Trial Profile
A Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Subjects With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 06 Feb 2023
Price :
$35
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At a glance
- Drugs Ibrutinib (Primary) ; Fluconazole; Voriconazole
- Indications Graft-versus-host disease
- Focus Registrational; Therapeutic Use
- Sponsors Janssen Pharmaceutical KK
- 30 Dec 2021 Status changed from active, no longer recruiting to completed.
- 01 Oct 2021 Primary endpoint (Percentage of Participants who Achieve Complete Response (CR) or Partial Response (PR) (i.e. Overall Response Rate [ORR]) has been met according to the results published in the Transplantation and Cellular Therapy
- 01 Oct 2021 Interim results (data cut off: January 21, 2020) assessing efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ibrutinib in steroid-dependent/refractory cGVHD patients published in the Transplantation and Cellular Therapy