Hemophilia APhase 1NCT04060836
Pharmacokinetics Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.
A Phase 1 study testing Xyntha and Recombinant Coagulation Factor VIII Injection in people with Hemophilia A, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.
Trial summary
This is a multi-center, open-label, randomized study. Participants will be assigned to A or B groups with a scale of 1:1 , i.e. infuse study drug followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the study will enter the Prophylactic Therapy Study. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Xyntha and Recombinant Coagulation Factor VIII Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesChina
- Study dates
- 8 May 2019to Mar 2020
- Phase
- Phase 1
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hemophilia A.
- FVIII:C <1%. 3）12 and 65 years old.
- 4）Has received FVIII treatment and the treatment exposure days ≥100. 5）Has bleeding treatment records of at least 3 months before randomization. 6）FVIII inhibitor assay results is negative.
- 7） Subjects should agree to use an adequate method of contraception during the study.
- 8）Understood and Signed an informed consent form. 9）Has not received an treatment of any FVIII within 4 days before the first dose.
- 10）Non-bleeding state.
Who cannot join
- Has a history or family history of blood coagulation factor VIII inhibitor.
- Has other coagulation dysfunction diseases in addition to hemophilia A.
- HIV positive.
- Plan to receive surgery during the trial.
- Has used immunomodulator within one weeks before the first dose，and less than 7 half-life periods.
- Known to be allergic to experimental drugs or any excipients.
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- Severe anemia and need blood transfusion.
- Serious liver or kidney damage.
- Serious heart disease.
- Uncontrollable hypertension.
- Has participated in other clinical studies within one month before the first dose.
- The researchers believe that it is not suitable for participants.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410013
Xielan Zhao, Doctor, 0731-84327564, zhaoxl9198@163.com
Xielan Zhao
- Recruiting
AnHui Provincial Hospital
Hefei, Anhui, 230001
Zimin Sun, Doctor, 0551 -62283191, zmsun_vip@163.com
Zimin Sun
- Recruiting
The First Hospital of LanZhou University
Lanzhou, Gansu, 730000
Yaming Xi, Doctor, 0931-8356266, xiyaming@163.com
Yaming Xi
- Recruiting
Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Lei Zhang, Doctor, 022-20909240, zhanglei1@ihcams.ac.cn
Lei Zhang
- Recruiting
HeNan Cancer Provincial Hospital
Zhengzhou, Henan, 450008
Hu Zhou, Doctor, 0371-65587278, "papertigerhu@163.com
Hu Zhou
About this study
Official title: Randomized, Open-label, Double Cycle, Crossover, Pharmacokinetics Study of Recombinant Coagulation Factor VIII Injection Versus Xyntha® in Subjects With Hemophilia A.
This is a multi-center, open-label, randomized study. Participants will be assigned to A or B groups with a scale of 1:1 , i.e. infuse study drug followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the study will enter the Prophylactic Therapy Study.
- Conditions
- Hemophilia A
- Being tested
- Xyntha, Recombinant Coagulation Factor VIII Injection
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XynthaDrug
Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.
Recombinant Coagulation Factor VIII InjectionDrug
A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Participants will be assigned to group A or B with a scale of 1:1 , i.e. infuse reference drug Xyntha (group A), then experimental drug (group B). All participants who completed the study will enter the prophylaxis group study. Receives: Drug: Xyntha; Drug: Recombinant Coagulation Factor VIII Injection |
| group B | Experimental | Participants will be assigned to group A or B with a scale of 1:1 , i.e. infuse experimental drug (group B), then reference drug Xyntha (group A). All participants who completed the study will enter the prophylaxis group study. Receives: Drug: Xyntha; Drug: Recombinant Coagulation Factor VIII Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax)
Cmax is the maximum plasma concentration of Recombinant Coagulation Factor VIII or metabolite(s).
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
Pharmacokinetic parameters between Recombinant Coagulation Factor VIII, Area under the plasma concentration verus time curve(AUC)
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
Incremental recovery between test preparation and reference preparation
Peak activity of FVIII (as Cmax) measured within 1 hour after the end of infusion.
Measured: up to 24 weeks
Secondary outcomes (13)
tmax
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of time to reach maximum plasma concentration
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
t1/2
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of half-life
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.
Mean time of residence (MRT)
MRT is the average time that drug molecules stay in the body after a quick intravenous injection.
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
λz
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of terminal rate constant.
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
CL
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent plasma clearance following intravenous injection.
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
Vz
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent volume of distribution.
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
Area under the plasma concentration verus time curve (AUC)
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.
Peak plasma concentration (Cmax)
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of maximum plasma concentration.
Measured: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.
Recombinant Coagulation Factor VIII multiple dose:tmax
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of time to reach maximum plasma concentration.
Measured: On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:t1/2
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of half-life.
Measured: On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:λz
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of terminal rate constant.
Measured: On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:CL
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent plasma clearance following intravenous injection.
Measured: On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:Vz
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of apparent volume of distribution.
Measured: On the 176th day after the prevention of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start8 May 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
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 Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060836
- Sponsor's protocol ID
- CTTQ-NXBYZ-02-PK
- Status last verified
- Aug 2019
- First submitted
- 16 Jul 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Double Cycle, Crossover, Pharmacokinetics Study of Recombinant Coagulation Factor VIII Injection Versus Xyntha® in Subjects With Hemophilia A.
- ClinicalTrials.gov ID
- NCT04060836
- Acronym / sponsor ID
- CTTQ-NXBYZ-02-PK
- Conditions
- Hemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 19 Aug 2019 (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 a multi-center, open-label, randomized study. Participants will be assigned to A or B groups with a scale of 1:1 , i.e. infuse study drug followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the study will enter the Prophylactic Therapy Study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: Xyntha, Drug: Recombinant Coagulation Factor VIII InjectionParticipants will be assigned to group A or B with a scale of 1:1 , i.e. infuse reference drug Xyntha (group A), then experimental drug (group B). All participants who completed the study will enter the prophylaxis group study. |
| group B | Experimental | Drug: Xyntha, Drug: Recombinant Coagulation Factor VIII InjectionParticipants will be assigned to group A or B with a scale of 1:1 , i.e. infuse experimental drug (group B), then reference drug Xyntha (group A). All participants who completed the study will enter the prophylaxis group study. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Hemophilia A.
- FVIII:C <1%. 3）12 and 65 years old.
- 4）Has received FVIII treatment and the treatment exposure days ≥100. 5）Has bleeding treatment records of at least 3 months before randomization. 6）FVIII inhibitor assay results is negative.
- 7） Subjects should agree to use an adequate method of contraception during the study.
- 8）Understood and Signed an informed consent form. 9）Has not received an treatment of any FVIII within 4 days before the first dose.
Key exclusion criteria (12 listed)
- Has a history or family history of blood coagulation factor VIII inhibitor.
- Has other coagulation dysfunction diseases in addition to hemophilia A.
- HIV positive.
- Plan to receive surgery during the trial.
- Has used immunomodulator within one weeks before the first dose，and less than 7 half-life periods.
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 |
|---|---|---|
| XynthaRecombinant Coagulation Factor VIII Injection produced by Pfizer Inc. | Drug | group A, group B |
| Recombinant Coagulation Factor VIII InjectionA kind of Recombinant Coagulation Factor VIII Injection produced by sponsor. | Drug | group A, group B |
Primary outcome
Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax)
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
Cmax is the maximum plasma concentration of Recombinant Coagulation Factor VIII or metabolite(s).
Pharmacokinetic parameters between Recombinant Coagulation Factor VIII, Area under the plasma concentration verus time curve(AUC)
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of area under the plasma concentration time curve from zero to infinity.
Incremental recovery between test preparation and reference preparation
Time frame: up to 24 weeks
Peak activity of FVIII (as Cmax) measured within 1 hour after the end of infusion.
13 secondary outcomes
tmax
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
t1/2
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.
Mean time of residence (MRT)
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
λz
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
CL
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
Vz
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.
Area under the plasma concentration verus time curve (AUC)
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.
Peak plasma concentration (Cmax)
Time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.
Recombinant Coagulation Factor VIII multiple dose:tmax
Time frame: On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:t1/2
Time frame: On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:λz
Time frame: On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:CL
Time frame: On the 176th day after the prevention of medication
Recombinant Coagulation Factor VIII multiple dose:Vz
Time frame: On the 176th day after the prevention of medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xyntha and Recombinant Coagulation Factor VIII Injection in people with Hemophilia A, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites 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 6 inclusion and 12 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 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Lei Zhang, Doctor (022-20909240, zhanglei1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax) (time frame: Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.). 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?
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 19 Aug 2019.