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Completed

NCT Number: NCT01716559

An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy

This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, >/=18 years of age
  • Presence of solid-tumor or non-myeloid malignancy
  • Patients receiving chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • Patients require NeoRecormon

Exclusion criteria

  • Hypersensitivity to the drug
  • Uncontrolled hypertension
  • Female patients if pregnant and/or lactating

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8

    Time frame: Baseline to Week 8

    Therapeutic response was defined as an increase of greater than or equal to (>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of >= 1 g/dL in Hb level at Week 8 as compared to baseline.

Secondary outcomes

  1. Mean Change From Baseline in Hemoglobin Level up to Week 16

    Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16

    The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.

  2. Percentage of Red Blood Cell Transfusion-free Participants

    Time frame: Up to Week 16

    Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.

  3. Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy

    Time frame: Up to Week 16

    Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (>) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as "1" denotes an effect on the response of treatment with or without iron replacement therapy. Response value as "0" denotes no effect on the response of treatment with or without iron replacement therapy.

  4. Number of Participants With Adverse Events and Serious Adverse Events

    Time frame: Up to Week 16

    An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Multicenter, Observational Study to Evaluate NeoRecormon Treatment in Anemic Patients Suffering From Non-myeloid Malignancy Receiving Chemotherapy

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 30, 2012
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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