Hetrombopag for Thrombocytopenia in Patients Scheduled for Elective Hepatic Interventional Diagnostic and Therapeutic Procedures: A Clinical Study
A Clinical Study to Evaluate the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia in Patients Undergoing Elective Hepatic Interventional Diagnostic and Therapeutic Procedures
This is a prospective, multicenter, open-label, randomized controlled clinical study. It includes three phases: screening period, treatment period and follow-up period. A total of 108 adult patients with thrombocytopenia (PLT < 50×10⁹/L) scheduled for elective hepatic interventional procedures will be enrolled.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Gao-Jun Teng
- 電話番号：+86-02583272121
- メール：gjteng@vip.sina.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients aged ≥ 18 years
- Child-Pugh class A or B
- Baseline platelet count (PLT) < 50 × 10⁹/L
- Scheduled for elective liver interventional procedures meeting the following criteria: performed between Day 7 and Day 15 after enrollment, including mainly transvascular interventional procedures (TACE/HAIC ± systemic anti-tumor therapy, TAE, Yttrium-90 radioembolization, TIPS, PTVE, etc.) and percutaneous non-vascular interventional procedures (RFA, MWA, cryoablation, liver biopsy, etc.)
- ECOG performance status 0 or 1
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, not be breastfeeding, and must agree to use effective contraception throughout the study period and for 7 days after the last dose of study drug
- Voluntarily participating in this study, providing signed informed consent, and having good compliance
Exclusion Criteria:
- Presence of other diseases that may cause thrombocytopenia, including but not limited to: aplastic anemia, myelodysplastic syndromes, chronic myeloproliferative neoplasms, congenital thrombocytopenia, drug-induced thrombocytopenia, immune thrombocytopenia, thrombocytopenia secondary to rheumatic immune diseases, etc.
- Previous or current arterial or venous thrombosis, including partial or complete thrombosis
- History of portal vein thrombosis and/or main portal vein tumor thrombus; and/or evidence of portal vein thrombosis on ultrasound, CT, or MRI during screening; and/or absence of hepatopetal portal venous flow on Doppler ultrasound; and/or portal venous flow velocity < 10 cm/s
- Scheduled for open abdominal surgery such as hepatectomy or liver transplantation
- Received platelet-increasing procedures within 90 days prior to randomization, including partial splenic artery embolization, splenic radiofrequency/microwave ablation, high-intensity focused ultrasound (HIFU) of the spleen, three-dimensional conformal therapy of the spleen, etc.
- Previous history of liver transplantation or splenectomy
- At screening, any of the following: significant liver function abnormality with ALT/AST >3×ULN or TBL >2×ULN; hepatic encephalopathy with Child-Pugh hepatic encephalopathy score of 3 (occasional coma), irrespective of hepatic encephalopathy treatment; medication-refractory ascites
- Bleeding score ≥ grade 2 according to the WHO bleeding scale prior to randomization, or history or evidence of diseases with bleeding risk
- Received platelet transfusion or platelet-containing blood products (excluding red blood cells) within 3 days prior to randomization
- Received any of the following medications within 14 days prior to randomization: TPO (e.g., rhTPO), other TPO-RA agents, recombinant human interleukin-11 (IL-11), etc.
- Any other condition deemed unsuitable for inclusion in the study by the investigator
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Experimental arm (N=72)
Hetrombopag 10 mg once daily for 5 consecutive days. |
Hetrombopag 10 mg orally once daily for 5 consecutive days |
|
プラセボコンパレーター：Control arm (N=36)
|
Placebo 10 mg orally once daily for 5 consecutive days. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively and no rescue bleeding treatment within 7 days postoperatively.
時間枠：Perioperative, up to postoperative Day 7
|
The primary endpoint is the percentage of subjects who achieve platelet count ≥50×10⁹/L within 24 hours before operation and do not receive rescue treatment for bleeding during the first 7 days after surgery. |
Perioperative, up to postoperative Day 7
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively.
時間枠：Within 24 hours before surgery
|
The percentage of subjects whose platelet count reaches ≥50×10⁹/L within 24 hours before surgery. |
Within 24 hours before surgery
|
|
The proportion of participants with an increase in PLT ≥20×10⁹/L from baseline at 24 hours preoperatively.
時間枠：Baseline and within 24 hours before surge
|
The percentage of subjects with platelet count elevation of at least 20×10⁹/L compared with baseline at 24 hours before surgery. |
Baseline and within 24 hours before surge
|
|
The proportion of participants without platelet transfusion during the study period.
時間枠：Through study completion, an average of 35 days
|
The percentage of subjects who do not receive any platelet transfusion throughout the study. |
Through study completion, an average of 35 days
|
|
Duration of platelet count maintaining PLT ≥50×10⁹/L.
時間枠：Through study completion, an average of 35 days
|
The length of time that platelet count remains at or above 50×10⁹/L. |
Through study completion, an average of 35 days
|
|
Change in platelet count at different visit time points.
時間枠：Baseline and at all scheduled study visits through study completion, an average of 35 days
|
The change from baseline in platelet count assessed at each scheduled study visit. |
Baseline and at all scheduled study visits through study completion, an average of 35 days
|
|
The proportion of participants without delay, cancellation or discontinuation of systemic anti-tumor therapy due to thrombocytopenia.
時間枠：Through study completion, an average of 35 days
|
The percentage of subjects whose systemic anti-tumor therapy is not delayed, cancelled or discontinued because of thrombocytopenia. |
Through study completion, an average of 35 days
|
|
The proportion of participants requiring rescue treatment for bleeding.
時間枠：Through study completion, an average of 35 days
|
The percentage of subjects who receive rescue therapy for bleeding events. |
Through study completion, an average of 35 days
|
|
Number and dose of platelet transfusions.
時間枠：Through study completion, an average of 35 days
|
The total number and administered dose of platelet transfusions received by subjects during the study. |
Through study completion, an average of 35 days
|
|
Number of participants with at least one treatment-related adverse event, clinically significant laboratory abnormality or vital sign abnormality assessed by CTCAE v5.0
時間枠：Through study completion, an average of 35 days
|
The count of subjects who develop at least one treatment-related adverse event, clinically significant laboratory abnormality or abnormal vital sign. |
Through study completion, an average of 35 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Gao-jun Teng、Zhongda hospital, Southeast university, Nanjing, China
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026ZDSYLL341-Y01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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