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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT02608060 |
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Date of registration:
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16/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B
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Scientific title:
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Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels of Patients With Anemia Related to Non- Hodgkin Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma, Treated With Erythropoietin B (Recormon) Using Pre-filled Syringe With 30000 IU, as Well as to Quantify the Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02608060 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Venezuela
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult participants with a diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic
leukemia or multiple myeloma
- Anemia at Screening Visit
Exclusion Criteria:
- Transfusion of red blood cells within 2 months of study drug
- Treatment-resistant hypertension
- Acute or chronic bleeding (requiring therapy) within 3 months of study drug
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Intervention(s)
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Drug: Epoetin Beta
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Primary Outcome(s)
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Hemoglobin levels at 16 weeks
[Time Frame: 16 Weeks]
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Secondary Outcome(s)
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Serum Iron, Ferritin and Transferrin Levels
[Time Frame: 16 Weeks]
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Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument
[Time Frame: Up to 4 months]
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Tolerability - Incidence of Adverse Events
[Time Frame: Up to 16 Weeks of treatment period]
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Quality of Life in Relation to Grade of Anemia
[Time Frame: Up to 4 months]
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Time to Global Response
[Time Frame: Up to 4 months]
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Percentage of Participants with a Positive Response
[Time Frame: Weeks 4 and 8]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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