Clinical 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 Non-randomized Controlled Trial
Name
SCT800-AITI
Description
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.
Trial arms
Trial start
2023-11-22
Estimated PCD
2026-12-01
Trial end
2026-12-01
Status
Recruiting
Phase
Early phase I
Treatment
SCT800 and Daratumumab
SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
Arms:
SCT800 combined with Daratumumab
Other names:
Immune tolerance induction combine anti-CD38
SCT800
SCT800 50IU/kg TIW alone
Arms:
SCT800 alone
Other names:
Immune tolerance induction only
Size
50
Primary endpoint
success rate of ITI success rate of ITI success rate of ITI success rate of ITI
12 months
Success rate and partial success rate of ITI after 3-month treatment
3 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-01-12
1 organization
1 product
1 indication
Product
SCT800Indication
Hemophilia A with inhibitor