Treatment for Hemophilia A in Adolescents and Adults with High Titer Inhibitor
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
This study is testing if a new treatment for hemophilia A, using a drug called SCT800 alone or with another drug called Daratumumab, can help teenagers and adults with high titer inhibitors feel better and have fewer relapses.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Years to 65 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | Daratumumab |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT05888870 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents and adults aged 14-66 years with moderate to severe hemophilia A and confirmed high titer inhibitors.
Not a fit: Patients with contraindications to the drug ingredients, other immune diseases, or those who have previously failed systemic immune tolerance induction treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of hemophilia A in patients with high titer inhibitors, potentially leading to better long-term health outcomes.
How similar studies have performed: While there have been studies on immune tolerance induction in hemophilia A, the combination of SCT800 and Daratumumab represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.