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Managed Access Programs for INC424, Ruxolitinib

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Expanded Access
Eligible Ages	2 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion criteria. 1. An independent request was received from a licensed physician. 2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. 3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial. 4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. 5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). 6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program. 7. Managed Access provision is allowed per local laws/regulations.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04745637
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Available
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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)

Additional Details

CINC424A2405

- 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

- 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).

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs

[email protected]

1-88-669-6682

For additional contact information, you can also visit the trial on clinicaltrials.gov.