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NCT01809314 Clinical Trial

An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients Receiving Chemotherapy

Anemia Clinical Trial

Official title:
HUNGARIAN NON-INTERVENTIONAL STUDY TO OBSERVE THE TREATMENT OF SYMPTOMATIC ANAEMIA IN CANCER PATIENTS RECEIVING CHEMOTHERAPY AND NEORECORMON

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01809314
Other study ID # ML21420
Secondary ID
Status Completed
Phase N/A
First received March 8, 2013
Last updated February 1, 2016
Start date April 2008
Est. completion date February 2012

Study information
Verified date February 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Hungary: Medical Research Council
Study type Observational

Clinical Trial Summary

This observational study will evaluate the efficacy and safety of NeoRecormon (epoetin beta) in cancer patients receiving chemotherapy. Patients receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months.

Recruitment information / eligibility
Status Completed
Enrollment 645
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Patients with solid tumors or lymphoproliferative disease

- Patients receiving chemotherapy

- Patients for whom erythropoietin is indicated for pre-study hemoglobin level and observed anemic symptoms: Hgb < 11 dL (6.83 mmol/L)

Exclusion Criteria:

- Resistant hypertension

- Acute chronic bleeding within 3 months

- Iron deficiency, unmanageable prior to study

- Hypersensitivity to the active substance or any of the excipients of the product

- Pregnant or breast-feeding women

- Epoetin treatment within 6 months prior to study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in hemoglobin levels from baseline to end of treatment No
Secondary Number of transfusions given during study up to 4 months No
Secondary Change in Eastern Cooperative Oncology Group (ECOG) performance status from baseline to end of treatment No
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