Pharmacokinetics Evaluation of Recombinant Coagulation Factor VIII Injection in Subjects With Hemophilia A.

NCT04060836 | Unknown Phase 1

• 1 other identifier: CTTQ-NXBYZ-02-PK
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multi-center, open-label, randomized study. Participants will be assigned to A or B groups with a scale of 1:1 , i.e. infuse study drug followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the study will enter the Prophylactic Therapy Study.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameters between test preparation and reference preparation, peak plasma concentration (Cmax)

  Cmax is the maximum plasma concentration of Recombinant Coagulation Factor VIII or metabolite(s).

  Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

• Pharmacokinetic parameters between Recombinant Coagulation Factor VIII, Area under the plasma concentration verus time curve(AUC)

  To characterize the pharmacokinetics of Recombinant Coagulation Factor VIII by assessment of area under the plasma concentration time curve from zero to infinity.

  Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

• Incremental recovery between test preparation and reference preparation

  Peak activity of FVIII (as Cmax) measured within 1 hour after the end of infusion.

  up to 24 weeks

Secondary Outcomes (13)

• tmax

  Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

• t1/2

  Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on multiple dose in day 5 to day 8.

• Mean time of residence (MRT)

  Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

• λz

  Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

• CL

  Hour 30min (pre-dose), 5min, 20min, 35min, 60min, 1.5 h, 2h, 3 h, 6 h, 9 h, 24 h, 36 h, 48 h post-dose on single dose in day 1 to day 4.

Study Arms (2)

group A

EXPERIMENTAL

Participants will be assigned to group A or B with a scale of 1:1 , i.e. infuse reference drug Xyntha (group A), then experimental drug (group B). All participants who completed the study will enter the prophylaxis group study.

Drug: Xyntha; Drug: Recombinant Coagulation Factor VIII Injection

group B

EXPERIMENTAL

Participants will be assigned to group A or B with a scale of 1:1 , i.e. infuse experimental drug (group B), then reference drug Xyntha (group A). All participants who completed the study will enter the prophylaxis group study.

Drug: Xyntha; Drug: Recombinant Coagulation Factor VIII Injection

Interventions

Xyntha DRUG

Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.

group A; group B

Recombinant Coagulation Factor VIII Injection DRUG

A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.

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:

• Hemophilia A.
• FVIII:C \<1%. 3）12 and 65 years old.
• ）Has received FVIII treatment and the treatment exposure days ≥100. 5）Has bleeding treatment records of at least 3 months before randomization. 6）FVIII inhibitor assay results is negative.
• ） Subjects should agree to use an adequate method of contraception during the study.
• ）Understood and Signed an informed consent form. 9）Has not received an treatment of any FVIII within 4 days before the first dose.
• ）Non-bleeding state.

You may not qualify if:

• Has a history or family history of blood coagulation factor VIII inhibitor.
• Has other coagulation dysfunction diseases in addition to hemophilia A.
• HIV positive.
• Plan to receive surgery during the trial.
• Has used immunomodulator within one weeks before the first dose，and less than 7 half-life periods.
• Known to be allergic to experimental drugs or any excipients.
• Severe anemia and need blood transfusion.
• Serious liver or kidney damage.
• Serious heart disease.
• Uncontrollable hypertension.
• Has participated in other clinical studies within one month before the first dose.
• The researchers believe that it is not suitable for participants.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (5)

AnHui Provincial Hospital

Hefei, Anhui, 230001, China

RECRUITING

The First Hospital of LanZhou University

Lanzhou, Gansu, 730000, China

RECRUITING

HeNan Cancer Provincial Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, 410013, China

RECRUITING

Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, human

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

Central Study Contacts

Lei Zhang, Doctor

CONTACT

022-20909240; zhanglei1@ihcams.ac.cn

Study Design

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

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: August 19, 2019
• Study Start: May 8, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

CN (5)