Study Stopped
The study was terminated due to low recruitment
A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy
Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels, of Patients With Anemia Reklated to Malignant Tumors, Treated With Erythropoietin B (Recormon) Using the Pre-Filled Syringe With 30,000 IU, as Well as to Quantify Teh Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment
1 other identifier
interventional
10
1 country
2
Brief Summary
This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units \[IU\]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2006
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 2, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedNovember 2, 2016
November 1, 2016
3.7 years
December 2, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin Levels at 16 Weeks
16 Weeks
Secondary Outcomes (8)
Serum Iron Levels
16 Weeks
Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument
Up to 4 months
Tolerability - Incidence of Adverse Events
Up to 4 months
Serum Transferrin Levels
16 Weeks
Percentage of Participants With A Positive Response
16 Weeks
- +3 more secondary outcomes
Study Arms (1)
Epoetin Beta 30000 IU
EXPERIMENTALDosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks.
Interventions
Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.
Eligibility Criteria
You may qualify if:
- Adult patients with a non-myeloid malignancy
- Anemia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Caracas, 1060, Venezuela
Unknown Facility
Valencia, 2001, Venezuela
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2015
First Posted
December 8, 2015
Study Start
April 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
November 2, 2016
Record last verified: 2016-11