Back to Search Results
Study Complete
Sponsor ID
20030125

Study for the Treatment of Anemia in Patients with Non-myeloid Malignancies Receiving Multicycle Chemotherapy.

Sponsor ID
20030125
Clinicaltrials.gov ID
NCT00148421
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Anemia
    • Sex
    All
    Trial Dates
    Jul 2003 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Subjects must provide written informed consent
    Exclusion Criteria:
    - Known history of seizure disorder - Known primary hematologic disorder causing anemia other than non-myeloid malignancies - Unstable / uncontrolled cardiac condition - Clinically significant inflammatory disease - Known positive test for HIV infection - Neutralizing antibodies to rHuEPO - Epoetin alfa or darbepoetin alfa therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - Pregnant or breast feeding - Not using adequate contraceptive precautions - Previously randomized into this study - Known hypersensitivity to recombinant mammalian-derived product - Concerns for subject's compliance