Basiliximab for the Treatment of Acute Graft-versus-host... | NCT00563108

Studies
Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

NCT00563108

Sponsor

Hospital Authority, Hong Kong

Status

Unknown status

Last Update Posted

Jul 7, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Graft vs Host Disease
Hematopoietic Stem Cell Transplantation

Interventions

Basiliximab
Placebo

Countries

China

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

ID	Type	Description	Link
HARECCTR0500037

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Nov 21, 2007

First Submission Date that Met QC Criteria

Nov 21, 2007

First Posted Date

Nov 26, 2007Estimated

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

Jul 6, 2010

Last Update Posted Date

Jul 7, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hospital Authority, Hong KongOTHER_GOV

Collaborators

Name	Class
Novartis Pharmaceuticals	INDUSTRY
The Hong Kong Blood Cancer Foundation	OTHER

Description Module

Brief Summary

Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity and mortality. Steroids remains first line therapy for acute GVHD but there is currently no consensus on second line therapy for those in whom steroids have been ineffective. Basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and treatment of rejection after renal transplantation and its role in acute GVHD prophylaxis and treatment has been described favourably. This is a randomized control trial to investigate its efficacy and safety in the management of acute GVHD post allogeneic stem cell transplantation (SCT).

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resolution of GVHD by Day 12		12 days

Secondary Outcomes

Measure	Description	Time Frame
Duration and grading of acute GVHD		100 days
Total dose of steroid and immunosuppresant		100 days
Mortality, GVHD-related and all cause

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Grade II to IV acute GVHD after SCT

Exclusion Criteria:

Known allergy to basilixmab

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Winnie WW Cheung, Dr	Contact	(852) 2855 3111		cheungww@hotmail.com

Overall Officials

Name	Affiliation	Role
Lawrence SY Ma, Dr	Department of Medicine/ Haematology and Oncology, Queen Mary Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Hong Kong	Recruiting	Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D006086	Graft vs Host Disease

Ancestor Terms

ID	Term
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077552	Basiliximab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Basiliximab	Drug
Placebo	Drug