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.
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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

Lanlan Ji

+86-010-83575130

thigh0829@163.com

CONTACT