|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
14 November 2016 |
|
Main ID: |
NCT02564094 |
|
Date of registration:
|
28/09/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
|
|
Scientific title:
|
Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly |
|
Date of first enrolment:
|
February 2005 |
|
Target sample size:
|
54 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02564094 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Bulgaria
| | | | | | | |
|
Contacts
|
|
Name:
|
Clinical Trials |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hoffmann-La Roche |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adults at least 18 years of age
- Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic
leukemia (CLL), breast cancer, lung cancer, or ovarian cancer
- Anemia with low erythropoeitin (EPO) levels
Exclusion Criteria:
- Poorly controlled hypertension
- Relevant acute or chronic bleeding requiring therapy within 3 months before study
drug
- Treatment with EPO within the last 6 weeks
- Pregnant or breastfeeding females
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Anemia
|
|
Intervention(s)
|
|
Drug: Epoetin beta
|
|
Primary Outcome(s)
|
|
Response rate according to hemoglobin level
[Time Frame: At Week 4]
|
|
Predictive value of reticulocyte increase
[Time Frame: At Week 2]
|
|
Transfusion requirement rate
[Time Frame: From Weeks 5 to 12]
|
|
Secondary Outcome(s)
|
|
Incidence of adverse events (AEs)
[Time Frame: Up to approximately 6 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|