Status:
TERMINATED
The Duration Study
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy of epoetin alfa (PROCRIT®) administered subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRIT®) treatment in patients with cancer...
Detailed Description
The purpose of this study is to evaluate hematologic response in patients receiving epoetin alfa (PROCRIT®) therapy for persistent chemotherapy-induced myelosuppression (anemia) after completion of ch...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin value \>= 11 g/dL and \<= 12 g/dL unrelated to transfusion
- Female patients with reproductive potential must have a negative serum pregnancy test at screening. Patients must have signed an informed consent
Exclusion
- Uncontrolled hypertension
- History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
- Transfusion within 28 days prior to first dose
- Planned myelosuppressive chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00210730
Start Date
June 1 2004
End Date
July 1 2005
Last Update
June 10 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.