Clinical trial · Observational
An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy
Multicenter, Observational Study to Evaluate NeoRecormon Treatment in Anemic Patients Suffering From Non-myeloid Malignancy Receiving Chemotherapy
NCT01716559CI-TRIAL-00023554completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort
Primary outcomes (1)
- measure
- Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8
- timeFrame
- Baseline to Week 8
- description
- Therapeutic response was defined as an increase of greater than or equal to (\>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of \>= 1 g/dL in Hb level at Week 8 as compared to baseline.
Secondary outcomes (4)
- measure
- Mean Change From Baseline in Hemoglobin Level up to Week 16
- timeFrame
- Baseline, Week 4, Week 8, Week 12, and Week 16
- description
- The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/=18 years of age * Presence of solid-tumor or non-myeloid malignancy * Patients receiving chemotherapy * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 * Patients require NeoRecormon Exclusion Criteria: * Hypersensitivity to the drug * Uncontrolled hypertension * Female patients if pregnant and/or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.