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Not yet recruitingNCT06376435Updated Apr 19, 2024

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

An observational study in Cancer, Therapy-Related, sponsored by Hebei Medical University Fourth Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Hebei Medical University Fourth Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 75 Years
Sex
All
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Study 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.

02

Conditions studied

  • Cancer, Therapy-Related
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In context

Neoplasms, Second Primary

247 studies on the registry are indexed under Neoplasms, Second Primary; 48 are open to participants now.

This study's planned enrollment of 500 is above the median of 290 across 60 observational studies indexed under Neoplasms, Second Primary.

Browse Neoplasms, Second Primary studies →

Lead sponsor

Hebei Medical University Fourth Hospital is the lead sponsor of 78 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Single drug group

    Drug: Herombopag Olamine Tablets

  • combined rhTPO group

    Drug: Herombopag Olamine Tablets

  • combined IL-11 group

    Drug: Herombopag Olamine Tablets

Interventions

  • DrugHerombopag Olamine Tablets

    Herombopag Olamine；combined rhTPO;combined IL-11

06

What researchers measure

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

    Time frame: 14 days after starting treatment with the study drug

Secondary outcomes

  1. 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

    Time frame: up to 2 months

  2. Time for platelet recovery to 100×109/L

    Study the time for platelet recovery to 100×109/L after drug initiation

    Time frame: up to 2 months

  3. Proportion of patients with treatment delay or dose reduction

    Proportion of patients with delayed or reduced dose of radiotherapy, chemotherapy, immunosuppressants, etc

    Time frame: up to 2 months

  4. TRAE

    Study drug-related adverse reactions

    Time frame: up to 2 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06376435
Lead sponsor
Hebei Medical University Fourth Hospital
Responsible party
Jun wang (study principal investigator, Hebei Medical University Fourth Hospital) — Principal investigator
First posted
Apr 19, 2024
Start date
Apr 20, 2024 (estimated)
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Apr 19, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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