AnemiaNCT01809314

An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy

An observational study of Anemia, run by Hoffmann-La Roche at 42 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon) in participants with symptomatic anemia and cancer receiving chemotherapy. Participants receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months. 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
How many people: 1,167 participants
Where: 42 sitesHungary
Study dates: Mar 2008to Oct 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Participants with symptomatic anemia due to malignancies will be included.

Who may be able to join

Adults greater than or equal to (≥) 18 years of age
Participants with solid tumors or lymphoproliferative disease
Participants receiving chemotherapy
Participants for whom erythropoietin is indicated for pre-study Hb level and observed anemic symptoms: Hb less than (<) 11 g/dL or 6.83 millimoles per liter (mmol/L)
ECOG performance status of 0, 1, or 2

Who cannot join

Resistant hypertension
Acute chronic bleeding within 3 months prior to study
Iron deficiency that is unmanageable prior to study
Hypersensitivity to the active substance or any of the excipients of the product
Pregnant or breastfeeding women
Epoetin treatment within 6 months prior to study

Trial locations and contacts

42 sites in 1 country.

City, postcode or hospital

42 sites in 1 country

Hungary42 sites

Study site
Budapest, 1031
Study site
Budapest, 1076
Study site
Budapest, 1082
Study site
Budapest, 1083
Study site
Budapest, 1085
Study site
Budapest, 1088
Study site
Budapest, 1097
Study site
Budapest, 1106
Study site
Budapest, 1122
Study site
Budapest, 1125
Study site
Budapest, 1145
Study site
Budapest, 1529
Study site
Debrecen, 4012
Study site
Debrecen, 4032
Study site
Debrecen, H-4031
Study site
Deszk, 6772
Study site
Dunaújváros, 2400
Study site
Eger, 3300
Study site
Farkasgyepű, 8582
Study site
Győr, 9024
Study site
Gyula, 5700
Study site
Kaposvár, 7400
Study site
Kecskemét, 6000
Study site
Miskolc, 3501
Study site
Miskolc, 3529
Study site
Mosdós, 7257
Study site
Nyíregyháza, 4400
Study site
Pécs, 7623
Study site
Pécs, 7624
Study site
Pécs, 7635
Study site
Salgótarján, 3100
Study site
Szeged, 6720
Study site
Székesfehérvár, 8000
Study site
Székesfehérvár, 8001
Study site
Szekszárd, 7100
Study site
Szolnok, 5004
Study site
Szolnok, 5007
Study site
Szombathely, 9700
Study site
Tatabánya, 2800
Study site
Törökbálint, 2045
Study site
Veszprém, 8200
Study site
Zalaegerszeg, 8900

Other trials in Hungary

About this study

Official title: Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy

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
Treatment will be given according to standard of care and the Summary of Product Characteristics during the study.

Study groups in NCT01809314
Study group	Role	What they receive
NeoRecormon in Symptomatic Anemia		Participants with symptomatic anemia who are receiving epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics will be observed for 4 months. Treatment must be selected at the discretion of the prescriber prior to enrollment and will not be chosen by the Sponsor in this non-interventional study. Receives: Drug: Epoetin beta

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)
The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).
Measured: Baseline, Month 4

Secondary outcomes (2)

Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as "Baseline 0, EOT 2". Transition to a lower performance status indicates improved/increased independence.
Measured: Baseline, Month 4
Percentage of Participants Who Required Blood Transfusions During the Study
The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit.
Measured: Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Oct 2009

First posted12 Mar 2013 (estimated)
Study startMar 2008
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01809314
Sponsor's protocol ID: ML21420
Status last verified: Jun 2016
First submitted: 8 Mar 2013
Last updated: 19 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
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A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
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Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
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RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy
ClinicalTrials.gov ID: NCT01809314
Acronym / sponsor ID: ML21420
Conditions: Anemia
Study type: Observational
Recruitment status: Completed
Enrolment: 1,167 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 12 Mar 2013 (estimated)
Results: Posted 19 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
NeoRecormon in Symptomatic Anemia	–	Drug: Epoetin betaParticipants with symptomatic anemia who are receiving epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics will be observed for 4 months. Treatment must be selected at the discretion of the prescriber prior to enrollment and will not be chosen by the Sponsor in this non-interventional study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with symptomatic anemia due to malignancies will be included.

Key inclusion criteria (5 listed)

Adults greater than or equal to (≥) 18 years of age
Participants with solid tumors or lymphoproliferative disease
Participants receiving chemotherapy
Participants for whom erythropoietin is indicated for pre-study Hb level and observed anemic symptoms: Hb less than (<) 11 g/dL or 6.83 millimoles per liter (mmol/L)
ECOG performance status of 0, 1, or 2

Key exclusion criteria (6 listed)

Resistant hypertension
Acute chronic bleeding within 3 months prior to study
Iron deficiency that is unmanageable prior to study
Hypersensitivity to the active substance or any of the excipients of the product
Pregnant or breastfeeding women

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: NeoRecormonTreatment will be given according to standard of care and the Summary of Product Characteristics during the study.	Drug	NeoRecormon in Symptomatic Anemia

Primary outcome

Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)
Time frame: Baseline, Month 4
The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).

2 secondary outcomes

Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Time frame: Baseline, Month 4
Percentage of Participants Who Required Blood Transfusions During the Study
Time frame: Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4

Results and safety

Results posted to the registry on 19 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NeoRecormon in Symptomatic Anemia	1,167	422

Primary outcome: Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)

Time frame: Baseline, Month 4. Mean (95% Confidence Interval). Unit: g/L

Measure	NeoRecormon in Symptomatic Anemia n = 280
Value	14.58 (12.684 to 16.478)

NeoRecormon in Symptomatic Anemia: p <0.0001, Wilcoxon signed-rank test

Population analysed: All Participants Enrolled; only those who provided data at all study visits were included in the analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to Month 4. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NeoRecormon in Symptomatic Anemia	7 of 1,167 (0.6%)	6 of 1,167 (0.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

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 director

Hoffmann-La Roche

42 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, run by Hoffmann-La Roche at 42 sites in Hungary.

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 5 inclusion and 6 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Hungary. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) (time frame: Baseline, Month 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01809314.

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 19 Aug 2016.