Randomised Study Comparing Different Dosages of Rabbit AT... | NCT01844635

Studies
Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA

NCT01844635

Sponsor

Nagoya University

Status

Unknown status

Last Update Posted

Apr 1, 2016Estimated

Enrollment

320Estimated

Phase

Phase 3

Conditions

Acquired Aplastic Anemia.

Interventions

Thymoglobulin

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

Mar 2016

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

May 2012

Primary Completion Date

May 2016Estimated

Completion Date

Not provided

First Submitted Date

Apr 29, 2013

First Submission Date that Met QC Criteria

Apr 29, 2013

First Posted Date

May 1, 2013Estimated

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

Mar 31, 2016

Last Update Posted Date

Apr 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.

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

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2.5 mg/kg/day of Thymoglobulin for 5 days	Experimental	2.5 mg/kg/day of Thymoglobulin for 5 days	Drug: Thymoglobulin
3.5 mg/kg/day of Thymoglobulin for 5 days	Active Comparator	3.5 mg/kg/day of Thymoglobulin for 5 days	Drug: Thymoglobulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thymoglobulin	Drug		2.5 mg/kg/day of Thymoglobulin for 5 days 3.5 mg/kg/day of Thymoglobulin for 5 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.		day 180 after the start of IST

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acquired aplastic anemia
Age: younger than 70 years old
Severity: SAA, VSAA.
Interval between diagnosis and registration <6 months.
Written informed consent from the caretakers and/or whenever possible consent from the patient.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

69 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seiji Kojima, MD., PhD.	Contact	+81-52-744-2294		kojimas@med.nagoya-u.ac.jp
Hideki Muramatsu, MD., PhD.	Contact	+81-52-744^2294		hideki-muramatsu@med.nagoya-u.ac.jp

Overall Officials

Name	Affiliation	Role
Seiji Kojima, MD., PhD.	Department of Pediatrics, Nagoya University Graduate School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Nagoya University Graduate School of Medicine	Recruiting	Nagoya	Aichi-ken	466-8550	Japan

Intervention Browse Module

MeSH Terms

ID	Term
C512542	thymoglobulin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided