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.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Gao-Jun Teng
- 전화번호: +86-02583272121
- 이메일: gjteng@vip.sina.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental arm (N=72)
Hetrombopag 10 mg once daily for 5 consecutive days. |
Hetrombopag 10 mg orally once daily for 5 consecutive days |
|
위약 비교기: Control arm (N=36)
|
Placebo 10 mg orally once daily for 5 consecutive days. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively and no rescue bleeding treatment within 7 days postoperatively.
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Gao-jun Teng, Zhongda hospital, Southeast university, Nanjing, China
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026ZDSYLL341-Y01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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