Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia
Recruiting
Phase 4
Interventional Study
Antiphospholipid (aPL)-Positive
Thrombocytopaenia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 84 (estimated)
- Sponsor
- Peking University First Hospital · Other
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About This Trial
The goal of this clinical trial is to evaluate the efficacy and safety of sirolimus in patients with anti-phospholipid antibody-associated thrombocytopenia.
In the 6-month randomized, double-blind, placebo-controlled phase, participants will receive either sirolimus 1 mg once daily or matching placebo. Participants will be followed at 2 weeks, 1 month, 3 months, and 6 months after enrollment.
Pa…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* persistent positive of antiphospholipid antibody (either lupus anticoagulant, anti-cardiolipin antibody, or anti-b2GP1 antibody, at least two times with 12 weeks apart)
* persistent thrombocytopenia (30-100×10\^9/L, at least for 2 weeks)
Eligible concomitant treatment:
* pre…
Contacts