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Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A

Primary Purpose

Hemophilia A

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SCT800

Xyntha

About this trial

This is an interventional treatment trial for Hemophilia A

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Xiangya Hospital of Centre-South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incremental Recovery (K-value)

One-stage aPTT Assay

Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUClast)

One-stage aPTT Assay

Elimination Phase Half-life (t1/2)

One-stage aPTT Assay

Factor VIII (FVIII) Clearance (CL)

One-stage aPTT Assay

Secondary Outcome Measures

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

One-stage aPTT Assay

FVIII Maximum Plasma Concentration (Cmax)

One-stage aPTT Assay

Mean Residence Time (MRT)

One-stage aPTT Assay

Volume of Distribution at Steady State (Vss)

One-stage aPTT Assay

Incidence of inhibitors

AEs related to SCT800 during treatment and observation of the clinical study

Full Information

NCT ID

NCT02888223

First Posted

August 30, 2016

Last Updated

August 30, 2016

Sponsor

Sinocelltech Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02888223

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

February 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinocelltech Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

SCT800

Other Intervention Name(s)

Recombinant human coagulation factor VIII

Intervention Type

Biological

Intervention Name(s)

Xyntha

Other Intervention Name(s)

Antihemophilic Factor (Recombinant), Plasma/Albumin-Free

Primary Outcome Measure Information:

Title

Incremental Recovery (K-value)

Description

One-stage aPTT Assay

Time Frame

1hour after the end of the infusion

Title

Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUClast)

Description

One-stage aPTT Assay

Time Frame

48 hours after the end of the infusion

Title

Elimination Phase Half-life (t1/2)

Description

One-stage aPTT Assay

Time Frame

48 hours after the end of the infusion

Title

Factor VIII (FVIII) Clearance (CL)

Description

One-stage aPTT Assay

Time Frame

48 hours after the end of the infusion

Secondary Outcome Measure Information:

Title

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

Description

One-stage aPTT Assay

Time Frame

48 hours after the end of the infusion

Title

FVIII Maximum Plasma Concentration (Cmax)

Description

One-stage aPTT Assay

Time Frame

3 hours after the end of the infusion

Title

Mean Residence Time (MRT)

Description

One-stage aPTT Assay

Time Frame

48 hours after the end of the infusion

Title

Volume of Distribution at Steady State (Vss)

Description

One-stage aPTT Assay

Time Frame

48 hours after the end of the infusion

Title

Incidence of inhibitors

Time Frame

72 hours after the end of the infusion

Title

AEs related to SCT800 during treatment and observation of the clinical study

Time Frame

48 hours after the end of the infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xie lan Zhao, PhD

Organizational Affiliation

Xiangya Hospital of Centre-South University, Changsha, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xiangya Hospital of Centre-South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peijun Xiao

Phone

86-731-84327919

cancergcp@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A

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