ATGAM General Investigation

ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06039020

Enrollment

Registered

2023-09-15

Start date

2024-02-21

Completion date

2027-01-22

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic Anemia

Keywords

ATGAM;, Anti-human thymocyte immunoglobulin, equine;, Aplastic anemia;

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.

Interventions

DRUGAnti-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with moderate to severe aplastic anemia who receive ATGAM

Exclusion criteria

* No

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse drug reactions (ADRs)	24 weeks (6 months) from the start of administration (Day 1)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026