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.
Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.
Pfizer Inc (PFE) is the sponsoring company for this trial. BiotechSign currently grades this company F (33/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.