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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 randomized controlled trial

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 randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067033
Enrollment
Unknown
Registered
2022-12-23
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemophilia A

Interventions

experimental group:SCT800 combined with Daratumumab
control group:SCT800 alone

Sponsors

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. moderate or severe hemophilia A 2. 14-66 years old 3. inhibitor positive at 2 consecutive visits 4. inhibitor titer > 10 BU at the screening visit

Exclusion criteria

Exclusion criteria: 1. The patient has contraindications to drug ingredients or hamster protein allergy 2. Suffering from other immune diseases or Using immunosuppressant IS to treat another disease (s) 3. failed systemic ITI treatment in history 4. Poor patients compliance 5. The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
success rate of ITI;Success rate and partial sucess rate of ITI after 3-month treatment;—

Secondary

MeasureTime frame
partial sucess rate of ITI;median time to ITI success or partial success;ABR;EQ-5D-5L;absence from work or school;therapy cost;safety;—

Countries

China

Contacts

Public ContactRenchi Yang

Hematology Hospital of Chinese Academy of Medical Sciences

rcyang65@163.com+86 22 23909999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026