A Phase 4 interventional study of Epoetin Beta in Anemia, sponsored by Hoffmann-La Roche. Terminated at 2 sites in Venezuela. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is 4 months, and the target sample size is 30 individuals.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 4 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.
Drug: Epoetin Beta
Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 g/dL versus baseline.
Also known as: Recormon
Hemoglobin levels at 16 weeks
Time frame: 16 Weeks
Serum Iron, Ferritin and Transferrin Levels
Time frame: 16 Weeks
Time to Global Response
Time frame: Up to 4 months
Percentage of Participants with a Positive Response
Time frame: Weeks 4 and 8
Quality of Life in Relation to Grade of Anemia
Time frame: Up to 4 months
Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument
Time frame: Up to 4 months
Tolerability - Incidence of Adverse Events
Time frame: Up to 16 Weeks of treatment period
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche