Hemophilia A With InhibitorPhase 4NCT05888870
ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
A Phase 4 study testing SCT800 and Daratumumab and SCT800 in people with Hemophilia A With Inhibitor, 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 with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Hemophilia A With Inhibitor
- What is being tested?
- SCT800 and Daratumumab and SCT800
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2023to 1 Dec 2026
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate or severe hemophilia A;
- Aged 14-66 years old;
- Inhibitor positive at 2 consecutive visits;
- Inhibitor titer > 10 BU at the screening visit.
Who cannot join
- The patient has contraindications to drug ingredients or hamster protein allergy;
- Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);
- Failed systemic ITI treatment in history;
- Poor patients compliance;
- The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.
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
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin
Shuo Chen, chenshuo@ihcams.ac.cn
L Liu, gcp@ihcams.ac.cn
About this study
Official title: The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Non-randomized Controlled Trial
To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.
Read the detailed description
This is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingnon- SCT800 combined with Daratumumab or SCT800 alone in hemophilia A adolescents and adults with high titer inhibitors. Patients will receive Daratumumab combined with SCT800 or SCT800 alone.
- Conditions
- Hemophilia A With Inhibitor
- Being tested
- SCT800 and Daratumumab, SCT800
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT800 and DaratumumabDrug
Also called Immune tolerance induction combine anti-CD38
SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
SCT800Drug
Also called Immune tolerance induction only
SCT800 50IU/kg TIW alone
| Study group | Role | What they receive |
|---|---|---|
| SCT800 combined with Daratumumab | Experimental | ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) and treated with Daratumumab 8mg/kg 4-8 times. Other immunosuppressants could be added after 3 months. Receives: Drug: SCT800 and Daratumumab |
| SCT800 alone | Active comparator | ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months. Receives: Drug: SCT800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of ITI success rate of ITI success rate of ITI success rate of ITI
Inhibitor titre <0.6 BU⁄mL
Measured: 12 months
Success rate and partial success rate of ITI after 3-month treatment
Inhibitor titre <0.6 BU⁄mL
Measured: 3 months
Secondary outcomes (1)
ITI success time
time to successful tolerance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start22 Nov 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia A With InhibitorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sinocelltech Ltd.
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, Principal investigator, Chinese Academy of Medical Science and Blood Disease HospitalRenchi Yang, Principal investigator, Chinese Academy of Medical Science and Blood Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888870
- Sponsor's protocol ID
- IIT2022035
- Status last verified
- Jan 2025
- First submitted
- 24 May 2023
- Last updated
- 24 Feb 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05888870
- Acronym / sponsor ID
- IIT2022035
- Conditions
- Hemophilia A With Inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Sinocelltech Ltd.
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Jun 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 with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.
Detailed description
This is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingnon- SCT800 combined with Daratumumab or SCT800 alone in hemophilia A adolescents and adults with high titer inhibitors. Patients will receive Daratumumab combined with SCT800 or SCT800 alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCT800 combined with Daratumumab | Experimental | Drug: SCT800 and DaratumumabITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) and treated with Daratumumab 8mg/kg 4-8 times. Other immunosuppressants could be added after 3 months. |
| SCT800 alone | Active comparator | Drug: SCT800ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate or severe hemophilia A;
- Aged 14-66 years old;
- Inhibitor positive at 2 consecutive visits;
- Inhibitor titer > 10 BU at the screening visit.
Key exclusion criteria (5 listed)
- The patient has contraindications to drug ingredients or hamster protein allergy;
- Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);
- Failed systemic ITI treatment in history;
- Poor patients compliance;
- The investigator believes that there are any other reasons that make the patient unsuitable to participate 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 |
|---|---|---|
| SCT800 and DaratumumabAlso: Immune tolerance induction combine anti-CD38SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times | Drug | SCT800 combined with Daratumumab |
| SCT800Also: Immune tolerance induction onlySCT800 50IU/kg TIW alone | Drug | SCT800 alone |
Primary outcome
success rate of ITI success rate of ITI success rate of ITI success rate of ITI
Time frame: 12 months
Inhibitor titre <0.6 BU⁄mL
Success rate and partial success rate of ITI after 3-month treatment
Time frame: 3 months
Inhibitor titre <0.6 BU⁄mL
1 secondary outcome
ITI success time
Time frame: 12 months
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 24 Feb 2025.
- Individual participant dataSharing planned: Yes. Data can be requested from the corresponding authors from 12 months to 36 months after study completion
Related trials for Hemophilia A With Inhibitor
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A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A
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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
Renchi Yang 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 SCT800 and Daratumumab and SCT800 in people with Hemophilia A With Inhibitor, 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 4 inclusion and 5 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 24 Feb 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?
success rate of ITI success rate of ITI success rate of ITI success rate of ITI (time frame: 12 months). The study lists 2 primary outcomes in all. 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 24 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.