Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology
1 other identifier
observational
291
1 country
39
Brief Summary
The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Typical duration for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMarch 20, 2017
July 1, 2015
2 years
June 7, 2012
March 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change and corrected Hemoglobin levels
Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
6 months
Secondary Outcomes (5)
Observation of blood value development
6 months
Evaluation of the profiles of treated patients
6 months
Evaluation of prescriber's therapy plan
6 months
Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics
6 months
Observation of the tolerability profile of Epoetin Zeta
6 months
Eligibility Criteria
Patients with chemotherapy-induced symptomatic anaemia. Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
You may qualify if:
- Patients age ≥18 years .
- Patients present with chemotherapy-induced symptomatic anaemia.
- Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
- The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
- Patients eligible for epoetin alfa biosimilar treatment.
You may not qualify if:
- Patients are not receiving chemotherapy.
- Patients already included in an epoetin zeta study.
- Patients presenting with the contraindications to epoetin zeta.
- Patients presenting with the hypersensitivity to the active substance or any of the excipients.
- The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA).
- Patients with uncontrolled hypertension.
- Patients who cannot receive adequate prophylaxis by antithrombotic agents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Alzey, 55232, Germany
Unknown Facility
Bad Säckigen, 79713, Germany
Unknown Facility
Berlin, 10367, Germany
Unknown Facility
Berlin, 12627, Germany
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Berlin, 13593, Germany
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Bonn, 53123, Germany
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Bonn, 53177, Germany
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Borken, 46325, Germany
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Brandenburg, 14770, Germany
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Chemnitz, 09113, Germany
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Cottbus, 03046, Germany
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Essen, 45239, Germany
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Frankenthal, 67227, Germany
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Garbsen, 30827, Germany
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Halberstadt, 38820, Germany
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Hanover, 30171, Germany
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Herne, 44623, Germany
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Holzkirchen, 83607, Germany
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Krefeld, 47798, Germany
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München, 80638, Germany
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München, 81479, Germany
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Münster, 48149, Germany
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Neuss, 41462, Germany
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Nuremberg, 90409, Germany
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Oberhausen, 46045, Germany
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Oberhausen, 46145, Germany
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Olpe, 57462, Germany
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Oranienburg, 16515, Germany
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Paderborn, 33098, Germany
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Parchim, 19370, Germany
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Plauen, 08523, Germany
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Remscheid, 42859, Germany
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Rodgau, 63110, Germany
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Rötha, 04571, Germany
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Schönebeck, 39218, Germany
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Soest, 59494, Germany
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Stralsund, 18435, Germany
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Stuttgart, 70190, Germany
Unknown Facility
Velbert, 42551, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 22, 2012
Study Start
December 1, 2010
Primary Completion
December 1, 2012
Study Completion
July 1, 2013
Last Updated
March 20, 2017
Record last verified: 2015-07