A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia

Not yet recruiting

• Conditions: Cancer, Therapy-Related
• Interventions: Drug: Herombopag Olamine Tablets

• Registration Number: NCT06376435
• Lead Sponsor: Hebei Medical University Fourth Hospital

Brief Summary

The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world.

The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia.

This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values \< 100×109/L during radioimmunotherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Study Start: 2024-04-20
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Understand the research procedure and voluntarily sign the informed consent to participate in the study
• Subjects ≥18 years of age receiving synchronous/sequential chemotherapeutic therapy
• Patients with platelet count ≤100×109/L or platelet count decrease ≥ 50×109/L or platelet count > 100×109/L but need to be prophylaxis with hexapopethanolamine tablets
• Researchers believe that subjects need to be treated with hexapopal.

Exclusion Criteria

• The subjects are conducting clinical intervention studies
• Patients with known or expected allergy or intolerance to the active ingredient or excipient of hexapopar
• Pregnant or lactating women
• Other conditions deemed unsuitable for inclusion in the study by the researcher.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single drug group	Herombopag Olamine Tablets	-
combined rhTPO group	Herombopag Olamine Tablets	-
combined IL-11 group	Herombopag Olamine Tablets	-

Primary Outcome Measures

Name	Time	Method
The proportion of patients recovered to 100×109/L	14 days after starting treatment with the study drug	The proportion of patients who recovered to 100×109/L within 14 days after starting treatment with the drug was studied

Secondary Outcome Measures

Name	Time	Method
The proportion of patients recovered to 75×109/L	up to 2 months	The proportion of patients who recovered to 75×109/L after starting treatment with the drug was studied
Proportion of patients with treatment delay or dose reduction	up to 2 months	Proportion of patients with delayed or reduced dose of radiotherapy, chemotherapy, immunosuppressants, etc
Time for platelet recovery to 100×109/L	up to 2 months	Study the time for platelet recovery to 100×109/L after drug initiation
TRAE	up to 2 months	Study drug-related adverse reactions