AnemiaPhase 4NCT02564094
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
A Phase 4 study testing Epoetin beta in people with Anemia, run by Hoffmann-La Roche at 9 sites in Bulgaria.
Trial summary
This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 9 sitesBulgaria
- Study dates
- Feb 2005to Jun 2006
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Bulgaria9 sites
Study site
Plovdiv, 4000
Study site
Plovdiv, 4004
Study site
Sofia, 1527
Study site
Sofia, 1756
Study site
Sofia, 1757
Study site
Sofia, 1784
Study site
Stara Zagora, 8000
Study site
Varna, 9002
Study site
Varna, 9010
About this study
Official title: Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly
This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 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 NeoRecormon
Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Epoetin beta | Experimental | Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks. Receives: Drug: Epoetin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate according to hemoglobin level
Measured: At Week 4
Transfusion requirement rate
Measured: From Weeks 5 to 12
Predictive value of reticulocyte increase
Measured: At Week 2
Secondary outcomes (1)
Incidence of adverse events (AEs)
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startFeb 2005
- Primary completionJun 2006
- Study completionJun 2006
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
- 54 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
- NCT02564094
- Sponsor's protocol ID
- ML18043
- Status last verified
- Nov 2016
- First submitted
- 28 Sep 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
- Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly
- ClinicalTrials.gov ID
- NCT02564094
- Acronym / sponsor ID
- ML18043
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 30 Sep 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 evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 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 | Experimental | Drug: Epoetin betaParticipants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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: NeoRecormonParticipants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks. | Drug | Epoetin beta |
Primary outcome
Response rate according to hemoglobin level
Time frame: At Week 4
Transfusion requirement rate
Time frame: From Weeks 5 to 12
Predictive value of reticulocyte increase
Time frame: At Week 2
1 secondary outcome
Incidence of adverse events (AEs)
Time frame: Up to approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
9 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 9 sites in Bulgaria.
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 3 inclusion and 4 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: finished, 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 9 sites in Bulgaria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate according to hemoglobin level (time frame: At Week 4). The study lists 3 primary outcomes in all. 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.