ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Pfizer
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse drug reactions (ADRs)
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with moderate to severe aplastic anemia who receive ATGAM
Exclusion Criteria
- •No exclusion criteria is set out in this study.
Arms & Interventions
Anti-human thymocyte immunoglobulin, equine
Patients with moderate to severe aplastic anemia who receive ATGAM (Anti-human thymocyte immunoglobulin, equine)
Intervention: Anti-human thymocyte immunoglobulin, equine (Drug)
Outcomes
Primary Outcomes
Number of participants with adverse drug reactions (ADRs)
Time Frame: 24 weeks (6 months) from the start of administration (Day 1)
Secondary Outcomes
No secondary outcomes reported