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Clinical study on efficacy and safety of hexapopal combined with all-trans retinoic acid in the treatment of recurrent ITP

Clinical study on efficacy and safety of hexapopal combined with all-trans retinoic acid in the treatment of recurrent ITP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099739
Enrollment
Unknown
Registered
2025-03-27
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Primary immune thrombocytopenia

Interventions

Group1:Hetropopar and tretinoin,24 weeks
Group2:Hetropopar and tretinoin,12 weeks

Sponsors

The First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. >=18 years old 2. Primary ITP was diagnosed 3.Previous first-line ITP drug therapy failed or relapsed 4.PLT< 30x10^9 /L 48 hours before enrollment. 5. Subjects agree to participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of secondary thrombocytopenia 2. Patients who had received hexapopal treatment before enrollment 3. Diagnosed with MF>=2 myelofibrosis according to the European Consensus Scale 4. Thrombosis tendency or arteriovenous thrombosis or other clotting disorders 5. HIV, hepatitis C or hepatitis B infection 6. Patients with malignant tumors 7. Cirrhosis or portal hypertension 8. Alanine aminotransferase or ASpartate aminotransferase was 1.5 times higher than the upper limit of normal, and total bilirubin or serum creatinine was 1.2 times higher than the upper limit of normal 9. Congestive heart failure (New York Heart Association [NYHA] Class III/IV)10 Arrhythmia, Myocardial infarction,Atrial fibrillation,Corrected QT interval extension within the last 3 months. 10.Severe allergy to the drug in this study or withdrawal from the study. 11. Pregnant or lactating women; 12.Patients with potential fertility who are reluctant to use effective contraception throughout the treatment period and at the end of the treatment period (or within 28 days after early withdrawal from the study) 13.Any other circumstances that the investigator deems inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
Platelet count;

Secondary

MeasureTime frame
The recurrence rates within the first, second, third and fourth weeks after drug withdrawal;Safety analysis;

Countries

China

Contacts

Public ContactGuo Xinhong

The First Affiliated Hospital of Xinjiang Medical University

guoxinhong222@sina.cn+86 152 9289 8288

Outcome results

None listed

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