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

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ClinicalTrials.gov Identifier: NCT01844635
Recruitment Status : Unknown
Verified March 2016 by Hideki Muramatsu, Nagoya University.
Recruitment status was:  Recruiting
First Posted : May 1, 2013
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hideki Muramatsu, Nagoya University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acquired Aplastic Anemia. Drug: Thymoglobulin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia
Study Start Date : May 2012
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 2.5 mg/kg/day of Thymoglobulin for 5 days
2.5 mg/kg/day of Thymoglobulin for 5 days
 Drug: Thymoglobulin
Active Comparator: 3.5 mg/kg/day of Thymoglobulin for 5 days
3.5 mg/kg/day of Thymoglobulin for 5 days
 Drug: Thymoglobulin


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844635


Contacts
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Contact: Seiji Kojima, MD., PhD. +81-52-744-2294 kojimas@med.nagoya-u.ac.jp
Contact: Hideki Muramatsu, MD., PhD. +81-52-744^2294 hideki-muramatsu@med.nagoya-u.ac.jp

Locations
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Japan
Department of Pediatrics, Nagoya University Graduate School of Medicine Recruiting
Nagoya, Aichi, Japan, 466-8550
Contact: Seiji Kojima, MD., PhD.    +81-52-744-2294    kojimas@med.nagoya-u.ac.jp   
Contact: Hideki Muramatsu, MD., PhD.    +81-52-744-2294    hideki-muramatsu@med.nagoya-u.ac.jp   
Principal Investigator: Seiji Kojima, MD., PhD.         
Sponsors and Collaborators
Nagoya University
Investigators
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Principal Investigator: Seiji Kojima, MD., PhD. Department of Pediatrics, Nagoya University Graduate School of Medicine
More Information
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Responsible Party: Hideki Muramatsu, Assistant Professor, Nagoya University
ClinicalTrials.gov Identifier: NCT01844635    
Other Study ID Numbers: APBMT AAWG-01
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Failure Disorders
Bone Marrow Diseases
 Thymoglobulin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents