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Brief Title: Study to Assess SLN124 in Patients With Polycythemia Vera
Official Title: Phase 1/2 Study With an Open-label Dose Escalation Phase Followed by a Randomized, Double-blind Phase of SLN124 in Patients With Polycythemia Vera
Study ID: NCT05499013
Brief Summary: This is a Phase 1/2, multicenter study with an open-label dose escalation followed by a randomized placebo controlled and double-blind phase of SLN124 in adult patients with Polycythemia Vera (PV) to assess the safety, tolerability, efficacy, pharmacokinetic (PK), and Pharmacodynamic (PD) response of SLN124.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Michigan, Ann Arbor, Michigan, United States
Mount Sinai Hospital, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
North Houston Cancer Clinics, Huntsville, Texas, United States
Renovatio Clinical, The Woodlands, Texas, United States
Pindara Private Hospital, Benowa, Queensland, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Alfred Health, Melbourne, Victoria, Australia
Epworth HealthCare, Richmond, Victoria, Australia
Linear Clinical Research, Nedlands, Western Australia, Australia
MHAT Dr Nikola Vasiliev AD, Kyustendil, , Bulgaria
Medical Centre Leo Clinic EOOD, Plovdiv, , Bulgaria
Hospital Sultanah Aminah, Johor Bahru, Johor, Malaysia
Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Malaysia
Hospital Umum Sarawak, Kuching, Sarawak, Malaysia
Hospital Ampang, Ampang, Selangor, Malaysia
Hospital Sultanah Nur Zahirah, Kuala Terengganu, Terengganu, Malaysia
Uniwersyteckie Centrum Klinlczne, Gdańsk, , Poland
PRATIA Hematologia Sp. z o. o., Katowice, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie, Lublin, , Poland
Centrum Medyczne Pratia Poznan Sp. z o. o., Skorzewo, , Poland
Specjalistyczny Szpital Im Dra. A., Wałbrzych, , Poland