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Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia

Study acronym: SMART
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary endpoint revised
    • Secondary endpoints: 4 to 6
    • Study description expanded, about 3 words
    v6
  2. Secondary endpoints: 3 to 4
    • Site details revised at 6 of 10 sites
    • Eligibility criteria expanded, about 2 words
    v5
  3. Site details revised at 2 of 10 sitesv4
  4. Phase: Phase 3 to Phase 4
    • Site details revised at 1 of 10 sites
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2024 to Jan 7, 2025
    • Site details revised at 10 of 10 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. Participants who do not achieve the primary endpoint at 6 months may enter a 3-month open-label extension and receive sirolimus 1.5 mg once daily, with follow-up through month 9. The main question is whether sirolimus improves the overall response rate at 6 months compared with placebo. Primary outcome: \- Overall response rate at 6 months Secondary outcomes: * Overall response rate at 1 month and 3 months * Complete response rate at 6 months * Partial response rate at 6 months * Change in anti-phospholipid antibody titers at 6 months * Change in oral glucocorticoid dosage at 6 months Exploratory outcomes: * Proportion and reasons for early discontinuation during the double-blind phase * Among participants who do not achieve the primary endpoint at 6 months and enter the open-label extension, overall response rate, complete response rate, partial response rate, and safety outcomes after 3 months of open-label treatment
Trial Details
NCT Number NCT06722586
Lead Sponsor Peking University First Hospital
Collaborators: North China Pharmaceutical Co.,Ltd
Conditions
(from sponsor)		 Antiphospholipid (aPL)-Positive, Thrombocytopaenia
Related terms Thrombocytopenia
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov