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

November 18, 2021 updated by: SuxiaLuo
To observe and evaluate the safety and effectiveness of herombopag in the treatment of thrombocytopenia-related diseases in Henan Province

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

498

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with thrombocytopenia-related diseases

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events after the treatment of Herombopag
Time Frame: 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.
From the treatment of Herombopag to 28 days after the end of the medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the platelet counts after the treatment of Herombopag
Time Frame: 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。
From the treatment of Herombopag to 28 days after the end of the medication
Proportion of patients with platelet transfusion
Time Frame: 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。
From the treatment of Herombopag to 28 days after the end of the medication

Collaborators and Investigators

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

Sponsor

SuxiaLuo

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 (Actual)

September 29, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNHQRWS

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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