AnemiaPhase 4NCT02624141
A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy
A Phase 4 study testing Epoetin Beta in people with Anemia, run by Hoffmann-La Roche at 2 sites in Venezuela.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Epoetin Beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesVenezuela
- Study dates
- Apr 2006to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with a non-myeloid malignancy
- Anemia
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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
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.
- Conditions
- Anemia
- Being tested
- Epoetin Beta
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin BetaDrug
Also called Recormon
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.
| Study group | Role | What they receive |
|---|---|---|
| Epoetin Beta 30000 IU | Experimental | Dosage 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. Receives: Drug: Epoetin Beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Levels at 16 Weeks
Measured: 16 Weeks
Secondary outcomes (8)
Serum Iron Levels
Measured: 16 Weeks
Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument
Measured: Up to 4 months
Tolerability - Incidence of Adverse Events
Measured: Up to 4 months
Serum Transferrin Levels
Measured: 16 Weeks
Percentage of Participants With A Positive Response
Measured: 16 Weeks
Time To Global Response
Measured: Up to 4 months
Quality of Life In Relation to Anemia Grade
Measured: Up to 4 months
Serum Ferritin Levels
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startApr 2006
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: The study was terminated due to low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624141
- Sponsor's protocol ID
- ML18054
- Status last verified
- Nov 2016
- First submitted
- 2 Dec 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02624141
- Acronym / sponsor ID
- ML18054
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to low recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epoetin Beta 30000 IU | Experimental | Drug: Epoetin BetaDosage 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with a non-myeloid malignancy
- Anemia
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin BetaAlso: RecormonDosage 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. | Drug | Epoetin Beta 30000 IU |
Primary outcome
Hemoglobin Levels at 16 Weeks
Time frame: 16 Weeks
8 secondary outcomes
Serum Iron Levels
Time frame: 16 Weeks
Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument
Time frame: Up to 4 months
Tolerability - Incidence of Adverse Events
Time frame: Up to 4 months
Serum Transferrin Levels
Time frame: 16 Weeks
Percentage of Participants With A Positive Response
Time frame: 16 Weeks
Time To Global Response
Time frame: Up to 4 months
Quality of Life In Relation to Anemia Grade
Time frame: Up to 4 months
Serum Ferritin Levels
Time frame: 16 Weeks
Results and safety
The study was stopped early (reason given: The study was terminated due to low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Hoffmann-La Roche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin Beta in people with Anemia, run by Hoffmann-La Roche at 2 sites in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin Levels at 16 Weeks (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.