Clinical Study of Epoetin Beta to Chemotherapy-Induced An... | NCT00628043

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

NCT00628043

Sponsor

Chugai Pharmaceutical

Status

Completed

Last Update Posted

Sep 18, 2009Estimated

Enrollment

160Estimated

Phase

Phase 3

Conditions

Anemia

Interventions

epoetin beta
placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

May 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Feb 24, 2008

First Submission Date that Met QC Criteria

Mar 3, 2008

First Posted Date

Mar 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2009

Last Update Posted Date

Sep 18, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EPOCH	Experimental		Drug: epoetin beta
placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
epoetin beta	Drug	Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks	EPOCH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Hb		16 weeks
Change in FACT- total Fatigue Subscale score (FSS)		16 weeks
Requirement for RBC transfusion

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoshito Suzuki	Chugai Pharmaceutical	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chugoku/Shikoku Region		Chugoku/Shikoku			Japan
Chubu Region

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia
D009369	Neoplasms

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C103998	epoetin beta

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided