A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy

Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels, of Patients With Anemia Reklated to Malignant Tumors, Treated With Erythropoietin B (Recormon) Using the Pre-Filled Syringe With 30,000 IU, as Well as to Quantify Teh Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02624141

Enrollment

Registered

2015-12-08

Start date

2006-04-30

Completion date

2009-12-31

Last updated

2016-11-02

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

Conditions

Anemia

Brief summary

This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units \[IU\]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.

Interventions

DRUGEpoetin Beta

Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients with a non-myeloid malignancy * Anemia

Exclusion criteria

* Transfusion of red blood cells within 2 months of study drug * Treatment-resistant hypertension * Acute or chronic bleeding (requiring therapy) within 3 months of study drug

Design outcomes

Primary

Measure	Time frame
Hemoglobin Levels at 16 Weeks	16 Weeks

Secondary

Measure	Time frame
Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument	Up to 4 months
Tolerability - Incidence of Adverse Events	Up to 4 months
Serum Transferrin Levels	16 Weeks
Serum Iron Levels	16 Weeks
Time To Global Response	Up to 4 months
Quality of Life In Relation to Anemia Grade	Up to 4 months
Serum Ferritin Levels	16 Weeks
Percentage of Participants With A Positive Response	16 Weeks

Countries

Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026