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NCT Number: NCT07461116

Adverse Effects of 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

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Key information

Conditions

Aplastic Anaemia Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Regenerative Medicine Center and Red Blood Cell Disorders Center

Tianjin, China

Location status: Recruiting

Location contact

Weiwang Li, PhD

CONTACT

[email protected]

15332132036

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ATG/ALG

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Weiwang Li, PhD

CONTACT

[email protected]

15332132036

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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