Aplastic AnaemiaNCT07461116
Adverse Effects of ATG/ALG Therapy in Aplastic Anemia
An observational study of Aplastic Anaemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aplastic Anaemia
- What is being tested?
- ATG/ALG
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Aplastic anemia patients treated with ATG/ALG
Who may be able to join
- Meet the diagnostic criteria for aplastic anemia (Camitta criteria);
- Receiving ATG/ALG immunosuppressive therapy for the first time;
Who cannot join
- Previously received hematopoietic stem cell transplantation;
- Aplastic anemia patients receiving ATG/ALG as part of transplant conditioning regimen;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Regenerative Medicine Center and Red Blood Cell Disorders Center
Tianjin
Weiwang Li, PhD, 15332132036, liweiwang@ihcams.ac.cn
About this study
Official title: 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
- Conditions
- Aplastic Anaemia
- Being tested
- ATG/ALG
- Keywords
- Aplastic Anaemia, ATG/ALG
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG/ALGDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with aplastic anemia undergoing ATG or ALG treatment | Not described Receives: Drug: ATG/ALG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with serum sickness and its severity
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity
Measured: Within 4 weeks after ATG/ALG infusion
Secondary outcomes (2)
Percentage of patients with liver and kidney function damage and its severity
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity
Measured: 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
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity
Measured: During ATG/ALG infusion(typically from d1 to d6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start23 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnaemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Shi, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461116
- Sponsor's protocol ID
- AA-ATG/ALG-20260108
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Dynamics and Grading Criteria Construction of Adverse Reactions to ATG/ALG Therapy in Aplastic Anemia
- ClinicalTrials.gov ID
- NCT07461116
- Acronym / sponsor ID
- AA-ATG/ALG-20260108
- Conditions
- Aplastic Anaemia
- Keywords
- Aplastic Anaemia, ATG/ALG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with aplastic anemia undergoing ATG or ALG treatment | – | Drug: ATG/ALG |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Aplastic anemia patients treated with ATG/ALG
Key inclusion criteria (2 listed)
- Meet the diagnostic criteria for aplastic anemia (Camitta criteria);
- Receiving ATG/ALG immunosuppressive therapy for the first time;
Key exclusion criteria (2 listed)
- Previously received hematopoietic stem cell transplantation;
- Aplastic anemia patients receiving ATG/ALG as part of transplant conditioning regimen;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG/ALGParticipants 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. | Drug | Patients with aplastic anemia undergoing ATG or ALG treatment |
Primary outcome
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
2 secondary outcomes
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
Percentage of patients with infusion reaction and its severity
Time frame: During ATG/ALG infusion(typically from d1 to d6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aplastic Anaemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiwang Li, PhD (15332132036, liweiwang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with serum sickness and its severity (time frame: Within 4 weeks after ATG/ALG infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.