Hemophilia ANCT07101224
Data Registry in Chinese Hemophilia A and B Patients
An observational study of Hemophilia A and Hemophilia B, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is an open-label, prospective, multi-center, patient registry in Chinese Hemophilia A and B patients treated with anti-hemophilic coagulation factor replacement therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A, Hemophilia B
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2017to 30 Jun 2019
- How long will I take part?
- 2 Years
- 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: Diagnosed Hemophilia A and Hemophilia B patient with anti-hemophilic coagulation factor replacement therapy will be selected.
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Hemophilia A and Hemophilia B patient diagnosed;
- Taking anti-hemophilic coagulation factor replacement therapy during the 2 year registry period.
Who cannot join
- 1. Unwilling or unable to follow the terms of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Data Registry in Chinese Hemophilia A and B Patients Related to the Use of Anti-hemophilic Coagulation Factor Replacement Therapy
This is an open-label, prospective, multi-center, patient registry in Chinese Hemophilia A and B patients treated with anti-hemophilic coagulation factor replacement therapy.
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- anti-hemophilic coagulation factor replacement therapy
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia A | Not described | |
| Hemophilia B | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of MIEs and other SAEs
The incidence of MIE(medically important events)s and other SAE(serious adverse event)s in the anti-hemophilic replacement treatment
Measured: at the end of 2 year data registry
Secondary outcomes (1)
Treatment regimen
Treatment regimen of anti-hemophilic replacement treatment
Measured: at the end of 2 year data registry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start7 May 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101224
- Sponsor's protocol ID
- QT2016004
- Status last verified
- May 2024
- First submitted
- 26 May 2017
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Registry in Chinese Hemophilia A and B Patients Related to the Use of Anti-hemophilic Coagulation Factor Replacement Therapy
- ClinicalTrials.gov ID
- NCT07101224
- Acronym / sponsor ID
- QT2016004
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- anti-hemophilic coagulation factor replacement therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 7 May 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 3 Aug 2025 (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.
This is an open-label, prospective, multi-center, patient registry in Chinese Hemophilia A and B patients treated with anti-hemophilic coagulation factor replacement therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemophilia A | – | – |
| Hemophilia B | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosed Hemophilia A and Hemophilia B patient with anti-hemophilic coagulation factor replacement therapy will be selected.
Key inclusion criteria (3 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Hemophilia A and Hemophilia B patient diagnosed;
- Taking anti-hemophilic coagulation factor replacement therapy during the 2 year registry period.
Key exclusion criteria (1 listed)
- 1. Unwilling or unable to follow the terms of the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of MIEs and other SAEs
Time frame: at the end of 2 year data registry
The incidence of MIE(medically important events)s and other SAE(serious adverse event)s in the anti-hemophilic replacement treatment
1 secondary outcome
Treatment regimen
Time frame: at the end of 2 year data registry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemophilia A and Hemophilia B, run by Institute of Hematology & Blood Diseases Hospital, China 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 1 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: finished, as of the sponsor's last update on 3 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of MIEs and other SAEs (time frame: at the end of 2 year data registry). 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 3 Aug 2025.