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A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia (ExCIT)

StatusRecruiting
PhasePhase 3
Started2026-04-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 5 of 6 changed
See other at-risk trials from Jiangsu HengRui Medicine Co., Ltd.

Amendment history

2026-10-02
critical
Primary endpoint(s) modified6 entries, revised
WasPart A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months, Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months., Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months, Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years, Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years;, Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years.
NowPart A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months., Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months., Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months., Part B: A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years., Part B: Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years., Part B: No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until the end of the primary treatment period, around 3 years.
Trial sites expanded: 7 → 51 locations
Interventions modified
2026-07-13
minor
Study Status, Contacts/Locations v2
Re-verified, no change to tracked fields
2026-04-24
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-02→confirmed 2026-04-16
Study sites0→7
2025-12-10
minor
Original filing
The ExCIT study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
Trial Details
NCT Number NCT07286032
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Patients With Chemotherapy-Induced Thrombocytopenia
Enrollment 150 participants
Start Date 2026-04-16
Primary Completion 2028-12 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-10-01