Clinical Study on Efficacy and Safety of Hetrombopag in t... | NCT06562738

Studies
Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia

NCT06562738

Sponsor

The Third People's Hospital of Chengdu

Status

Recruiting

Last Update Posted

Aug 20, 2024Actual

Enrollment

55Estimated

Phase

Phase 4

Conditions

Thrombocytopenia

Interventions

Hetrombopag

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Jan 31, 2025Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Aug 13, 2024

First Submission Date that Met QC Criteria

Aug 17, 2024

First Posted Date

Aug 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2024

Last Update Posted Date

Aug 20, 2024Actual

Name	Class
Afﬁliated Hospital of North Sichuan Medical College	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery

Detailed Description

It was planned to include 55 patients with immune thrombocytopenia with preoperative platelet ≤75×10^9/L. After signing the informed consent letter, the patients will enter the screening period (up to 7 days), and after passing the screening, they will receive oral hexapopal treatment, the specific medication regimen is: 7.5mg, once a day, taken orally on an empty stomach before going to bed, for a maximum of 14 days, and stop the drug when PLT≥100×10^9/L. During the oral administration of hexapopal, the administration was suspended when PLT≥200×10^9/L, and continued when the blood image was monitored weekly until PLT < 100×10^9/L. During the treatment period, blood routine was monitored every 7 days, and when PLT≤30×10^9/L or ≥300×10^9/L, blood routine was monitored every 3 days. Patients will have an end-of-treatment visit within 7 days of stopping treatment, followed by a 30-day safe follow-up period.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental: Hetrombopag arm	Experimental	Takes Hetrombopag 7.5 mg/day at bedtime for at most 14 days.	Drug: Hetrombopag

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hetrombopag	Drug	Hetrombopag 7.5 mg, once a day, at bedtime for up to 14 days, drug administration was stopped when PLT≥100 ×10^9/L, and take blood routine examination weekly, drug administration was resumed when PLT < 100 ×10^9/L. When PLT ≤30× 10^9/L or ≥300 ×10^9/L, take blood routine examination every 3 days.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Platelet elevation	Proportion of patients achieving perioperative platelet count goals (≥80×10^9/ L for major surgery and ≥50×10^9/ L for minor surgery) without emergency treatment	up to 14 days

Secondary Outcomes

Measure	Description	Time Frame
Secondary Outcome	The median time to reach the platelet count target;	up to 14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years old; diagnosis of immune thrombocytopenia.
Platelets ≤75×10^9/L before scheduled elective surgery.

Exclusion Criteria:

History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;
Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;
Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);
Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;
New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure;
History of angina pectoris, myocardial infarction or cerebral infarction within 6 months before the screening period;
Have an active infection that is difficult to control;
Pregnant or lactating women;
Other conditions determined by the investigator to be unsuitable for inclusion in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ying Li, PhD	Contact	+86 028 61318717		79468064@qq.com
Zuofeng Liu, Master	Contact	+86 028 61318717		641206088@qq.com

Overall Officials

Name	Affiliation	Role
JING TAN, MD	成都市第三人民医院	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chengdu Third People's Hospital	Recruiting	Chengdu	Sichuan	610000	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 30, 2023	Feb 19, 2024	Prot_000.pdf
ICF	No	No	Yes	Informed Consent Form	Dec 30, 2023	Feb 19, 2024	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D013921	Thrombocytopenia

Ancestor Terms

ID	Term
D001791	Blood Platelet Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000095542	Cytopenia

Browse Leaves

Not provided

Browse Branches

Not provided