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

March 31, 2016 updated by: Hideki Muramatsu, Nagoya University

A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 466-8550
        • Recruiting
        • Department of Pediatrics, Nagoya University Graduate School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seiji Kojima, MD., PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 69 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 2.5 mg/kg/day of Thymoglobulin for 5 days
Drug: Thymoglobulin
ACTIVE_COMPARATOR: 3.5 mg/kg/day of Thymoglobulin for 5 days
Drug: Thymoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: day 180 after the start of IST
day 180 after the start of IST

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagoya University

Investigators

  • Principal Investigator: Seiji Kojima, MD., PhD., Department of Pediatrics, Nagoya University Graduate School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (ESTIMATE)

May 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APBMT AAWG-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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