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New treatment option for Hemophilia A With Inhibitor
Official title ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
ClinicalTrials.gov ID: NCT05888870
What this study is testing
What is SCT800 and Daratumumab?
SCT800 and Daratumumab is an investigational medicine, being studied as a potential treatment for hemophilia a with inhibitor.
Also referred to as Immune tolerance induction combine anti-CD38.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 65
You may be able to join if
- Moderate or severe hemophilia A;
- Aged 14-66 years old;
- Inhibitor positive at 2 consecutive visits;
- Inhibitor titer \> 10 BU at the screening visit.
You likely can't join if
- 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;
- The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.