NCT05130424

Brief Summary

To observe and evaluate the safety and effectiveness of herombopag in the treatment of thrombocytopenia-related diseases in Henan Province

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

October 28, 2021

Last Update Submit

November 18, 2021

Conditions

Carcinoma;Blood

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events after the treatment of Herombopag

    The investigator will observe incidence of adverse events after the treatment of Herombopag, including thrombosis, diarrhea, abnormal liver function and so on.

    From the treatment of Herombopag to 28 days after the end of the medication

Secondary Outcomes (2)

  • Changes of the platelet counts after the treatment of Herombopag

    From the treatment of Herombopag to 28 days after the end of the medication

  • Proportion of patients with platelet transfusion

    From the treatment of Herombopag to 28 days after the end of the medication

Interventions

HerombopagDRUG

Herombopag in the treatment of thrombocytopenia-related diseases Non-interventional clinical research.Do not interfere with the dosage and market of Hetrobopar Oral medication

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with thrombocytopenia-related diseases

You may qualify if:

  • Thrombocytopenia related diseases;
  • Volunteer to join this study and sign an informed consent form;
  • Clinical evaluation can benefit from Herombopag.

You may not qualify if:

  • Those who have been confirmed to be allergic to Herombopag and/or its excipients;
  • Pregnant or breastfeeding women;
  • Except for patients with contraindications to Herombopag;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

suxia luo

CONTACT

18638553211luosxrm@163.com

wenying deng

CONTACT

15837168169psc1969@sohu.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 23, 2021

Study Start

September 29, 2021

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

CN(1)