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

NCT ID: NCT01844635

Last Updated: 2016-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Brief Summary

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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

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Conditions

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Acquired Aplastic Anemia.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2.5 mg/kg/day of Thymoglobulin for 5 days

2.5 mg/kg/day of Thymoglobulin for 5 days

Group Type EXPERIMENTAL

Thymoglobulin

Intervention Type DRUG

3.5 mg/kg/day of Thymoglobulin for 5 days

3.5 mg/kg/day of Thymoglobulin for 5 days

Group Type ACTIVE_COMPARATOR

Thymoglobulin

Intervention Type DRUG

Interventions

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Thymoglobulin

Intervention Type DRUG

Eligibility Criteria

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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

\-
Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagoya University

OTHER

Sponsor Role lead

Responsible Party

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Hideki Muramatsu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seiji Kojima, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Nagoya University Graduate School of Medicine

Locations

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Department of Pediatrics, Nagoya University Graduate School of Medicine

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Seiji Kojima, MD., PhD.

Role: CONTACT

+81-52-744-2294

Hideki Muramatsu, MD., PhD.

Role: CONTACT

+81-52-744^2294

Facility Contacts

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Seiji Kojima, MD., PhD.

Role: primary

+81-52-744-2294

Hideki Muramatsu, MD., PhD.

Role: backup

+81-52-744-2294

Other Identifiers

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APBMT AAWG-01

Identifier Type: -

Identifier Source: org_study_id

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