Status:

UNKNOWN

Sirolimus Combined With Low-dose Warfarin for the Treatment of Refractory PNH

Lead Sponsor:

Peking Union Medical College Hospital

Conditions:

Paroxysmal Nocturnal Hemoglobinuria

Eligibility:

All Genders

18-70 years

Phase:

PHASE4

Brief Summary

Classical paroxysmal nocturnal hemoglobinuria(PNH) is mainly characterized by hemolysis and thrombosis, which reduced patients ' quality of life(QoL) greatly and even lead to death. Glucocorticoids an...

Detailed Description

Classical paroxysmal nocturnal hemoglobinuria(PNH) is mainly characterized by hemolysis and thrombosis, which reduced patients ' quality of life(QoL) greatly and even lead to death. There is no ideal ...

Eligibility Criteria

Inclusion

  • age 18-70 years
  • diagnosed with PNH and no thrombosis
  • ineffective, relapsed or intolerant to conventional treatment (eg glucocorticoids, • • iron, folic acid, androgen, etc.)
  • not available for hematopoietic stem cell transplantation
  • ECOG≤2
  • agreed to sign the consent forms

Exclusion

  • severe heart, liver and kidney dysfunction
  • combined with thrombotic complications
  • people who are pregnant and breastfeeding
  • history of other immunosuppressive agents in recent 3 months
  • Patients who are not eligible to participate in this trial due to any reason based • • • on the consideration of investigator

Key Trial Info

Start Date :

April 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2022

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03866681

Start Date

April 1 2019

End Date

April 1 2022

Last Update

March 8 2019

Active Locations (1)

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Peking union medical college hospital

Beijing, China