Trials / Active Not Recruiting
Active Not RecruitingNCT06039020
ATGAM General Investigation
ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 0 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2024-02-21
- Primary completion
- 2027-01-22
- Completion
- 2027-01-22
- First posted
- 2023-09-15
- Last updated
- 2025-11-18
Locations
1 site across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06039020. Inclusion in this directory is not an endorsement.