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Clinical Trials List

Protocol NumberONO-0530-03-001

NCT Number(ClinicalTrials.gov Identfier)NCT07429266

Not yet recruiting

2026-07-01 - 2031-01-31

Phase III

Not yet recruiting4

A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera

Trial Applicant

WORLDWIDE CLINICAL TRIALS (TAIWAN) CO., LTD.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/09/08

Investigators and Locations

Principal Investigator 陳志丞無

Taipei Veterans General Hospital

Co-Principal Investigator

Chia-Jen Liu 無
Sheng-Hsuan Chien 無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hung Chang 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator HSIN-AN HOU 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Tsai-Yun Chen

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Polycythemia Vera

Objectives

本試驗旨在比較在真性紅血球增多症 (PV) 現有標準治療試驗計畫書 (SOC) 的基礎上搭配Sapablursen 與安慰劑在維持血細胞比容(Hct) 控制方面的療效。

Test Drug

預充填式注射劑

Active Ingredient

Sapablursen

Dosage Form

230

Dosage

0.8mL/ 80mg; 0.4mL/ 40mg

Endpoints

反應定義為從第 20 週到第 32 週期間不符合放血療法條件。
*符合以下任一條件即可進行放血療法：
- Hct ≥45%，且比基準 Hct 至少高 3%（絕對值），並以兩次連續評估確認
或
- Hct ≥48%。
我們將使用各臨床中心當地實驗室的 Hct 值作為主要評估指標，以便當天做出放血療法決定。

Inclution Criteria

Inclusion Criteria:

Meet revised 2022 World Health Organization (WHO) and 2022 International Consensus Classification criteria for the diagnosis of PV.
Participants must be phlebotomy-dependent.
Hct less than (<) 45% at study start.
Participants receiving Cytoreduction therapy (CRT) must be on a stable regimen at study start.
Adequate organ function and electrolytes.

Exclusion Criteria

Exclusion Criteria:

Prior treatment of PV with Transmembrane serine protease 6 (TMPRSS6) inhibitors, including sapablursen, or hepcidin mimetics.
Clinically significant thrombosis (eg, myocardial infarction, stroke, deep vein thrombosis or splenic vein thrombosis) within 1 month prior to randomization.
Participants who require phlebotomy at Hct levels <45%.
Meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.
Any serious or unstable medical condition or uncontrolled psychiatric condition that would interfere with their ability to comply with study requirements.

The Estimated Number of Participants

Taiwan

10 participants
Global

250 participants