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

Primary Purpose

Anemia

Status

Terminated

Phase

Phase 4

Locations

Venezuela

Study Type

Interventional

Intervention

Epoetin Beta

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epoetin Beta 30000 IU

Arm Description

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.

Outcomes

Primary Outcome Measures

Hemoglobin Levels at 16 Weeks

Secondary Outcome Measures

Serum Iron Levels

Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument

Tolerability - Incidence of Adverse Events

Serum Transferrin Levels

Percentage of Participants With A Positive Response

Time To Global Response

Quality of Life In Relation to Anemia Grade

Serum Ferritin Levels

Full Information

NCT ID

NCT02624141

First Posted

December 2, 2015

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02624141

Brief Title

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

Official Title

Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels, of Patients With Anemia Reklated to Malignant Tumors, Treated With Erythropoietin B (Recormon) Using the Pre-Filled Syringe With 30,000 IU, as Well as to Quantify Teh Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated due to low recruitment

Study Start Date

April 2006 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epoetin Beta 30000 IU

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Epoetin Beta

Other Intervention Name(s)

Recormon

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hemoglobin Levels at 16 Weeks

Time Frame

16 Weeks

Secondary Outcome Measure Information:

Title

Serum Iron Levels

Time Frame

16 Weeks

Title

Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument

Time Frame

Up to 4 months

Title

Tolerability - Incidence of Adverse Events

Time Frame

Up to 4 months

Title

Serum Transferrin Levels

Time Frame

16 Weeks

Title

Percentage of Participants With A Positive Response

Time Frame

16 Weeks

Title

Time To Global Response

Time Frame

Up to 4 months

Title

Quality of Life In Relation to Anemia Grade

Time Frame

Up to 4 months

Title

Serum Ferritin Levels

Time Frame

16 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Chair

Facility Information:

City

Caracas

ZIP/Postal Code

1060

Country

Venezuela

City

Valencia

ZIP/Postal Code

2001

Country

Venezuela

12. IPD Sharing Statement

Learn more about this trial

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

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