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Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP)

NCT06287567 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-12-19

No results posted yet for this study

Summary

This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy

Conditions

Interventions

DRUG

Lusutrombopag Oral Tablet

Participants receive lusutrombopag 3 mg administered orally once a day for up to 4 weeks and doses are adjusted based on platelet counts during week 5-12. If a subject's platelet count remains \< 50x10\^9 /L, the dose could have been increased up to a maximum dose of 6 mg（2 tablets).If a subject's platelet count reaches ≥ 250x10\^9 /L during the first 4 weeks, treatment is stopped and participants are allowed to enter into Titration Study in advance when platelet count drops to ≥100x10\^9 /L.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Zhang Lei, MD · Chinese Academy of Medical Science and Blood Disease Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-17
Primary Completion
2024-11-13
Completion
2025-03-06
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06287567 on ClinicalTrials.gov