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

April 18, 2024 updated by: Jun wang, Hebei Medical University Fourth Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single drug group
Drug: Herombopag Olamine Tablets
Herombopag Olamine；combined rhTPO;combined IL-11
combined rhTPO group
Drug: Herombopag Olamine Tablets
Herombopag Olamine；combined rhTPO;combined IL-11
combined IL-11 group
Drug: Herombopag Olamine Tablets
Herombopag Olamine；combined rhTPO;combined IL-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients recovered to 100×109/L
Time Frame: 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
14 days after starting treatment with the study drug

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Fourth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBHQ-CTIT-RWS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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