ATGAM General Investigation

NCT06039020 | Active Not Recruiting FDA Drug

• 1 other identifier: B5411004
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Aplastic Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse drug reactions (ADRs)

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

Study Arms (1)

Anti-human thymocyte immunoglobulin, equine

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

Drug: Anti-human thymocyte immunoglobulin, equine

Interventions

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.

Anti-human thymocyte immunoglobulin, equine

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with moderate to severe aplastic anemia who receive ATGAM

You may qualify if:

• Patients with moderate to severe aplastic anemia who receive ATGAM

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: February 21, 2024
• Primary Completion (Estimated): January 22, 2027
• Study Completion (Estimated): January 22, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)