Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT07101627
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Multicenter Clinical Study of Hetrombopag in the Prevention of Thrombocytopenia Caused by Lung Cancer Therapy
Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Clinical Study of Hetrombopag in the Prevention of Thrombocytopenia Caused by Lung Cancer Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy and safety of Hetrombopag in secondary prevention of thrombocytopenia caused by lung cancer treatment
Detailed Description:
The study was divided into 2 study periods, Stage 1 was a prospective, single-arm study design and Stage 2 was a prospective, randomized, double-blind, placebo-controlled study design. According to the results of Phase 1 study, Phase 2 study design and sample size were confirmed.
Stage 1: After screening and enrollment, patients will receive oral administration of hetrombopag, 7.5 mg/day, for 14 days from the first day after the end of chemotherapy in this cycle.
Stage 2: Patients who met the inclusion criteria were randomized 1:1 to the experimental group and the control group after enrollment. Patients in the experimental group began to orally take hetrombopag 7.5 mg/day for 14 days on the first day after the end of chemotherapy in this cycle; patients in the control group began to orally take hetrombopag simulated tablets 7.5 mg/day for 14 days on the first day after the end of chemotherapy in this cycle. Randomization was stratified by concomitant immunotherapy (yes versus no) and chemotherapy with gemcitabine plus platinum (yes versus no).
Stage 1: After screening and enrollment, patients will receive oral administration of hetrombopag, 7.5 mg/day, for 14 days from the first day after the end of chemotherapy in this cycle.
Stage 2: Patients who met the inclusion criteria were randomized 1:1 to the experimental group and the control group after enrollment. Patients in the experimental group began to orally take hetrombopag 7.5 mg/day for 14 days on the first day after the end of chemotherapy in this cycle; patients in the control group began to orally take hetrombopag simulated tablets 7.5 mg/day for 14 days on the first day after the end of chemotherapy in this cycle. Randomization was stratified by concomitant immunotherapy (yes versus no) and chemotherapy with gemcitabine plus platinum (yes versus no).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: