Managed Access Programs for INC424, Ruxolitinib

• Conditions: Primary Myelofibrosis (PMF); Post Polycythemia Myelofibrosis (PPV MF); Thrombocythemia Myelofibrosis (PET-MF); Severe/very Severe COVID-19 Illness; Polycythemia Vera (PV); Steroid Refractory Acute Graft Versus Host Disease (SR AGVHD); Steroid Refractory Chronic Graft Versus Host Disease (SR CGVHD)

• Registration Number: NCT04745637
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib

Detailed Description

CINC424A2405 - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CINC424A2405 to provide access to Ruxolitinib for patients with Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF)

CINC424A2001M - No longer available - Ruxolitinib Managed Access Program (MAP) for patients diagnosed with severe/very severe COVID-19 illness

CINC424B2002I - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CINC424B2002I to provide access to Ruxolitinib for patients with Polycythemia Vera (PV)

CINC424C2001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424C2001M to provide access to ruxolitinib for steroid refractory acute and chronic Graft versus Host Disease (SR aGVHD and SR cGHVD).

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-09
• Status Verified: 2024-10
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified