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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000080
• Date of registration: 03/07/2009
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: Impact of Recombinant Human Erythropoietin (ior EPO-CIM) in oncology pediatric patients with post chemo and /or radiotherapy.
• Scientific title: Impact of Recombinant Human Erythropoietin(ior EPO-CIM)in oncology pediatric patients with post chemo and /or radiotherapy.
• Date of first enrolment: 15/12/2004
• Target sample size: 161
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000080-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: MD.Giselle Saurez
• Affiliation: CIMAB S.A

• Name: MD.Giselle Saurez
• Affiliation: CIMAB S.A

Key inclusion & exclusion criteria

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.

Age minimum: 1 years
Age maximum: 18 years
Gender: Both

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 .

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Secondary ID(s)

IIC RD-099

Source(s) of Monetary Support

Estatal

Secondary Sponsor(s)

No proceed