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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06376435
Other study ID # HBHQ-CTIT-RWS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 20, 2024
Est. completion date July 1, 2026

Study information

Verified date April 2024
Source Hebei Medical University Fourth Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date July 1, 2026
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Intervention

Drug:
Herombopag Olamine Tablets
Herombopag Olamine;combined rhTPO;combined IL-11

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hebei Medical University Fourth Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of patients recovered to 100×109/L The proportion of patients who recovered to 100×109/L within 14 days after starting treatment with the drug was studied 14 days after starting treatment with the study drug
Secondary The proportion of patients recovered to 75×109/L The proportion of patients who recovered to 75×109/L after starting treatment with the drug was studied up to 2 months
Secondary Time for platelet recovery to 100×109/L Study the time for platelet recovery to 100×109/L after drug initiation up to 2 months
Secondary Proportion of patients with treatment delay or dose reduction Proportion of patients with delayed or reduced dose of radiotherapy, chemotherapy, immunosuppressants, etc up to 2 months
Secondary TRAE Study drug-related adverse reactions up to 2 months
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