Acquired HemophiliaPhase 4AHA2023NCT05849740
An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A
A Phase 4 study testing Daratumumab and corticosteroid treatment in people with Acquired Hemophilia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To evaluate the time of response, sustained remission rate and relapse rate of CD38 monoclonal antibody (Daratumumab) combined corticosteroid in the treatment of AHA. To evaluate the safety of CD38 monoclonal antibody in the treatment of AHA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Hemophilia
- What is being tested?
- Daratumumab and corticosteroid treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2023to 31 Oct 2027
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all enrollment criteria before they can be enrolled:
- Diagnosed as AHA; Women are postmenopausal women or women of childbearing age with strict contraception; Patients with good compliance
Who cannot join
- Patients with any of the following items cannot be enrolled in this study:
- Congenital hemophilia with inhibitor; Pregnant and lactating women; Who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody (Ⅰ + Ⅱ) and syphilis antibody; Patients with poor compliance; Who cannot use contraception during the trial; Researchers believe that it is not appropriate for patients to participate in any other condition of this trial; Four weeks before entering the group, the patients received immunosuppressive therapy and the inhibitor showed a progressive decreasing trend (the change was less than 50%).
- Acquired von Willebrand disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lei Zhang contact
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin
Shuo Chen, chenshuo@ihcams.ac.cn
Lijun Liu, gcp@ihcams.ac.cn
About this study
Official title: A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)
To evaluate the time of response, sustained remission rate and relapse rate of CD38 monoclonal antibody (Daratumumab) combined corticosteroid in the treatment of AHA. To evaluate the safety of CD38 monoclonal antibody in the treatment of AHA.
Read the detailed description
This is a prospective ,single-arm, multi-center controlled pilot trial of CD38 (Daratumumab) monoclonal antibody combined corticosteroid in the treatment of AHA patients.
Patients will receive Daratumumab and corticosteroid treatment in this trial.
- Conditions
- Acquired Hemophilia
- Being tested
- Daratumumab and corticosteroid treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab and corticosteroid treatmentDrug
Also called Intervention arm
Daratumumab and corticosteroid treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Daratumumab and corticosteroid treatment Receives: Drug: Daratumumab and corticosteroid treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total response rate to treatment (OR) Total response rate to treatment
The proportion of patients achieving OR including CR and PR
Measured: During 8 weeks
Secondary outcomes (6)
the proportion of patients with complete remission (CR)
The proportion of patients achieving CR , which is defined as titer FVIII inhibitor lower than 0.6 Bethesda unit, factor VIII level≥ 50%
Measured: During 8 weeks
the proportion of patients with partial remission rate (PR)
The proportion of patients achieving PR, which is defined as titer FVIII inhibitor higher than 0.6 Bethesda unit and factor VIII level≥ 50%, and no bleedings will be evaluated.
Measured: During 8 weeks
time to CR
The time for patients to reach complete remission
Measured: During 8 weeks
The proportion of patients remaining in CR during 24 weeks
The proportion of patients who reached CR and remain in CR during 24 weeks of follow -up time
Measured: During 24 weeks
The proportion of patients relapse after reaching CR during 24 weeks
The proportion of patients who reached CR and relapse during 24 weeks of follow -up time
Measured: During 24 weeks
Safety outcome
Adverse events will be collected
Measured: From start of the treatment until the end of 24 weeks in the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start22 May 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired HemophiliaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, Principal investigator, Chinese Academy of Medical Science and Blood Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849740
- Sponsor's protocol ID
- IIT2023013
- Acronym
- AHA2023
- Status last verified
- Jan 2025
- First submitted
- 18 Apr 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be requested from the corresponding authors from 12 months to 36 months after study completion
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm Exploratory Study of CD38 (Daratumumab) Monoclonal Antibody (Daratumumab) Combined Corticosteroid in the Treatment of Acquired Hemophilia A (AHA)
- ClinicalTrials.gov ID
- NCT05849740
- Acronym / sponsor ID
- AHA2023 / IIT2023013
- Conditions
- Acquired Hemophilia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 May 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.
To evaluate the time of response, sustained remission rate and relapse rate of CD38 monoclonal antibody (Daratumumab) combined corticosteroid in the treatment of AHA. To evaluate the safety of CD38 monoclonal antibody in the treatment of AHA.
Detailed description
This is a prospective ,single-arm, multi-center controlled pilot trial of CD38 (Daratumumab) monoclonal antibody combined corticosteroid in the treatment of AHA patients.
Patients will receive Daratumumab and corticosteroid treatment in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Daratumumab and corticosteroid treatmentDaratumumab and corticosteroid treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must meet all enrollment criteria before they can be enrolled:
- Diagnosed as AHA; Women are postmenopausal women or women of childbearing age with strict contraception; Patients with good compliance
Key exclusion criteria (3 listed)
- Patients with any of the following items cannot be enrolled in this study:
- Congenital hemophilia with inhibitor; Pregnant and lactating women; Who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody (Ⅰ + Ⅱ) and syphilis antibody; Patients with poor compliance; Who cannot use contraception during the trial; Researchers believe that it is not appropriate for patients to participate in any other condition of this trial; Four weeks before entering the group, the patients received immunosuppressive therapy and the inhibitor showed a progressive decreasing trend (the change was less than 50%).
- Acquired von Willebrand disease
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 |
|---|---|---|
| Daratumumab and corticosteroid treatmentAlso: Intervention armDaratumumab and corticosteroid treatment | Drug | Treatment arm |
Primary outcome
Total response rate to treatment (OR) Total response rate to treatment
Time frame: During 8 weeks
The proportion of patients achieving OR including CR and PR
6 secondary outcomes
the proportion of patients with complete remission (CR)
Time frame: During 8 weeks
the proportion of patients with partial remission rate (PR)
Time frame: During 8 weeks
time to CR
Time frame: During 8 weeks
The proportion of patients remaining in CR during 24 weeks
Time frame: During 24 weeks
The proportion of patients relapse after reaching CR during 24 weeks
Time frame: During 24 weeks
Safety outcome
Time frame: From start of the treatment until the end of 24 weeks in the follow-up period
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 5 Aug 2025.
- Individual participant dataSharing planned: Yes. Data can be requested from the corresponding authors from 12 months to 36 months after study completion
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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.
Lei Zhang contact
Lei Zhang principal investigator
Chinese Academy of Medical Science and Blood Disease Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daratumumab and corticosteroid treatment in people with Acquired Hemophilia, 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 3 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 5 Aug 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wei Liu (+8613820261971, liuwei1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total response rate to treatment (OR) Total response rate to treatment (time frame: During 8 weeks). 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 5 Aug 2025.