Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia
1 other identifier
interventional
320
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 29, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedApril 1, 2016
March 1, 2016
4 years
April 29, 2013
March 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
2.5 mg/kg/day of Thymoglobulin for 5 days
EXPERIMENTAL2.5 mg/kg/day of Thymoglobulin for 5 days
3.5 mg/kg/day of Thymoglobulin for 5 days
ACTIVE COMPARATOR3.5 mg/kg/day of Thymoglobulin for 5 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics, Nagoya University Graduate School of Medicine
Nagoya, Aichi-ken, 466-8550, Japan
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Seiji Kojima, MD., PhD.
Department of Pediatrics, Nagoya University Graduate School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 29, 2013
First Posted
May 1, 2013
Study Start
May 1, 2012
Primary Completion
May 1, 2016
Last Updated
April 1, 2016
Record last verified: 2016-03