Aplastic AnemiaNCT06039020
ATGAM General Investigation
An observational study of Aplastic Anemia, run by Pfizer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Aplastic Anemia
- What is being tested?
- Anti-human thymocyte immunoglobulin, equine
- Type of treatment
- Injection or infusion
- How many people
- 1 participants
- Where
- 1 siteJapan
- Study dates
- 21 Feb 2024to 22 Jan 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with moderate to severe aplastic anemia who receive ATGAM
Who may be able to join
- Patients with moderate to severe aplastic anemia who receive ATGAM
Who cannot join
- No exclusion criteria is set out in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION
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.
- Conditions
- Aplastic Anemia
- Being tested
- Anti-human thymocyte immunoglobulin, equine
- Keywords
- ATGAM;, Anti-human thymocyte immunoglobulin, equine;, Aplastic anemia;
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-human thymocyte immunoglobulin, equineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Anti-human thymocyte immunoglobulin, equine | Patients with moderate to severe aplastic anemia who receive ATGAM (Anti-human thymocyte immunoglobulin, equine) Receives: Drug: Anti-human thymocyte immunoglobulin, equine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse drug reactions (ADRs)
Measured: 24 weeks (6 months) from the start of administration (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start21 Feb 2024
- Primary completion22 Jan 2027 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039020
- Sponsor's protocol ID
- B5411004
- Status last verified
- Oct 2025
- First submitted
- 8 Sep 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION
- ClinicalTrials.gov ID
- NCT06039020
- Acronym / sponsor ID
- B5411004
- Conditions
- Aplastic Anemia
- Keywords
- ATGAM;, Anti-human thymocyte immunoglobulin, equine;, Aplastic anemia;
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 22 Jan 2027 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 15 Sep 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-human thymocyte immunoglobulin, equine | – | Drug: Anti-human thymocyte immunoglobulin, equinePatients with moderate to severe aplastic anemia who receive ATGAM (Anti-human thymocyte immunoglobulin, equine) |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with moderate to severe aplastic anemia who receive ATGAM
Key inclusion criteria (1 listed)
- Patients with moderate to severe aplastic anemia who receive ATGAM
Key exclusion criteria (1 listed)
- No exclusion criteria is set out in this study.
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 |
|---|---|---|
| Anti-human thymocyte immunoglobulin, equineUsually, 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. | Drug | Anti-human thymocyte immunoglobulin, equine |
Primary outcome
Number of participants with adverse drug reactions (ADRs)
Time frame: 24 weeks (6 months) from the start of administration (Day 1)
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 18 Nov 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
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 Anemia, run by Pfizer at 1 site in Japan.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. 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 Japan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse drug reactions (ADRs) (time frame: 24 weeks (6 months) from the start of administration (Day 1)). 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 18 Nov 2025.