Adverse Effects of ATG/ALG Therapy in Aplastic Anemia

March 4, 2026 updated by: Jun Shi, Institute of Hematology & Blood Diseases Hospital, China

A Study on the Dynamics and Grading Criteria Construction of Adverse Reactions to ATG/ALG Therapy in Aplastic Anemia

This prospective, single-center, observational cohort study aims to systematically observe and describe the clinical characteristics of adverse reactions in patients with aplastic anemia undergoing ATG (Anti-Thymocyte Globulin) /ALG (Anti-Lymphocyte Globulin) treatment, providing a data foundation for the development of relevant management strategies. This study plans to enroll 200 aplastic anemia patients undergoing ATG/ALG treatment

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Regenerative Medicine Center and Red Blood Cell Disorders Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Aplastic anemia patients treated with ATG/ALG

Description

Inclusion Criteria:

  • Meet the diagnostic criteria for aplastic anemia (Camitta criteria);
  • Receiving ATG/ALG immunosuppressive therapy for the first time;

Exclusion Criteria:

  • Previously received hematopoietic stem cell transplantation;
  • Aplastic anemia patients receiving ATG/ALG as part of transplant conditioning regimen;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with aplastic anemia undergoing ATG or ALG treatment
Drug: ATG/ALG
Participants will receive ATG/ALG according to standard dosing protocols as per clinical guidelines. During treatment, we will monitor and document any adverse reactions, including their type, severity, duration, and any necessary interventions or changes in treatment plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with serum sickness and its severity
Time Frame: Within 4 weeks after ATG/ALG infusion
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity
Within 4 weeks after ATG/ALG infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with liver and kidney function damage and its severity
Time Frame: During ATG/ALG infusion (typically from d1 to d6) and within 4 weeks after ATG/ALG infusion
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity
During ATG/ALG infusion (typically from d1 to d6) and within 4 weeks after ATG/ALG infusion
Percentage of patients with infusion reaction and its severity
Time Frame: During ATG/ALG infusion(typically from d1 to d6)
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity
During ATG/ALG infusion(typically from d1 to d6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA-ATG/ALG-20260108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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