Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
Sponsor
Nagoya University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01844635
Collaborator
(none)
320
1
2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated 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 1, 2012
Anticipated Primary Completion Date
:
May 1, 2016
Arms and Interventions
| 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
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. [day 180 after the start of IST]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pediatrics, Nagoya University Graduate School of Medicine | Nagoya | Aichi | Japan | 466-8550 |
Sponsors and Collaborators
- Nagoya University
Investigators
- Principal Investigator: Seiji Kojima, MD., PhD., Department of Pediatrics, Nagoya University Graduate School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hideki Muramatsu,
Assistant Professor,
Nagoya University
ClinicalTrials.gov Identifier:
NCT01844635
Other Study ID Numbers:
- APBMT AAWG-01
First Posted:
May 1, 2013
Last Update Posted:
Apr 1, 2016
Last Verified:
Mar 1, 2016