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An open-label, single-arm study of Herombopag Olamine for the treatment of thrombocytopenia caused by PARPi

An open-label, single-arm study of Herombopag Olamine for the treatment of thrombocytopenia caused by PARPi

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088126
Enrollment
Unknown
Registered
2024-08-12
Start date
2023-05-23
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

experimental group:This study is divided into a treatment phase and a maintenance phase. During the treatment phase, the initial dose of Herombopag Olamine is 5 mg once daily, taken 2 hours before mea

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age =18 years; Thrombocytopenia induced by the use of PARPi Platelet count 20×10^9/L = PLT = 75×10^9/L, and still using PARPi within three days before enrollment No dose delays or adjustments for PARPi at the time of enrollment; Normal hematopoiesis, liver and kidney function; Exclusion of patients with decreased total blood cell count (hemoglobin <8.0gm/dL or ANC < 1000/uL); ECOG performance status: 0-2; Signed informed consent.

Exclusion criteria

Exclusion criteria: Previous use of TPO-RA drugs, excluding rh-TPO; Uncontrollable active infections; Subjects with radiation therapy and bone marrow infiltration; Individuals with bleeding tendencies, evidence of hereditary bleeding diathesis or coagulation disorders; Pregnant or lactating women, or female patients of childbearing potential not using contraception; Participation in another drug clinical trial within 4 weeks; Patients with uncontrollable neurological, psychiatric diseases or mental disorders, poor compliance, unable to cooperate or report treatment responses; Individuals allergic to the study drug.

Design outcomes

Primary

MeasureTime frame
Platelets;

Secondary

MeasureTime frame
The time required for PLT recovery;

Countries

China

Contacts

Public ContactJu Xingzhu

Fudan University Shanghai Cancer Center

xingzhu_ju@163.com+86 21 6417 5590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026