Hetrombopag for Thrombocytopenia in Patients Scheduled for Elective Hepatic Interventional Diagnostic and Therapeutic Procedures: A Clinical Study
2 novembre 2026 mis à jour par: Gao-jun Teng, Zhongda Hospital
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
108
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Gao-Jun Teng
- Numéro de téléphone: +86-02583272121
- E-mail: gjteng@vip.sina.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Experimental arm (N=72)
Hetrombopag 10 mg once daily for 5 consecutive days. |
Hetrombopag 10 mg orally once daily for 5 consecutive days |
|
Comparateur placebo: Control arm (N=36)
|
Placebo 10 mg orally once daily for 5 consecutive days. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively and no rescue bleeding treatment within 7 days postoperatively.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Gao-jun Teng, Zhongda hospital, Southeast university, Nanjing, China
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 octobre 2026
Achèvement primaire (Estimé)
15 septembre 2027
Achèvement de l'étude (Estimé)
30 août 2028
Dates d'inscription aux études
Première soumission
13 octobre 2026
Première soumission répondant aux critères de contrôle qualité
2 novembre 2026
Première publication (Réel)
9 novembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 novembre 2026
Dernière vérification
1 octobre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026ZDSYLL341-Y01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .