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

NCT06376435 | Not Yet Recruiting

• 1 other identifier: HBHQ-CTIT-RWS
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer, Therapy-Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The proportion of patients recovered to 75×109/L

  up to 2 months

• Time for platelet recovery to 100×109/L

  up to 2 months

• Proportion of patients with treatment delay or dose reduction

  up to 2 months

• TRAE

  up to 2 months

Study Arms (3)

Single drug group

Drug: Herombopag Olamine Tablets

combined rhTPO group

Drug: Herombopag Olamine Tablets

combined IL-11 group

Drug: Herombopag Olamine Tablets

Interventions

Herombopag Olamine Tablets DRUG

Herombopag Olamine；combined rhTPO;combined IL-11

Single drug group; combined IL-11 group; combined rhTPO group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with solid malignancies undergoing radiotherapy/chemotherapy/immunosuppressant induced thrombocytopenia

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

MeSH Terms

Conditions

Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study principal investigator

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 19, 2024
• Study Start: April 20, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04