Biosimilar RetacritTM (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology
This study is ongoing, but not recruiting participants.
Sponsor:
Hospira, Inc.
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01626547
First received: June 7, 2012
Last updated: January 9, 2013
Last verified: January 2013
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Purpose
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anaemia and being treated with RetacritTM to correct haemoglobin levels.
| Condition |
|---|
|
Chemotherapy-induced Symptomatic Anaemia Solid Tumors Malignant Lymphomas Multiple Myeloma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Biosimilar RetacritTM (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology |
Resource links provided by NLM:
Further study details as provided by Hospira, Inc.:
Primary Outcome Measures:
- Change and corrected Hemoglobin levels [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
Secondary Outcome Measures:
- Observation of blood value development [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
Biospecimen Retention: Samples With DNA
Concentrations of haemoglobin, thrombocytes, leukocytes, neutrophil and CRP are represented across time (v1, 2 and 3)
| Estimated Enrollment: | 240 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- Patients are 18 years of age or over.
- 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
- Patients can be recruited at any time (from the first to the final chemotherapy cycle.)
- Patients would be suited for a course of treatment with RetacritTM (epoetin zeta)
Exclusion Criteria:
- Patients are not undergoing chemotherapy.
- Patients have already taken part in a RetacritTM study.
- The patients have contraindications to Retacrit(TM)
- Patients have hypersensitivity to the active principle or to one of the excipients.
- The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA)
- Uncontrollable hypertension
- An adequate prophylaxis against thrombosis is not practicable
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626547
Locations
| Germany | |
| "Medizinisches Versorgungszentrum | |
| Berlin, Germany, 10407 | |
| MediOnko-Institut GRR | |
| Berlin, Germany, 10367 | |
| Onkoplan GmbH/ Onkologische Schwerpunktpraxis | |
| Berlin, Germany, 13055 | |
| Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie | |
| Berlin, Germany, 12627 | |
| "Facharzt für Innere Medizin | |
| Borken, Germany, 46325 | |
| Frauenarzt | |
| Brandenburg, Germany, 14770 | |
| Poliklinik GmbH Chemnitz | |
| Chemnitz, Germany, 09113 | |
| Fachärztin für Innere Medizin / Hämatologie / Onkologie | |
| Cottbus, Germany, 03046 | |
| "Facharzt für Innere Medizin/ | |
| Dresden, Germany, 1307 | |
| "Facharzt für Innere Medizin Hamatologie und Internistische Onkologie | |
| Eisenach, Germany, 99817 | |
| Internist / Hämatologe / Intern. Onkologie | |
| Frankenthal, Germany, 67227 | |
| Internist - Hämatologe - Onkologe | |
| Garbsen, Germany, 30827 | |
| Hämatologie und Onkologie | |
| Gosiar, Germany, 38642 | |
| Medizinisches Studien- und Dokumentationszentrum | |
| Groitzsch, Germany, 04539 | |
| FA für Innere Medizin - Hämatologie - Internistische Onkologie | |
| Halberstadt, Germany, 38820 | |
| MediProjekt Ges. f. Medizinstatistik und Projektentwicklung | |
| Hannover, Germany, 30171 | |
| Internist - Hämatologe - Onkologe | |
| Hannover, Germany, 30625 | |
| ODZ-Petersen GmbH | |
| Heidenheim, Germany, 89518 | |
| DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG | |
| Herne, Germany, 44632 | |
| "Medizinisches Versorgungszentrum MP Saaletal GmbH | |
| Jena, Germany, 07743 | |
| OnkoMed GbR | |
| Krefeld, Germany, 47805 | |
| Facharzle fur Innere Medizin - Hamatologie u. Intemistische Onkologie | |
| Munchen, Germany, 81479 | |
| Facharzte fur Innere Medizin - Hamatologie u. Intermistische Onkologie - Bluttransfusionswesen | |
| Munchen, Germany, 80638 | |
| Gemeinschaftspraxis für Hämatologie und Onkologie | |
| Munster, Germany, 48149 | |
| Tumorzentrum Niederrhein GmbH | |
| Neuss, Germany, 41462 | |
| Facharzt für Frauenheilkunde und Geburtshilfe | |
| Oberhausen, Germany, 46045 | |
| Überörtliche Gemeinschaftspraxis | |
| Oberhausen, Germany, 46145 | |
| Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis | |
| Olpe, Germany, 57462 | |
| Fachärztin für Frauenheilkunde und Geburtshilfe | |
| Oranienburg, Germany, 16515 | |
| Medizinisches Versorgungszentrum GbR | |
| Paradiese, Germany, 59494 | |
| FA f. Innere Medizin, Onkologie und Endokrinologie | |
| Parchim, Germany, 19370 | |
| Facharzt für Innere Medizin - Medikamentöse Tumortheraphie | |
| Remscheid, Germany, 42859 | |
| Frauenarzt | |
| Rodgau, Germany, 63110 | |
| "FA f. Frauenheilkunde und Geburtshilfe SP Gynakologische Onkologie | |
| Stralsund, Germany, 18435 | |
| Praxis fur Hamatologie und Internistische Onkologie | |
| Velbert, Germany, 42551 | |
| Facharzt für Innere Medizin Hamatologie und Onkologie | |
| Verden, Germany, 27283 | |
| Onkologische Schwerpunktpraxis Hamatologie und Onkologie | |
| VS-Villingen, Germany, 78050 | |
Sponsors and Collaborators
Hospira, Inc.
More Information
No publications provided
| Responsible Party: | Hospira, Inc. |
| ClinicalTrials.gov Identifier: | NCT01626547 History of Changes |
| Other Study ID Numbers: | ORHEO |
| Study First Received: | June 7, 2012 |
| Last Updated: | January 9, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Hospira, Inc.:
|
symptomatic anameia |
Additional relevant MeSH terms:
|
Anemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Hematologic Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 23, 2013