search
Back to results

Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
epoetin beta
placebo
Sponsored by
Chugai Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Cancer, patients, with, chemotherapy, induced, anemia

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lung cancer or gynecologic cancer patients
  • Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration
  • 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL
  • 20 - 79 years old
  • Performance status: 0 - 2
  • No iron deficiency anemia

Exclusion Criteria:

  • Red blood cell transfusion within 4 weeks before treatment
  • Erythropoietin therapy within 8 weeks before treatment

Sites / Locations

  • Chubu Region
  • Chugoku/Shikoku Region
  • Hokkaido/Tohoku Region
  • Kanto/Koshinetsu Region
  • Kinki/Hokuriku Region
  • Kyushu Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EPOCH

placebo

Arm Description

Outcomes

Primary Outcome Measures

The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL

Secondary Outcome Measures

Change in Hb
Change in FACT- total Fatigue Subscale score (FSS)
Requirement for RBC transfusion

Full Information

First Posted
February 24, 2008
Last Updated
September 17, 2009
Sponsor
Chugai Pharmaceutical
search

1. Study Identification

Unique Protocol Identification Number
NCT00628043
Brief Title
Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients
Official Title
A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chugai Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Cancer, patients, with, chemotherapy, induced, anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EPOCH
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
epoetin beta
Intervention Description
Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subcutaneous administration of placebo once-weekly for 12 weeks
Primary Outcome Measure Information:
Title
The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in Hb
Time Frame
16 weeks
Title
Change in FACT- total Fatigue Subscale score (FSS)
Time Frame
16 weeks
Title
Requirement for RBC transfusion
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lung cancer or gynecologic cancer patients Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL 20 - 79 years old Performance status: 0 - 2 No iron deficiency anemia Exclusion Criteria: Red blood cell transfusion within 4 weeks before treatment Erythropoietin therapy within 8 weeks before treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshito Suzuki
Organizational Affiliation
Chugai Pharmaceutical
Official's Role
Study Chair
Facility Information:
Facility Name
Chubu Region
City
Chubu
Country
Japan
Facility Name
Chugoku/Shikoku Region
City
Chugoku/Shikoku
Country
Japan
Facility Name
Hokkaido/Tohoku Region
City
Hokkaido/Tohoku
Country
Japan
Facility Name
Kanto/Koshinetsu Region
City
Kanto/Koshinetsu
Country
Japan
Facility Name
Kinki/Hokuriku Region
City
Kinki/Hokuriku
Country
Japan
Facility Name
Kyushu Region
City
Kyushu
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

We'll reach out to this number within 24 hrs