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A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy

NCT ID: NCT02624141

Last Updated: 2016-11-02

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-12-31

Brief Summary

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This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units \[IU\]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epoetin Beta 30000 IU

Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks.

Group Type EXPERIMENTAL

Epoetin Beta

Intervention Type DRUG

Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.

Interventions

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Epoetin Beta

Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.

Intervention Type DRUG

Other Intervention Names

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Recormon

Eligibility Criteria

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Inclusion Criteria

* Adult patients with a non-myeloid malignancy
* Anemia

Exclusion Criteria

* Transfusion of red blood cells within 2 months of study drug
* Treatment-resistant hypertension
* Acute or chronic bleeding (requiring therapy) within 3 months of study drug
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_CHAIR

Hoffmann-La Roche

Locations

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Caracas, , Venezuela

Site Status

Valencia, , Venezuela

Site Status

Countries

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Venezuela

Other Identifiers

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ML18054

Identifier Type: -

Identifier Source: org_study_id