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Hetrombopag for Thrombocytopenia in Patients Scheduled for Elective Hepatic Interventional Diagnostic and Therapeutic Procedures: A Clinical Study

2 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

108

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Experimental arm (N=72)

Hetrombopag 10 mg once daily for 5 consecutive days.
Geneesmiddel: Hetrombopag

Hetrombopag 10 mg orally once daily for 5 consecutive days
Placebo-vergelijker: Control arm (N=36)
Geneesmiddel: Placebo

Placebo 10 mg orally once daily for 5 consecutive days.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively and no rescue bleeding treatment within 7 days postoperatively.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zhongda Hospital

Onderzoekers

  • Hoofdonderzoeker: Gao-jun Teng, Zhongda hospital, Southeast university, Nanjing, China

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 oktober 2026

Primaire voltooiing (Geschat)

15 september 2027

Studie voltooiing (Geschat)

30 augustus 2028

Studieregistratiedata

Eerst ingediend

13 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2026

Eerst geplaatst (Werkelijk)

9 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026ZDSYLL341-Y01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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