NCT05160857

Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Hospital of Shanxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, single center and exploratory clinical study, which aims to explore the efficacy and safety of hetropapa ethanolamine tablets in the treatment of thrombocytopenia caused by concurrent radiotherapy and chemotherapy of cervical cancer. The primary end point was the proportion of subjects who were effective after treatment with hetropapa in the first cycle after treatment, that is, the platelet value recovered to ≥ 100 x 109 / L after treatment. The main inclusion criteria were: voluntary participation in the trial and signing informed consent; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet \< 75 × 109/L； At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle.

Conditions

• Tumor Chemotherapy-related Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Herombopag Olamine	The initial dose of hetropapa is recommended to be 7.5mg, once a day, oral on an empty stomach, and can only be eaten after oral administration for 2 hours, so as to avoid taking it with meals.

Timeline

• Start date: 2021-12-31
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-12-16
• Last updated: 2021-12-16

Locations

1 site across 1 country: China