Phase
Condition
Leukemia (Pediatric)
Bone Marrow Disorder
Red Blood Cell Disorders
Treatment
SLN124
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 discontinued fromany prior cytoreductive therapy for at least 24 weeks before dosing and have recoveredfrom 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 12weeks before dosing and with no planned change in dose.
- Patients must have had a dermatological examination within 6 months prior toscreening.
- Must have an Eastern Cooperative Oncology Group score of 0, 1, or 2.
Exclusion
Exclusion Criteria:
- 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.
- Clinically significant co-morbidities
- Biochemical and hematological parameters:
- Biochemical evidence of significant liver disease during screening
- Hematological parameters at screening as follows: platelets 1,000,000/µL; orwhite blood cell (WBC) count > 25,000/µL; or peripheral blasts < 1%.
Study Design
Connect with a study center
Pindara Private Hospital
Benowa, Queensland 4217
AustraliaActive - Recruiting
Ashford Cancer Centre Research
Kurralta Park, South Australia 5037
AustraliaActive - Recruiting
Alfred Health
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Epworth HealthCare
Richmond, Victoria 3121
AustraliaActive - Recruiting
Linear Clinical Research
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
MHAT Dr Nikola Vasiliev AD
Kyustendil, 2500
BulgariaActive - Recruiting
Medical Centre Leo Clinic EOOD
Plovdiv, 4003
BulgariaActive - Recruiting
Hospital Sultanah Aminah
Johor Bahru, Johor 80100
MalaysiaActive - Recruiting
Hospital Tengku Ampuan Afzan
Kuantan, Pahang 25100
MalaysiaActive - Recruiting
Hospital Umum Sarawak
Kuching, Sarawak 93586
MalaysiaActive - Recruiting
Hospital Ampang
Ampang, Selangor 68000
MalaysiaActive - Recruiting
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu 20400
MalaysiaActive - Recruiting
Uniwersyteckie Centrum Klinlczne
Gdańsk,
PolandActive - Recruiting
PRATIA Hematologia Sp. z o. o.
Katowice,
PolandActive - Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin,
PolandActive - Recruiting
Centrum Medyczne Pratia Poznan Sp. z o. o.
Skorzewo,
PolandActive - Recruiting
Specjalistyczny Szpital Im Dra. A.
Wałbrzych, 58-300
PolandActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
Duke Cancer Institute
Durham, North Carolina 27705
United StatesSite Not Available
North Houston Cancer Clinics
Huntsville, Texas 77340
United StatesCompleted
Renovatio Clinical
The Woodlands, Texas 77380
United StatesActive - Recruiting
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