Adverse Effects of ATG/ALG Therapy in Aplastic Anemia

NCT07461116 | Recruiting

• 1 other identifier: AA-ATG/ALG-20260108
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aplastic Anaemia

Keywords

Aplastic Anaemia; ATG/ALG

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with serum sickness and its severity

  Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity

  Within 4 weeks after ATG/ALG infusion

Secondary Outcomes (2)

• Percentage of patients with liver and kidney function damage and 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

  During ATG/ALG infusion(typically from d1 to d6)

Study Arms (1)

Patients with aplastic anemia undergoing ATG or ALG treatment

Drug: ATG/ALG

Interventions

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.

Patients with aplastic anemia undergoing ATG or ALG treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Aplastic anemia patients treated with ATG/ALG

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Regenerative Medicine Center and Red Blood Cell Disorders Center

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases

Central Study Contacts

Weiwang Li, PhD

CONTACT

15332132036; liweiwang@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Red Blood Cell Diseases Center & Director of the Regenerative Medicine Clinic

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 10, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)