A Study of the Quality of Life and Treatment Response to Once Weekly Epoetin Beta (Recormon) Treatment in Anemic Participants With Solid and Lymphoid Malignancies

NCT ID: NCT00776425

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-11-30

Brief Summary

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This 2 arm study will investigate Quality of Life response in anemic participants with solid and lymphoid malignancies, who are receiving concomitant chemotherapy. Participants with solid and lymphoid malignancies will receive epoetin beta at a dose of 150 international units per kilogram (IU/kg) three times weekly. Participants with lymphoid malignancies will receive epoetin beta 30000 IU once weekly.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epoetin Beta 150 IU/kg

Participants with solid and lymphoid malignancies will receive subcutaneous or intravenous epoetin beta at a dose of 150 IU per kg of body weight thrice weekly.

Group Type EXPERIMENTAL

Epoetin beta

Intervention Type DRUG

Epoetin beta subcutaneously or intravenously at a dose of 150 IU per kg of body weight thrice weekly or 30000 IU once weekly.

Epoetin Beta 30000 IU

Participants with lymphoid malignancies will receive subcutaneous or intravenous epoetin beta at a dose of 30000 IU once weekly.

Group Type EXPERIMENTAL

Epoetin beta

Intervention Type DRUG

Epoetin beta subcutaneously or intravenously at a dose of 150 IU per kg of body weight thrice weekly or 30000 IU once weekly.

Interventions

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Epoetin beta

Epoetin beta subcutaneously or intravenously at a dose of 150 IU per kg of body weight thrice weekly or 30000 IU once weekly.

Intervention Type DRUG

Other Intervention Names

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Recormon

Eligibility Criteria

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Inclusion Criteria

* Anemia and prescribed treatment with epoetin beta
* Confirmed diagnosis of a solid or lymphoid hematologic malignancy
* Receiving or scheduled to receive chemotherapy
* Life expectancy of greater than or equal to (\>=6) months

Exclusion Criteria

* Anemia after bleeding, hemolytic anemia, megaloblastic anemia, anemia in chronic kidney failure, lever and endocrinology diseases
* Contraindications to epoetin beta
* Administration of epoetin beta during chemotherapy (e.g., on the third day after chemotherapy cycle start)
* Bleeding within one month before and/or during study
* Severe infection within one month before and/or during study
* Inability of participant to fill the questionnaires
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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Arkhangelsk, , Russia

Site Status

Barnaul, , Russia

Site Status

Belgorod, , Russia

Site Status

Ivanovo, , Russia

Site Status

Kazan', , Russia

Site Status

Kostroma, , Russia

Site Status

Lipetsk, , Russia

Site Status

Moscow, , Russia

Site Status

Moscow, , Russia

Site Status

Novosibirsk, , Russia

Site Status

Petrozavodsk, , Russia

Site Status

Ryazan, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Salekhard, , Russia

Site Status

Sashi, , Russia

Site Status

Surgut, , Russia

Site Status

Tver', , Russia

Site Status

Tyumen, , Russia

Site Status

Ufa, , Russia

Site Status

Yaroslavl, , Russia

Site Status

Countries

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Russia

Other Identifiers

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ML20197

Identifier Type: -

Identifier Source: org_study_id

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