Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02888223
• Other study ID #: SCT800HA1
• Status: Not yet recruiting
• Phase: Phase 1
• First received: August 30, 2016
• Last updated: August 30, 2016
• Start date: September 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: Sinocelltech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: July 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Biological:
• SCT800

• Xyntha

Locations

Country	Name	City	State
China	Xiangya Hospital of Centre-South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Recovery (K-value)	One-stage aPTT Assay	1hour after the end of the infusion	No
Primary	Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUClast)	One-stage aPTT Assay	48 hours after the end of the infusion	No
Primary	Elimination Phase Half-life (t1/2)	One-stage aPTT Assay	48 hours after the end of the infusion	No
Primary	Factor VIII (FVIII) Clearance (CL)	One-stage aPTT Assay	48 hours after the end of the infusion	No
Secondary	Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC8)	One-stage aPTT Assay	48 hours after the end of the infusion	No
Secondary	FVIII Maximum Plasma Concentration (Cmax)	One-stage aPTT Assay	3 hours after the end of the infusion	No
Secondary	Mean Residence Time (MRT)	One-stage aPTT Assay	48 hours after the end of the infusion	No
Secondary	Volume of Distribution at Steady State (Vss)	One-stage aPTT Assay	48 hours after the end of the infusion	No
Secondary	Incidence of inhibitors		72 hours after the end of the infusion	Yes
Secondary	AEs related to SCT800 during treatment and observation of the clinical study		48 hours after the end of the infusion	Yes