Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A

NCT02888223 | Unknown Phase 1

• 1 other identifier: SCT800HA1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (4)

• Incremental Recovery (K-value)

  One-stage aPTT Assay

  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

  48 hours after the end of the infusion

• Elimination Phase Half-life (t1/2)

  One-stage aPTT Assay

  48 hours after the end of the infusion

• Factor VIII (FVIII) Clearance (CL)

  One-stage aPTT Assay

  48 hours after the end of the infusion

Secondary Outcomes (6)

• Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC∞)

  48 hours after the end of the infusion

• FVIII Maximum Plasma Concentration (Cmax)

  3 hours after the end of the infusion

• Mean Residence Time (MRT)

  48 hours after the end of the infusion

• Volume of Distribution at Steady State (Vss)

  48 hours after the end of the infusion

• Incidence of inhibitors

  72 hours after the end of the infusion

Study Arms (2)

Group A

EXPERIMENTAL

a single dose administration of SCT800 followed by Xyntha (50 IU.kg-1, based upon the manufacturer's labeled potency)

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)

Biological: SCT800; Biological: Xyntha

Interventions

SCT800 BIOLOGICAL

Also known as: Recombinant human coagulation factor VIII

Group A; Group B

Xyntha BIOLOGICAL

Also known as: Antihemophilic Factor (Recombinant), Plasma/Albumin-Free

Group A; Group B

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Xiangya Hospital of Centre-South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, human; Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Xie lan Zhao, PhD

  Xiangya Hospital of Centre-South University, Changsha, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 2, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 2, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)