Hemophilia AReCARENCT02263066
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
An observational study of Hemophilia A, run by Bayer at 1 site in China.
Trial summary
To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013) Read more about this study
- Who is it for?
- Ages 2 to 18 years, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- BAY14-2222_Kogenate-FS FVIII
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jul 2015
- 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 2 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: About 300 at most hemophilia boys (2-<18 years) in the representative hemophilia treatment centers (HTCs) with available medical data record, having received rFVIII contained regular prophylaxis between Nov. 1st 2007 and May 31st 2013 will be enrolled from about 15 centers.
Who may be able to join
- Male, 2-<18 years Hemophilia A, based on documented prior testing and/or screening laboratory Patients who had received regular prophylaxis/bleeding prevention treatment, totally/partially with rFⅧ. Regular prophylaxis/bleeding prevention treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment weeks≥80%[10] , and total duration ≥12 weeks. During the regular prophylaxis period, if there were consecutive 4 weeks that <2 infusion/week, the beginning day of the 4 weeks is defined as the end of regular prophylaxis.
- Available patient medical data record Written informed consent by parent/legal representative. Consent should be sought from subjects if appropriate
Who cannot join
- Patients with measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation (≥0.6BU by Bethesda assay at two different time points, documentation must be available) Any individuals with another bleeding disease that is different from hemophilia A (e.g, von Willebrand disease, hemophilia B)
Trial locations and contacts
1 site in 1 country.
About this study
To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)
- Conditions
- Hemophilia A
- Being tested
- BAY14-2222_Kogenate-FS FVIII
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY14-2222_Kogenate-FS FVIIIBiological
Depends on Doctor's decision
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Chinese hemophilia A pediatric patients with medical records who had accepted regular prophylaxis, totally/partially with rFⅧ between Nov. 1st 2007 and May 31st 2013 Receives: Biological: BAY14-2222_Kogenate-FS FVIII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of regular prophylaxis
Measured: Up to 1.5 years
Prophylaxis infusion dose
Measured: Up to 1.5 years
Percentage of rFVIII usage in prophylaxis
Measured: Up to 1.5 years
Secondary outcomes (4)
Bleeding frequency
Measured: Up to 1.5 years
Joint radiographic score
Measured: Up to 1.5 years
Joint physical examination score
Measured: Up to 1.5 years
Quality of life by questionnaire
Measured: Up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263066
- Sponsor's protocol ID
- 17653
- Acronym
- ReCARE
- Status last verified
- Jul 2015
- First submitted
- 8 Oct 2014
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Li C, Zhang X, Zhao Y, Wu R, Hu Q, Xu V, Sun J, Yang R, Li X, Zhou R, Lian S, Gu J, Wu J, Hou Q. Status and trend analysis of prophylactic usage of recombinant factor VIII in Chinese pediatric patients with hemophilia A: ReCare - a retrospective, phase IV, non-interventional study. Curr Med Res Opin. 2017 Sep;33(9):1571-1578. doi: 10.1080/03007995.2017.1333489. Epub 2017 Jun 21.
PubMed 28532239Li C, Zhang X, Zhao Y, Wu R, Hu Q, Xu W, Sun J, Yang R, Li X, Zhou R, Lian S, Gu J, Wu J, Hou Q. Long-term efficacy and safety of prophylaxis with recombinant factor VIII in Chinese pediatric patients with hemophilia A: a multi-center, retrospective, non-interventional, phase IV (ReCARE) study. Curr Med Res Opin. 2017 Jul;33(7):1223-1230. doi: 10.1080/03007995.2017.1310720. Epub 2017 Apr 25.
PubMed 28326849
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
- ClinicalTrials.gov ID
- NCT02263066
- Acronym / sponsor ID
- ReCARE / 17653
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Oct 2014 (estimated)
- 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 assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: BAY14-2222_Kogenate-FS FVIIIChinese hemophilia A pediatric patients with medical records who had accepted regular prophylaxis, totally/partially with rFⅧ between Nov. 1st 2007 and May 31st 2013 |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- About 300 at most hemophilia boys (2-<18 years) in the representative hemophilia treatment centers (HTCs) with available medical data record, having received rFVIII contained regular prophylaxis between Nov. 1st 2007 and May 31st 2013 will be enrolled from about 15 centers.
Key inclusion criteria (2 listed)
- Male, 2-<18 years Hemophilia A, based on documented prior testing and/or screening laboratory Patients who had received regular prophylaxis/bleeding prevention treatment, totally/partially with rFⅧ. Regular prophylaxis/bleeding prevention treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment weeks≥80%[10] , and total duration ≥12 weeks. During the regular prophylaxis period, if there were consecutive 4 weeks that <2 infusion/week, the beginning day of the 4 weeks is defined as the end of regular prophylaxis.
- Available patient medical data record Written informed consent by parent/legal representative. Consent should be sought from subjects if appropriate
Key exclusion criteria (1 listed)
- Patients with measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation (≥0.6BU by Bethesda assay at two different time points, documentation must be available) Any individuals with another bleeding disease that is different from hemophilia A (e.g, von Willebrand disease, hemophilia B)
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 |
|---|---|---|
| BAY14-2222_Kogenate-FS FVIIIDepends on Doctor's decision | Biological | Group 1 |
Primary outcome
Duration of regular prophylaxis
Time frame: Up to 1.5 years
Prophylaxis infusion dose
Time frame: Up to 1.5 years
Percentage of rFVIII usage in prophylaxis
Time frame: Up to 1.5 years
4 secondary outcomes
Bleeding frequency
Time frame: Up to 1.5 years
Joint radiographic score
Time frame: Up to 1.5 years
Joint physical examination score
Time frame: Up to 1.5 years
Quality of life by questionnaire
Time frame: Up to 1.5 years
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 17 Jul 2015.
- Derived from this study: PubMed 28532239Li C, Zhang X, Zhao Y, Wu R, Hu Q, Xu V, Sun J, Yang R, Li X, Zhou R, Lian S, Gu J, Wu J, Hou Q. Status and trend analysis of prophylactic usage of recombinant factor VIII in Chinese pediatric patients with hemophilia A: ReCare - a retrospective, phase IV, non-interventional study. Curr Med Res Opin. 2017 Sep;33(9):1571-1578. doi: 10.1080/03007995.2017.1333489. Epub 2017 Jun 21.
- Derived from this study: PubMed 28326849Li C, Zhang X, Zhao Y, Wu R, Hu Q, Xu W, Sun J, Yang R, Li X, Zhou R, Lian S, Gu J, Wu J, Hou Q. Long-term efficacy and safety of prophylaxis with recombinant factor VIII in Chinese pediatric patients with hemophilia A: a multi-center, retrospective, non-interventional, phase IV (ReCARE) study. Curr Med Res Opin. 2017 Jul;33(7):1223-1230. doi: 10.1080/03007995.2017.1310720. Epub 2017 Apr 25.
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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.
Bayer Study Director study director
Bayer
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, run by Bayer 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 2 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 17 Jul 2015. 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?
Duration of regular prophylaxis (time frame: Up to 1.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263066, which also lists 2 linked publications.
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 17 Jul 2015.