Carcinoma;BloodNCT05130424
A Real-world Study of Herombopag in the Treatment of Thrombocytopenia Related Diseases in Henan Province
An observational study of Carcinoma;Blood, run by SuxiaLuo at 1 site in China.
Trial summary
To observe and evaluate the safety and effectiveness of herombopag in the treatment of thrombocytopenia-related diseases in Henan Province Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma;Blood
- What is being tested?
- Herombopag
- Type of treatment
- Pill or oral medicine
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2021to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with thrombocytopenia-related diseases
Who may be able to join
- Thrombocytopenia related diseases;
- Volunteer to join this study and sign an informed consent form;
- Clinical evaluation can benefit from Herombopag.
Who cannot join
- 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;
- Doctors evaluate patients who are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Suxia Luo, Doctor, 0371-65587697, 2290773710@qq.com
About this study
To observe and evaluate the safety and effectiveness of herombopag in the treatment of thrombocytopenia-related diseases in Henan Province
Read the 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.
- Conditions
- Carcinoma;Blood
- Being tested
- Herombopag
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The investigator will assess the changes of the platelet counts after the treatment of Herombopag。
Measured: From the treatment of Herombopag to 28 days after the end of the medication
Proportion of patients with platelet transfusion
The investigator will assess the proportion of patients with platelet transfusion after the treatment of Herombopag。
Measured: From the treatment of Herombopag to 28 days after the end of the medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start29 Sep 2021
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma;BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SuxiaLuo
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, SuxiaLuo, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130424
- Sponsor's protocol ID
- HNHQRWS
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Herombopag in the Treatment of Thrombocytopenia Related Diseases in Henan Province
- ClinicalTrials.gov ID
- NCT05130424
- Acronym / sponsor ID
- HNHQRWS
- Conditions
- Carcinoma;Blood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- SuxiaLuoOther government
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To observe and evaluate the safety and effectiveness of herombopag in the treatment of thrombocytopenia-related diseases in Henan Province
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with thrombocytopenia-related diseases
Key inclusion criteria (3 listed)
- Thrombocytopenia related diseases;
- Volunteer to join this study and sign an informed consent form;
- Clinical evaluation can benefit from Herombopag.
Key exclusion criteria (4 listed)
- 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;
- Doctors evaluate patients who are not suitable for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HerombopagHerombopag in the treatment of thrombocytopenia-related diseases Non-interventional clinical research.Do not interfere with the dosage and market of Hetrobopar Oral medication | Drug | – |
Primary outcome
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.
2 secondary outcomes
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
Proportion of patients with platelet transfusion
Time frame: From the treatment of Herombopag to 28 days after the end of the medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma;Blood, run by SuxiaLuo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact suxia luo (18638553211, luosxrm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.