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ATGAM General Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06039020
Recruitment Status : Active, not recruiting
First Posted : September 15, 2023
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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
Aplastic Anemia Drug: Anti-human thymocyte immunoglobulin, equine

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION
Actual Study Start Date : February 21, 2024
Estimated Primary Completion Date : February 13, 2026
Estimated Study Completion Date : February 13, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Number of participants with adverse drug reactions (ADRs) [ Time Frame: 24 weeks (6 months) from the start of administration (Day 1) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with moderate to severe aplastic anemia who receive ATGAM
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039020


Locations
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Japan
Pfizer
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT06039020    
Other Study ID Numbers: B5411004
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Keywords provided by Pfizer:
ATGAM;
Anti-human thymocyte immunoglobulin, equine;
Aplastic anemia;
Additional relevant MeSH terms:
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Anemia, Aplastic
Anemia
Hematologic Diseases
Bone Marrow Failure Disorders
Bone Marrow Diseases
 Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunologic Factors
Physiological Effects of Drugs