayas General Hospital, MD.Santiago Duchases Olivares. First degree specialist in Urology.

Research ethics committees:

Havana City,Enrique Cabrera Hospital,October 17,2008.

Havana City, Hospital Joaquín Albarrán Hospital,October 22,2008.

Havana City, Calixto García Hospital,October 22,2008.

Villa Clara, Arnaldo Milián Castro Hospital,March 9,2009.

Camagüey, Manuel Ascunce Domenech Hospital,January 14,2009.

Camagüey, María Curie Hospital,October 14,2008.

Guantánamo, Agostinho Neto Hospital,December 22,2008.

Santiago of Cuba, General Juan Bruno Zayas Hospital,June 28,2008.

Santiago of Cuba, Provincial Saturnino Lora Hospital, June 20,2008.

Recruitment status

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

Recruitment status:

Suspended

Date of first enrollment:

15/05/2009

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:

Benign prostatic hyperplasia

Intervention(s):

Experimental group: - EPOCIM 40 000 IU (Bulbs 10 000 IU), subcutaneous (sc). A single dose weekly, prior to the scheduled date for surgery on days -21,-14,-7 and -1) - Oral supplement of ferrous fumarate, folic acid and polivit. Daily from day -21 to -1 before surgery. Control group: - Oral supplement of ferrous fumarate, folic acid and polivit. Daily from day - 21 to -1 before surgery. Ferrous fumarate (200 mg). One tablet daily away from meals Folic acid (5 mg). One tablet daily. Polivit. One tablet daily.

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):

- Transfusion requirements (yes/no). Measuring time: three days after surgery

Key secondary outcomes:

- Transfusion required (number of transfusions of blood that the patient required). Measurement Time: three days after surgery. - Hematological status (hemoglobin and hematocrit with the values recorded by the units in each institution). Measurement Time: days -21,-14,-7 and -1 before surgery and +1,+3 after surgery. - Hemodynamic status (blood pressure in mmHg and heart rate in beats/min). Measuring time: days -21,-14,-7 and -1 before surgery and +1, +3 after surgery. Adverse events (AE). Measurement time: three days after surgery. - Occurrence of AE (yes, no) - Description of AE (name of the adverse event is presented) - Duration of AE (difference between the start date and the end date of AE in minutes, hours or days) - Intensity of AE (1.Mild, 2.Moderate, 3.Severe, 4.Grave that the death of the subject, 5.Grave which threatens the life of the subject, 6.Grave requiring/prolonging hospitalization, 7.Grave producing disability/ significant disability or persistent, 8.Grave birth defect or congenital anomaly) - Severity of AE (Grave/serious, not Grave/not serious) - Attitude to the study treatment (unchanged, dose modification, temporary discontinuation of study treatment, permanent discontinuation of study treatment) - Result of AE (recovered, improved, persist, sequelae) - Causal link (1.Ultimately, 2.Very likely, 3.Likely, 4.Possible, 5.Not related, 6.Unknown)

Selection criterias

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

Gender:

Male

Minimum age:

19 years

Maximum age:

none

Inclusion criteria:

1.Patients who fulfill the diagnostic criteria. 2.Patients older than 18 years. 3.Patients give their informed consent to participate in writing.

Exclusion criteria:

1.Uncontrolled hypertension. 2.Patients with known risk or a history of arterial or venous thromboembolic disease. 3.Severe cardiovascular disease: unstable angina, heart failure, aortic stenosis. 4.Severe vascular brain disease. 5.Known infectious diseases such as HIV/AIDS,Hepatitis B and C. 6.Patients with known hypersensitivity to products derived from cells above or hypersensitivity to human albumin. 7.Hematologic Diseases:Sicklemia,Myelodysplastic syndromes,Disorders of coagulation. 8.Surgical approach to patients with benign prostatic hyperplasia by transurethral.

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:

3

Target sample size:

306

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:

Giselle

Last Name:

Saurez Martínez

Specialty:

Integral General Medicine and Pharmacology

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926 e/19 and 21 Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

(537)271-50-57 Etx.111

Email :

giselle@cim.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:

Giselle

Last Name:

Saurez Martínez

Specialty:

Integral General Medicine and Pharmacology

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926 e/19 y 21 Atabey,Playa.

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

(537)271-50-57 Ext.111

Email :

giselle@cim.sld.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:

RPCEC00000092

Date of Registration in Primary Registry:

2009-10-23

Record Verification Date:

2015/07/17

Next update date:

2016/07/17

Link to the spanish version:

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Proceso de Registro

EPOCIM in benign prostatic hyperplasia.

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