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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02624141
• Other study ID #: ML18054
• Status: Terminated
• Phase: Phase 4
• First received: December 2, 2015
• Last updated: November 1, 2016
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Institutional Ethical Committe and Health Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Epoetin 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin Levels at 16 Weeks		16 Weeks	No
Secondary	Serum Iron Levels		16 Weeks	No
Secondary	Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument		Up to 4 months	No
Secondary	Tolerability - Incidence of Adverse Events		Up to 4 months	No
Secondary	Serum Transferrin Levels		16 Weeks	No
Secondary	Percentage of Participants With A Positive Response		16 Weeks	No
Secondary	Time To Global Response		Up to 4 months	No
Secondary	Quality of Life In Relation to Anemia Grade		Up to 4 months	No
Secondary	Serum Ferritin Levels		16 Weeks	No