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Study Complete
Sponsor ID
20020149

A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy who Have Completed the 20010103 Study

Sponsor ID
20020149
Clinicaltrials.gov ID
NCT00115167
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
371
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of adverse events

Timeframe: throughout study

Secondary Outcome Measures

Confirmed antibody formation to investigational product

Timeframe: throughout study

Deaths on study

Timeframe: on study

Laboratory parameters

Timeframe: throughout study

Vital signs (blood pressure)

Timeframe: throughout study

Change in PRO scores

Timeframe: from baseline to end of treatment

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Anemia
  • Cancer - Other
    • Sex
    All
    Trial Dates
    Aug 2004 - Jan 2007
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol
    Exclusion Criteria:
    - Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy - Subjects who have other diagnoses not related to the cancer which can cause anemia - Known history of seizure disorder - Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia - Uncontrolled hypertension - Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment - Subject of reproductive potential who is not using adequate contraceptive precautions - Concerns for subject's compliance with the protocol procedures