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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00083434
Other study ID # CR010549
Secondary ID EPO-CAN-303
Status Terminated
Phase Phase 3
First received May 24, 2004
Last updated April 25, 2011
Start date February 2004
Est. completion date October 2004

Study information

Verified date April 2011
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date October 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- Body weight >/= 99lbs

- ECOG 0-2

- Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy

- Screening hemoglobin level of </= 11.0 g/dL for men or </= 10.0 for women

Exclusion Criteria:

- History of or concurrent second malignancy

- Evidence of primary or metastatic malignancy involving the Central Nervous System

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Epoetin alfa


Locations

Country Name City State
United States Advanced Urology Medical Center Anaheim California
United States Shapiro, Stafford & Yee Arcadia California
United States California Cancer Center Fresno California
United States Tukoi Research North Miami Florida
United States Madigan Army Medical Center Urology Services Tacoma Washington
United States Hanover Medical Specialists, PA Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

United States, 

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