Impact of Recombinant Human Erythropoietin (ior EPO-CIM) in oncology pediatric patients with post chemo and /or radiotherapy.

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:

Impact of Recombinant Human Erythropoietin(ior EPO-CIM)in oncology pediatric patients with post chemo and /or radiotherapy.

Secondary indentifying numbers:

IIC RD-099

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Estatal

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 :

14/12/2004

Reference number:

In process

Principal investigator

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

First name:

Alejandro González Otero,MD.Senior Researcher.Second degree specialist in Hematology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

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:

Havana City,Juan Manuel Márquez Children´s Hospital,Ricardo Cabanas Armada,MD.Second degree specialist in Oncology. Havana City,William Soler Children´s Hospital,Caridad Verdecia Cannizares,MD.First degree specialist in Pediatric surgery. Pinar del Río,Pepe Portilla Children´s Hospital,Bárbara Iglesias,MD.First degree specialist in Oncology. Villa Clara,José Luis Miranda Children´s Hospital,Tamara Cedré Hernández,MD.First degree specialist in Hematology. Holguín,Province Hospital Children´s Octavio de la Concepción y de la Pedraja,René Núñez Inza,MD.First degree specialist in Pediatrie. Santiago de Cuba,South Province Children´s Hospital,Odis Taquechel,MD.Second degree specialist in Pediatrie.

Research ethics committees:

Havana City,William Soler Children´s Hospital,September 9,2004. Havana City,Juan Manuel Márquez Children´s Hospital,November 26,2004. Havana City,Hematology and Inmunology Institute,November 15,2004. Pinar del Río,Pepe Portilla Children´s Hospital,January 25,2005. Villa Clara,José Luis Miranda Children´s Hospital,July 20,2004. Holguín,Province Hospital Children´s Octavio de la Concepción y de la Pedraja,August 20,2004. Santiago de Cuba,South Province Children´s Hospital,September 1,2004.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

15/12/2004

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:

Anemia secondary to chemo and/or radiotherapy.

Intervention(s):

EPOCIM(EPO):600 IU/kg (intravenous route) single weekly dose,or 150 IU/kg(subcutaneously),3 times a week, managing a maximum of 40 000 UI/week for 8 weeks .

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):

Value of Hemoglobin in g / l at the beginning of treatment and at the 8th week.

Key secondary outcomes:

Recovery time of the hemoglobin values(g/l). Measurement time:8 weeks. occurrence of any adverse event in the subject,intensity of adverse events,adverse events description. Measurement time:8 weeks. Number of transfusions received during the previous 2 months and weekly during 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:

1 years

Maximum age:

18 years

Inclusion criteria:

1.Patients that fulfill with diagnostic criteria. 2.Patients with cytological and/or histological diagnosis of cancer of any localization that are receiving chemotherapy and/or radiotherapy. 3.Patients whose parents or tutors granted written consent for participation in the study. 4.Patients aged between 1 and 18 years.

Exclusion criteria:

1.Patients with known hypersensitivity to products derived from mammalian cells or hypersensitivity to human albumin. 2.Patients pregnant or breastfeeding. 3.Patients with active hemorrhage or hemolysis. 4.Patients with non-controlled arterial hypertension.

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:

Single group

Phase:

4

Target sample size:

161

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:

MD.Giselle

Last Name:

Saurez

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 Ext.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:

MD.Giselle

Last Name:

Saurez

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 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:

RPCEC00000080

Date of Registration in Primary Registry:

2009-07-03

Record Verification Date:

2009-06-26 20:00

Link to the spanish version:

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Ensayos Registrados

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Impact of Recombinant Human Erythropoietin (ior EPO-CIM) in oncology pediatric patients with post chemo and /or radiotherapy.

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