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

NCT ID: NCT01716559

Last Updated: 2016-08-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Kaposvár, , Hungary

Site Status

Szolnok, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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ML25362

Identifier Type: -

Identifier Source: org_study_id

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