| Title |
A Phase 2a, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered to Patients With Phlebotomy Dependent Polycythemia Vera (PD-PV) |
| Protocole ID |
ISIS 702843-CS4 |
| ClinicalTrials.gov ID |
NCT05143957 |
| Cancer Type(s) |
MPN: Vaquez, Essential Thrombocytemia, Myeloid Metaplasia |
| Phase |
Phase II |
| Stage |
|
| Study Type |
Clinical |
| Drug |
IONIS-TMPRSS6-LRx |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| City |
|
| Principal Investigator |
Dr. Jonathan How
|
| Coordinator |
Judit Kokai
438-888-1582
|
| Status |
Recruiting |
| Activation Date |
25-08-2022 |
| Eligibility Criteria |
- Meet modified World Health Organization (WHO) 2016 diagnostic criteria for polycythemia vera (PV) at the time of clinical diagnosis
- Participant must be phlebotomy dependent.
- If the participant is currently on cytoreductive therapy or has been previously treated with cytoreductive therapy, the participant's cytoreductive therapy must either be discontinued at least 3 months prior to Screening, OR participant must be on a stable dose for at least 3 months prior to Screening.
|
| Exclusion Criteria |
- Meets criteria for post-polycythemia vera myelofibrosis (PPV-MF) as defined by the International Working Group- Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
- Moderate to severe splenic pain or spleen-related organ obstruction
- Active or chronic bleeding within 1 month of Screening, significant concurrent/recent coagulopathy, history of immune thrombocytopenic purpura (ITP)
- Known primary or secondary immunodeficiency
- Active infection with human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.
- Active infection requiring systemic antiviral or antimicrobial therapy or active novel coronavirus disease (Covid-19) infection
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or non-metastatic prostate cancer that has been successfully treated
- Surgery requiring general anesthesia within 1 month prior to Screening
|
| |
|
Groupe d'étude en oncologie du Québec