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Trial record 1 of 1 for:    NCT02140736
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Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology (ORHEO)

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ClinicalTrials.gov Identifier: NCT02140736
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer

Brief Summary:
The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

Condition or disease Intervention/treatment
Chemotherapy-induced Symptomatic Anemia Solid Tumors Malignant Hemopathies Lymphomas Myelomas Drug: Epoetin biosimilar

Detailed Description:
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin to correct haemoglobin levels.

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Study Type : Observational
Actual Enrollment : 2333 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study
Study Start Date : September 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 1, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort Intervention/treatment
Patients with chemo-induced symptomatic anemia Drug: Epoetin biosimilar



Primary Outcome Measures :
  1. Change and corrected Hemoglobin levels [ Time Frame: 6 months ]
    Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.


Secondary Outcome Measures :
  1. Observe evolution of the biological indicators [ Time Frame: 6 months ]
    Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation

  2. Study the profiles of treated patients [ Time Frame: 6 months ]
  3. Assess the reasons for the prescriber's treatment regimens [ Time Frame: 6 months ]
  4. Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics [ Time Frame: 6 months ]
  5. Observation of the safety profiles of the Product (Epoetin Alfa) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
Criteria

Inclusion Criteria:

  • Patients of more than 18 years of age
  • Patients presenting with anemia following chemotherapy
  • Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following 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

Exclusion Criteria:

  • Patients are not receiving chemotherapy
  • Patients already included in an epoetin zeta trial
  • Patients presenting with a contraindication to epoetin zeta
  • Patients presenting with hypersensitivity to the active principle or any of the excipients
  • Patient with erythroblastopenia or acquired pure red cell aplasia (APRCA)
  • Patient with uncontrollable arterial hypertension
  • Patients who cannot receive adequate prophylaxis by antithrombotic agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140736


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Sponsors and Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT02140736     History of Changes
Other Study ID Numbers: 1_09.04.2009
09.214 ( Other Identifier: CCTIRS )
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: July 2015

Keywords provided by Hospira, now a wholly owned subsidiary of Pfizer:
Chemotherapy-induced anemia
Epoetin biosimilar

Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics