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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000080
Enrollment
161
Registered
2009-07-03
Start date
2004-12-15
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia secondary to chemo and/or radiotherapy.

Interventions

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 .

Sponsors

Center of Molecular Immunology(CIM)
Lead Sponsor
No proceed
Collaborator

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion 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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Cuba

Contacts

Public ContactMD.Giselle Saurez

CIMAB S.A

giselle@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026