A Real-world Study of Herombopag in the Treatment of Thrombocytopenia Related Diseases in Henan Province

Sponsor
SuxiaLuo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05130424
Collaborator
(none)
498
1
23.1
21.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Detailed Description

This study is designed as a real-world study on the treatment of thrombocytopenia-related diseases with Herombopag, to observe and analyze the safety and efficacy of Herombopag for thrombocytopenia-related diseases in the real world.

Study Design

Study Type:
Observational
Anticipated Enrollment :
498 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Real-world Study of Herombopag in the Treatment of Thrombocytopenia Related Diseases in Henan Province
Actual Study Start Date :
Sep 29, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events after the treatment of Herombopag [From the treatment of Herombopag to 28 days after the end of the medication]

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

Secondary Outcome Measures

  1. Changes of the platelet counts after the treatment of Herombopag [From the treatment of Herombopag to 28 days after the end of the medication]

    The investigator will assess the changes of the platelet counts after the treatment of Herombopag。

  2. Proportion of patients with platelet transfusion [From the treatment of Herombopag to 28 days after the end of the medication]

    The investigator will assess the proportion of patients with platelet transfusion after the treatment of Herombopag。

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Thrombocytopenia related diseases;

  2. Volunteer to join this study and sign an informed consent form;

  3. Clinical evaluation can benefit from Herombopag.

Exclusion Criteria:
  1. Those who have been confirmed to be allergic to Herombopag and/or its excipients;

  2. Pregnant or breastfeeding women;

  3. Except for patients with contraindications to Herombopag;

  4. Doctors evaluate patients who are not suitable for inclusion.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henan Cancer Hospital Zhengzhou Henan China 450008

Sponsors and Collaborators

  • SuxiaLuo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SuxiaLuo, chief physician, Henan Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05130424
Other Study ID Numbers:
  • HNHQRWS
First Posted:
Nov 23, 2021
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021