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NCT06039020 Clinical Trial

ATGAM General Investigation

Aplastic Anemia Clinical Trial

Official title:
ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06039020
Other study ID # B5411004
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 21, 2024
Est. completion date February 13, 2026

Study information
Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date February 13, 2026
Est. primary completion date February 13, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Japan Pfizer Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse drug reactions (ADRs) 24 weeks (6 months) from the start of administration (Day 1)
See also
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Completed NCT00513175 - Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia N/A
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Completed NCT00065260 - Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia Phase 2
Recruiting NCT02007811 - Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination Phase 1/Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
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