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OpenTrials
Active, Not Recruiting

NCT Number: NCT06039020

ATGAM General Investigation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aplastic Anemia Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate to severe aplastic anemia who receive ATGAM

Exclusion criteria

  • No exclusion criteria is set out in this study.

Treatment and study plan

Anti-human thymocyte immunoglobulin, equine

Drug

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.

Primary outcomes

  1. Number of participants with adverse drug reactions (ADRs)

    Time frame: 24 weeks (6 months) from the start of administration (Day 1)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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