ATGAM General Investigation

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06039020
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 29.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aplastic Anemia	Drug: Anti-human thymocyte immunoglobulin, equine

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ATGAM Intravenous Infusion 250mg General Investigation
• Anticipated Study Start Date: Sep 28, 2023
• Anticipated Primary Completion Date: Mar 12, 2026
• Anticipated Study Completion Date: Mar 12, 2026

Arms and Interventions

Arm	Intervention/Treatment
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; 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with moderate to severe aplastic anemia who receive ATGAM

Exclusion Criteria:

• No exclusion criteria is set out in this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT06039020
• Other Study ID Numbers: B5411004
• First Posted: Sep 15, 2023
• Last Update Posted: Sep 15, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: ATGAM;; Anti-human thymocyte immunoglobulin, equine;; Aplastic anemia
• Additional relevant MeSH terms: Anemia, Aplastic; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies

Study Results

No Results Posted as of Sep 15, 2023