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

H

Hebei Medical University

Status

Not yet enrolling

Conditions

Cancer, Therapy-Related

Treatments

Drug: Herombopag Olamine Tablets

Study type

Observational

Funder types

Other

Identifiers

NCT06376435
HBHQ-CTIT-RWS

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

500 participants in 3 patient groups

Single drug group
Treatment:
Drug: Herombopag Olamine Tablets
combined rhTPO group
Treatment:
Drug: Herombopag Olamine Tablets
combined IL-11 group
Treatment:
Drug: Herombopag Olamine Tablets

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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