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ATGAM General Investigation
Sponsor: Pfizer
Summary
The objective of this study is to confirm the safety of ATGAM in patients with moderate to severe aplastic anemia under the actual use in Japan. The registration criteria is patients with moderate to severe aplastic anemia who receive ATGAM. The observation period is 24 weeks (6 months) from the start of administration (Day 1). However, in cases where treatment has been completed or discontinued less than 24 weeks after the start of administration, observation is continued until completion (discontinuation) of treatment.
Official title: ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION
Key Details
Gender
All
Age Range
0 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1
Start Date
2024-02-21
Completion Date
2027-01-22
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
Anti-human thymocyte immunoglobulin, equine
Usually, 40 mg of anti-human thymocyte immunoglobulin, equine per kilogram of body weight should be slowly administered by intravenous drip infusion once daily. The duration of treatment should be 4 days.
Locations (1)
Pfizer
Tokyo, Japan