Hemophilia APhase 1NCT02888223
Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A
A Phase 1 study testing SCT800 and Xyntha in people with Hemophilia A, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). 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?
- SCT800 and Xyntha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Jul 2017
- 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
- 12 to 65 years old;
- The activity of the coagulation factor VIII (FVIII:C) ≤2%, and was previously treated with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
- Non-bleeding state (No clinical manifestations of active hemorrhage);
- Negative assays for FVIII inhibitors (<0.6 BU/mL);
- The platelet count is normal；
- Normal prothrombin time or INR ≤1.5；
- Given informed consent
Who cannot join
- Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
- Family history or history of FVIII inhibitors (≥0.6 Bethesda Units [BU] mL-1);
- Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days prior to study entry (including rFVIII, plasma-derived factor VIII [pdFVIII], cryoprecipitate and whole blood);
- Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
- HIV seropositive;
- Abnormal hemostasis from causes other than hemophilia A；
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- Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level);
- Patients who received any anticoagulant or antiplatelet therapy within one week (including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials;
- Alcoholism, drug abuse, mental disorders and mental retardation;
- Elective surgery planned during the process of study;
- Patients who previously participated in the other clinical trials prior to study entry;
- The patient or parent/legal guardian is unable or unwilling to sign an informed consent form or to comply with the requirements of clinical protocol;
- Other conditions confirmed by the researchers, resulting in that patients are unable to benefit from clinical observation;
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Centre-South University
Changsha, Hunan, 410008
Peijun Xiao, 86-731-84327919, cancergcp@163.com
About this study
Official title: Pharmacokinetic Comparison of SCT800 (B-domain Deleted Recombinant Factor VIII) With Xyntha in Previously Treated Patients With Hemophilia A: a Phase I, Open-label, Randomized, Crossover Study
Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).
- Conditions
- Hemophilia A
- Being tested
- SCT800, Xyntha
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT800Biological
Also called Recombinant human coagulation factor VIII
XynthaBiological
Also called Antihemophilic Factor (Recombinant), Plasma/Albumin-Free
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | a single dose administration of SCT800 followed by Xyntha (50 IU.kg-1, based upon the manufacturer's labeled potency) Receives: Biological: SCT800; Biological: Xyntha |
| Group B | Experimental | a single dose administration of Xyntha followed by SCT800(50 IU.kg-1, based upon the manufacturer's labeled potency) Receives: Biological: SCT800; Biological: Xyntha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Recovery (K-value)
One-stage aPTT Assay
Measured: 1hour after the end of the infusion
Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUClast)
One-stage aPTT Assay
Measured: 48 hours after the end of the infusion
Elimination Phase Half-life (t1/2)
One-stage aPTT Assay
Measured: 48 hours after the end of the infusion
Factor VIII (FVIII) Clearance (CL)
One-stage aPTT Assay
Measured: 48 hours after the end of the infusion
Secondary outcomes (6)
Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC∞)
One-stage aPTT Assay
Measured: 48 hours after the end of the infusion
FVIII Maximum Plasma Concentration (Cmax)
One-stage aPTT Assay
Measured: 3 hours after the end of the infusion
Mean Residence Time (MRT)
One-stage aPTT Assay
Measured: 48 hours after the end of the infusion
Volume of Distribution at Steady State (Vss)
One-stage aPTT Assay
Measured: 48 hours after the end of the infusion
Incidence of inhibitors
Measured: 72 hours after the end of the infusion
AEs related to SCT800 during treatment and observation of the clinical study
Measured: 48 hours after the end of the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017 (estimated)
- Study completionJul 2017 (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 Sinocelltech 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xie lan Zhao, PhD, Principal investigator, Xiangya Hospital of Centre-South University, Changsha, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888223
- Sponsor's protocol ID
- SCT800HA1
- Status last verified
- Aug 2016
- First submitted
- 30 Aug 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Comparison of SCT800 (B-domain Deleted Recombinant Factor VIII) With Xyntha in Previously Treated Patients With Hemophilia A: a Phase I, Open-label, Randomized, Crossover Study
- ClinicalTrials.gov ID
- NCT02888223
- Acronym / sponsor ID
- SCT800HA1
- Conditions
- Hemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 2 Sep 2016 (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.
Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: SCT800, Biological: Xynthaa single dose administration of SCT800 followed by Xyntha (50 IU.kg-1, based upon the manufacturer's labeled potency) |
| Group B | Experimental | Biological: SCT800, Biological: Xynthaa single dose administration of Xyntha followed by SCT800(50 IU.kg-1, based upon the manufacturer's labeled potency) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 12 to 65 years old;
- The activity of the coagulation factor VIII (FVIII:C) ≤2%, and was previously treated with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
- Non-bleeding state (No clinical manifestations of active hemorrhage);
- Negative assays for FVIII inhibitors (<0.6 BU/mL);
- The platelet count is normal；
Key exclusion criteria (13 listed)
- Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
- Family history or history of FVIII inhibitors (≥0.6 Bethesda Units [BU] mL-1);
- Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days prior to study entry (including rFVIII, plasma-derived factor VIII [pdFVIII], cryoprecipitate and whole blood);
- Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
- HIV seropositive;
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 |
|---|---|---|
| SCT800Also: Recombinant human coagulation factor VIII | Biological | Group A, Group B |
| XynthaAlso: Antihemophilic Factor (Recombinant), Plasma/Albumin-Free | Biological | Group A, Group B |
Primary outcome
Incremental Recovery (K-value)
Time frame: 1hour after the end of the infusion
One-stage aPTT Assay
Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUClast)
Time frame: 48 hours after the end of the infusion
One-stage aPTT Assay
Elimination Phase Half-life (t1/2)
Time frame: 48 hours after the end of the infusion
One-stage aPTT Assay
Factor VIII (FVIII) Clearance (CL)
Time frame: 48 hours after the end of the infusion
One-stage aPTT Assay
6 secondary outcomes
Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC∞)
Time frame: 48 hours after the end of the infusion
FVIII Maximum Plasma Concentration (Cmax)
Time frame: 3 hours after the end of the infusion
Mean Residence Time (MRT)
Time frame: 48 hours after the end of the infusion
Volume of Distribution at Steady State (Vss)
Time frame: 48 hours after the end of the infusion
Incidence of inhibitors
Time frame: 72 hours after the end of the infusion
AEs related to SCT800 during treatment and observation of the clinical study
Time frame: 48 hours after the end of the infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- 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.
Xie lan Zhao, PhD principal investigator
Xiangya Hospital of Centre-South University, Changsha, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCT800 and Xyntha in people with Hemophilia A, run by Sinocelltech Ltd. 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 13 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 2 Sep 2016. 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Recovery (K-value) (time frame: 1hour after the end of the infusion). The study lists 4 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 2 Sep 2016.