ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05888870

Enrollment

Registered

2023-06-05

Start date

2023-11-22

Completion date

2026-12-01

Last updated

2025-02-24

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

Conditions

Hemophilia A With Inhibitor

Brief 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.

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.

Interventions

DRUGSCT800 and Daratumumab

SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times

DRUGSCT800

SCT800 50IU/kg TIW alone

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Moderate or severe hemophilia A; 2. Aged 14-66 years old; 3. Inhibitor positive at 2 consecutive visits; 4. Inhibitor titer \> 10 BU at the screening visit.

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

Measure	Time frame	Description
success rate of ITI success rate of ITI success rate of ITI success rate of ITI	12 months	Inhibitor titre \<0.6 BU⁄mL
Success rate and partial success rate of ITI after 3-month treatment	3 months	Inhibitor titre \<0.6 BU⁄mL

Secondary

Measure	Time frame	Description
ITI success time	12 months	time to successful tolerance

Countries

China

Contacts

Primary ContactWei Liu

liuwei1@ihcams.ac.cn+8613820261971

Backup ContactLei Zhang

zhanglei1@ihcams.ac.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026