ATGAM General Investigation

NCT06039020 · tracked via the Priya Life Science Japan tracker

Sponsor

Pfizer

Phase

Observational

Started

2024-02-21

Last updated

2025-11-18

Condition(s) studied

Aplastic Anemia

Investigational drug(s) / intervention(s)

Anti-human thymocyte immunoglobulin, equine

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.

Study 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.

Eligibility

Sex

ALL

Min age

0 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with moderate to severe aplastic anemia who receive ATGAM Exclusion Criteria: * No exclusion criteria is set out in this study.

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Pfizer	Tokyo	Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06039020 on ClinicalTrials.gov ↗ ← All trials in Japan