Hetrombopag for Thrombocytopenia in Patients Scheduled for Elective Hepatic Interventional Diagnostic and Therapeutic Procedures: A Clinical Study
2 novembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
108
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Gao-Jun Teng
- Numero di telefono: +86-02583272121
- Email: gjteng@vip.sina.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Experimental arm (N=72)
Hetrombopag 10 mg once daily for 5 consecutive days. |
Hetrombopag 10 mg orally once daily for 5 consecutive days |
|
Comparatore placebo: Control arm (N=36)
|
Placebo 10 mg orally once daily for 5 consecutive days. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively and no rescue bleeding treatment within 7 days postoperatively.
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Gao-jun Teng, Zhongda hospital, Southeast university, Nanjing, China
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 ottobre 2026
Completamento primario (Stimato)
15 settembre 2027
Completamento dello studio (Stimato)
30 agosto 2028
Date di iscrizione allo studio
Primo inviato
13 ottobre 2026
Primo inviato che soddisfa i criteri di controllo qualità
2 novembre 2026
Primo Inserito (Effettivo)
9 novembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 novembre 2026
Ultimo verificato
1 ottobre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026ZDSYLL341-Y01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .