PharmacokineticsPhase 4PKNCT03622476
Pharmacokinetic (PK)Research on Chinese Children of Hemophilia
A Phase 4 study testing concentrated FVIII in people with Pharmacokinetics, run by Beijing Children's Hospital at 1 site in China.
Trial summary
The study start on June 30, 2018. The Severe(F Ⅷ<1%) hemophilia A children without F Ⅷ inhibitor combining were recruited to Test the concentration of the drug in the blood to provide better treatment. Read more about this study
- Who is it for?
- Ages 1 year to 14 years, men only
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- concentrated FVIII
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2018to 30 Aug 2021
- Phase
- Phase 4
- 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 1 year to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- FⅧ<1% ,
- 1-14years old,
- There have been at least one history of bleeding in any joint of the knee, elbow, or ankle.
- A blood product containing FVIII is applied.
- There were no inhibitors at the time of enrollment, and there was no inhibitor-positive history and family history.
- Clinical visits are available on a regular basis and data is available, and preventive treatment is available prior to enrollment.
- The child was enrolled in the group and the guardian agreed.
Who cannot join
- Combining other disease researchers believes that it is not suitable for enrollment.
- FVIII inhibitor was found.
- Refuse to participate in research
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital
Beijing, Beijing Municipality, 100045
chen zhenping, Ph.D
About this study
Official title: Capital Characteristic Application: Pharmacokinetic（PK） Research on Chinese Children of Hemophilia
The study start on June 30, 2018. The Severe(F Ⅷ<1%) hemophilia A children without F Ⅷ inhibitor combining were recruited to Test the concentration of the drug in the blood to provide better treatment.
Read the detailed description
Through the integration of two technologies, pharmacokinetics and comprehensive evaluation system, we can improve the individualized prevention and treatment of hemophilia in Chinese children and achieve precise customization of treatment plans. Rational use of medical resources, but also fully achieve the prevention and treatment goals.
- Conditions
- Pharmacokinetics
- Being tested
- concentrated FVIII
- Keywords
- Hemophilia A，pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentrated FVIIIDrug
Intervention if the assessment considers that the treatment is inadequate
| Study group | Role | What they receive |
|---|---|---|
| PK research | Experimental | Interventional studies were performed in the 1-7 year old subgroup, and the children received a comprehensive assessment and PK test every 3 months. After the 72-hour washout period, 50 IU/kg of concentrated FVIII was administered in a single dose, and blood was taken within half an hour before the infusion and 1 h, 9 h, 24 h, and 48 h after the infusion, and the samples were centrifuged. If the assessment considers that the treatment is inadequate, then the valley concentration target is upgraded. Receives: Drug: concentrated FVIII |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound evaluation
the sonographer will use ultrasound to assess whether the patient's joint lesions become more severe than when they were enrolled.
Measured: 3 years
Imaging evaluation
the imaging specialist will use MRI to assess whether the patient's joint lesions are more severe than when they were enrolled.
Measured: 3 years
Secondary outcomes (2)
Annualized Bleeding Rate
How many times for all types of bleeding
Measured: 3 years
Annualized Joint Bleeding Rate
How many times for joint bleeding
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start30 Jun 2018
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Runhui WU, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622476
- Sponsor's protocol ID
- BCH-PK-20180630
- Acronym
- PK
- Status last verified
- Aug 2018
- First submitted
- 30 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capital Characteristic Application: Pharmacokinetic（PK） Research on Chinese Children of Hemophilia
- ClinicalTrials.gov ID
- NCT03622476
- Acronym / sponsor ID
- PK / BCH-PK-20180630
- Conditions
- Pharmacokinetics
- Keywords
- Hemophilia A，pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 9 Aug 2018 (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.
The study start on June 30, 2018. The Severe(F Ⅷ<1%) hemophilia A children without F Ⅷ inhibitor combining were recruited to Test the concentration of the drug in the blood to provide better treatment.
Detailed description
Through the integration of two technologies, pharmacokinetics and comprehensive evaluation system, we can improve the individualized prevention and treatment of hemophilia in Chinese children and achieve precise customization of treatment plans. Rational use of medical resources, but also fully achieve the prevention and treatment goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PK research | Experimental | Drug: concentrated FVIIIInterventional studies were performed in the 1-7 year old subgroup, and the children received a comprehensive assessment and PK test every 3 months. After the 72-hour washout period, 50 IU/kg of concentrated FVIII was administered in a single dose, and blood was taken within half an hour before the infusion and 1 h, 9 h, 24 h, and 48 h after the infusion, and the samples were centrifuged. If the assessment considers that the treatment is inadequate, then the valley concentration target is upgraded. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- FⅧ<1% ,
- 1-14years old,
- There have been at least one history of bleeding in any joint of the knee, elbow, or ankle.
- A blood product containing FVIII is applied.
- There were no inhibitors at the time of enrollment, and there was no inhibitor-positive history and family history.
Key exclusion criteria (3 listed)
- Combining other disease researchers believes that it is not suitable for enrollment.
- FVIII inhibitor was found.
- Refuse to participate in research
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 |
|---|---|---|
| concentrated FVIIIIntervention if the assessment considers that the treatment is inadequate | Drug | PK research |
Primary outcome
Ultrasound evaluation
Time frame: 3 years
the sonographer will use ultrasound to assess whether the patient's joint lesions become more severe than when they were enrolled.
Imaging evaluation
Time frame: 3 years
the imaging specialist will use MRI to assess whether the patient's joint lesions are more severe than when they were enrolled.
2 secondary outcomes
Annualized Bleeding Rate
Time frame: 3 years
Annualized Joint Bleeding Rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: No
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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?
A Phase 4 study testing concentrated FVIII in people with Pharmacokinetics, run by Beijing Children's Hospital 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 7 inclusion and 3 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 14 Aug 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 chen zhen ping, Ph.D (15011221677, chenzhenping@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound evaluation (time frame: 3 years). The study lists 2 primary outcomes in all. 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 14 Aug 2018.