Brief Title
Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A
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
Brief 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). All participants who completed the SCT800HA1 study will
enter the efficacy and safety study (Protocol No.: SCT800HA3).
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incremental Recovery (K-value)
Secondary Outcome
Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC∞)
Condition
Hemophilia A
Intervention
SCT800
Study Arms / Comparison Groups
Group A
Description: a single dose administration of SCT800 followed by Xyntha (50 IU.kg-1, based upon the manufacturer's labeled potency)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
16
Start Date
September 2016
Completion Date
July 2017
Primary Completion Date
February 2017
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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；
- 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;
Gender
All
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Xie lan Zhao, PhD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02888223
Organization ID
SCT800HA1
Responsible Party
Sponsor
Study Sponsor
Sinocelltech Ltd.
Study Sponsor
Xie lan Zhao, PhD, Principal Investigator, Xiangya Hospital of Centre-South University, Changsha, China
Verification Date
August 2016