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

ConditionHemophilia A With 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SCT800 and Daratumumab

    Drug

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

  • SCT800

    Drug

    SCT800 50IU/kg TIW alone

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: SCT800 combined with DaratumumabExperimental treatment 1 intervention
Group B: SCT800 aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

success rate of ITI success rate of ITI success rate of ITI success rate of ITI

Inhibitor titre \<0.6 BU⁄mL

Time frame
12 months
2

Success rate and partial success rate of ITI after 3-month treatment

Inhibitor titre \<0.6 BU⁄mL

Time frame
3 months

Secondary outcomes

1

ITI success time

time to successful tolerance

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Sinocelltech Ltd.

Collaborator

Source ClinicalTrials.gov
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