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

NCT05888870 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-02-24

No results posted yet for this study

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.

Conditions

  • Hemophilia A With Inhibitor

Interventions

DRUG

SCT800 and Daratumumab

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

DRUG

SCT800

SCT800 50IU/kg TIW alone

Sponsors & Collaborators

  • Sinocelltech Ltd.

    collaborator INDUSTRY

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Lei Zhang · Chinese Academy of Medical Science and Blood Disease Hospital

  • Renchi Yang · Chinese Academy of Medical Science and Blood Disease Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05888870 on ClinicalTrials.gov