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

2. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

108

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Experimental arm (N=72)

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

Hetrombopag 10 mg orally once daily for 5 consecutive days
Placebo komparator: Control arm (N=36)
Legemiddel: Placebo

Placebo 10 mg orally once daily for 5 consecutive days.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively and no rescue bleeding treatment within 7 days postoperatively.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Zhongda Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. oktober 2026

Primær fullføring (Antatt)

15. september 2027

Studiet fullført (Antatt)

30. august 2028

Datoer for studieregistrering

Først innsendt

13. oktober 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

9. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026ZDSYLL341-Y01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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