ATGAM General Investigation

Active, not recruiting

• Conditions: Aplastic Anemia
• Interventions: Drug: Anti-human thymocyte immunoglobulin, equine

• Registration Number: NCT06039020
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Start: 2024-02-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-01-22
• Study Completion: 2027-01-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patients with moderate to severe aplastic anemia who receive ATGAM

Exclusion Criteria

• No exclusion criteria is set out in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anti-human thymocyte immunoglobulin, equine	Anti-human thymocyte immunoglobulin, equine	Patients with moderate to severe aplastic anemia who receive ATGAM (Anti-human thymocyte immunoglobulin, equine)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan