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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716559
• Other study ID #: ML25362
• Status: Completed
• Phase: N/A
• First received: October 11, 2012
• Last updated: August 16, 2016
• Start date: August 2010
• Est. completion date: March 2012

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at 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.	Baseline to Week 8	No
Secondary	Mean Change From Baseline in Hemoglobin Level up to Week 16	The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.	Baseline, Week 4, Week 8, Week 12, and Week 16	No
Secondary	Percentage of Red Blood Cell Transfusion-free Participants	Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.	Up to Week 16	No
Secondary	Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy	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.	Up to Week 16	No
Secondary	Number of Participants With Adverse Events and Serious Adverse Events	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.	Up to Week 16	No