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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14-65
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this 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.

Eligibility criteria

Qualifiers

Moderate or severe hemophilia A;

Aged 14-66 years old;

Inhibitor positive at 2 consecutive visits;

Inhibitor titer > 10 BU at the screening visit.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SCT800 and Daratumumab
  • SCT800

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Tianjin China

Sponsors and collaborators

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Sinocelltech Ltd.

Collaborator