Phase
Condition
Bone Marrow Disorder
Leukemia (Pediatric)
Red Blood Cell Disorders
Treatment
SLN124
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Phase 1 and Phase 2
Inclusion Criteria:
Male and female patients aged 18 years or older.
A confirmed diagnosis of PV according to the revised 2016 World Health Organizationcriteria:
Suitable phlebotomy history
Must agree to adhere to appropriate contraception requirements
Patients who are not receiving cytoreductive therapy must have been discontinuedfrom any prior cytoreductive therapy for at least 24 weeks before dosing and haverecovered from any adverse events due to cytoreductive therapy.
Patients receiving cytoreductive therapy with hydroxyurea, interferon, busulfan orruxolitinib must have received a stable dose of cytoreductive therapy for at least 12 weeks before dosing and with no planned change in dose.
Patients must have had a dermatological examination within 28 weeks prior to dosing.
Must have an Eastern Cooperative Oncology Group score of 0, 1, or 2.
Exclusion
Exclusion Criteria:
Phase 1 and Phase 2
- Drug intolerance:
History of intolerance to oligonucleotides, or GalNAc, or any component ofSLN124.
History of intolerance to s.c. injections.
Clinically significant thrombosis (e.g., deep vein thrombosis or splenic veinthrombosis) within 12 weeks of screening.
History of major bleeding events and/or a requirement for blood transfusion therapyowing to bleeding in the last 6 months prior to screening.
Meets the criteria for post-PV myelofibrosis as defined by the International WorkingGroup-Myeloproliferative Neoplasms Research and Treatment
Any investigational drug less than 6 weeks prior to the first dose of study drug ornot recovered from effects of prior administration of any investigational agent.
Any investigational or marketed product using GalNAc targeting less than 48 weeksprior to administration of any investigational agent (excludes patients with PV whoparticipated in Phase 1 of this study).
Clinically significant co-morbidities
Biochemical and hematological parameters:
Biochemical evidence of significant liver disease during screening
Phase 1: Hematological parameters at screening as follows: platelets > 1,000,000/µL; or white blood cell (WBC) count > 25,000/µL; or peripheral blasts > 1%. b. Phase 2: Hematological parameters at screening as follows: platelets > 1,000,000/µL; or WBC count > 30,000/µL; or peripheral blasts > 1%.
Study Design
Connect with a study center
Pindara Private Hospital
Benowa, Queensland 4217
AustraliaSite Not Available
Ashford Cancer Centre Research
Kurralta Park, South Australia 5037
AustraliaSite Not Available
Alfred Health
Melbourne, Victoria 3004
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Epworth HealthCare
Richmond, Victoria 3121
AustraliaSite Not Available
Linear Clinical Research
Nedlands, Western Australia 6009
AustraliaSite Not Available
Research Site
Benowa 2176127,
AustraliaSite Not Available
Research Site
Hobart 2163355,
AustraliaSite Not Available
Research Site
Kurralta Park 8348005,
AustraliaSite Not Available
Research Site
Melbourne 2158177,
AustraliaSite Not Available
Research Site 2
Melbourne 2158177,
AustraliaSite Not Available
Linear Clinical Research
Nedlands 2064874,
AustraliaSite Not Available
Research Site
Richmond 2151649,
AustraliaSite Not Available
MHAT Dr Nikola Vasiliev AD
Kyustendil, 2500
BulgariaSite Not Available
Medical Centre Leo Clinic EOOD
Plovdiv, 4003
BulgariaSite Not Available
Research Site
Plovdiv 728193,
BulgariaSite Not Available
Research Site 2
Plovdiv 728193,
BulgariaSite Not Available
Research Site
Toronto 6167865,
CanadaSite Not Available
Research Site
Freiburg im Breisgau 2925177,
GermanySite Not Available
Research Site
Hanover 2910831,
GermanySite Not Available
Research Site
Alessandria 3183299,
ItalySite Not Available
Research Site
Meldola 3173635,
ItalySite Not Available
Hospital Sultanah Aminah
Johor Bahru, Johor 80100
MalaysiaSite Not Available
Hospital Tengku Ampuan Afzan
Kuantan, Pahang 25100
MalaysiaSite Not Available
Hospital Umum Sarawak
Kuching, Sarawak 93586
MalaysiaSite Not Available
Hospital Ampang
Ampang, Selangor 68000
MalaysiaSite Not Available
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu 20400
MalaysiaSite Not Available
Research Site
Johor Bahru 1732752,
MalaysiaSite Not Available
Research Site
Kuala Terengganu 1734705,
MalaysiaSite Not Available
Research Site
Kuantan 1735227,
MalaysiaSite Not Available
Research Site
Kuching 1735634,
MalaysiaSite Not Available
Research Site
Gdansk 3099434,
PolandSite Not Available
Uniwersyteckie Centrum Klinlczne
Gdańsk,
PolandSite Not Available
PRATIA Hematologia Sp. z o. o.
Katowice,
PolandSite Not Available
Research Site
Katowice 3096472,
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin,
PolandSite Not Available
Research Site
Lublin 765876,
PolandSite Not Available
Centrum Medyczne Pratia Poznan Sp. z o. o.
Skorzewo,
PolandSite Not Available
Specjalistyczny Szpital Im Dra. A.
Wałbrzych, 58-300
PolandSite Not Available
Research Site
Barcelona 3128760,
SpainSite Not Available
Research Site
Madrid 3117735,
SpainSite Not Available
Research Site
Hammond 4326868, Louisiana 4331987 70403
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Mount Sinai Hospital
New York, New York 10029
United StatesSite Not Available
Research Site
Buffalo 5110629, New York 5128638 14203
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Duke Cancer Institute
Durham, North Carolina 27705
United StatesSite Not Available
Research Site
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
North Houston Cancer Clinics
Huntsville, Texas 77340
United StatesSite Not Available
Renovatio Clinical
The Woodlands, Texas 77380
United StatesSite Not Available
Research Site
Huntsville 4699540, Texas 4736286 77340
United StatesSite Not Available

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