Treatment for Hemophilia A in Adolescents and Adults with High Titer Inhibitor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of immune tolerance induction therapy using SCT800 alone or in combination with Daratumumab in adolescents and adults with hemophilia A who have high titer inhibitors. It is a non-randomized controlled trial that aims to compare the response time, sustained remission rates, and relapse rates between the two treatment approaches. Participants will receive either SCT800 alone or SCT800 combined with Daratumumab to determine which method yields better outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Lei Zhang — Chinese Academy of Medical Science and Blood Disease Hospital
• Study coordinator: Wei Liu
• Email: liuwei1@ihcams.ac.cn
• Phone: +8613820261971

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.