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Efficacy and safety of Hetrepopal for platelet reconstruction in hematopoietic stem cell transplantation

Efficacy and safety of Hetrepopal for platelet reconstruction in hematopoietic stem cell transplantation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060057
Enrollment
Unknown
Registered
2022-05-16
Start date
2022-05-05
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Thrombocytopenia after hematopoietic stem cell transplantation

Interventions

Treatment group:Herombopag
Control group:Recombinant human thrombopoietin

Sponsors

Zigong First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. All patients (>=14 years old) receiving HSCT; 2. The parameters of serum prothrombin time (PT), activated partial thrombin time (aPTT), FIB-C, D-dimer, glutamate-pyruvate aminotransferase (ALT), Glutamate-oxaloacetic aminotransferase (AST), total bilirubin (TBIL), direct bilirubin (DBIL), blood urea nitrogen (BUN) and serum creatinine (Scr) were less than 2.5 times of the upper limit of normal; 3. The investigator determined that the patient could receive hexapopal administration; 4. No serious underlying diseases; 5. No severe active infection.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating subjects; 2. Failure to understand the nature of the study or to obtain informed consent; 3. Severe heart, kidney or liver insufficiency; 4. Other situations deemed unsuitable for inclusion in the study by the researcher; 5. Subjects who did not meet inclusion criteria or experienced a serious adverse event (grade 4 or 5) during conditioning, as defined by the Standard for Common Terminology for Adverse Events.

Design outcomes

Primary

MeasureTime frame
The time nodes of >=20X10^9/L, 50X10^9/L and 100X10^9/L after platelet implantation were observed;

Countries

China

Contacts

Public ContactXiao Jian

Zigong First People's Hospital

16188702@qq.com+86 15881327002

Outcome results

None listed

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