Back to resultsRandomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
Primary Purpose
Acquired Aplastic Anemia.
Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Thymoglobulin
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Aplastic Anemia.
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:
-
Sites / Locations
- Department of Pediatrics, Nagoya University Graduate School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
2.5 mg/kg/day of Thymoglobulin for 5 days
3.5 mg/kg/day of Thymoglobulin for 5 days
Arm Description
2.5 mg/kg/day of Thymoglobulin for 5 days
3.5 mg/kg/day of Thymoglobulin for 5 days
Outcomes
Primary Outcome Measures
Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01844635
Brief Title
Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
Official Title
A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Aplastic Anemia.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2.5 mg/kg/day of Thymoglobulin for 5 days
Arm Type
Experimental
Arm Description
2.5 mg/kg/day of Thymoglobulin for 5 days
Arm Title
3.5 mg/kg/day of Thymoglobulin for 5 days
Arm Type
Active Comparator
Arm Description
3.5 mg/kg/day of Thymoglobulin for 5 days
Intervention Type
Drug
Intervention Name(s)
Thymoglobulin
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seiji Kojima, MD., PhD.
Phone
+81-52-744-2294
Email
kojimas@med.nagoya-u.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Hideki Muramatsu, MD., PhD.
Phone
+81-52-744^2294
Email
hideki-muramatsu@med.nagoya-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seiji Kojima, MD., PhD.
Organizational Affiliation
Department of Pediatrics, Nagoya University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Nagoya University Graduate School of Medicine
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seiji Kojima, MD., PhD.
Phone
+81-52-744-2294
Email
kojimas@med.nagoya-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Hideki Muramatsu, MD., PhD.
Phone
+81-52-744-2294
Email
hideki-muramatsu@med.nagoya-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Seiji Kojima, MD., PhD.
12. IPD Sharing Statement
Learn more about this trial
Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
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