NCT00989196

Brief Summary

This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 17, 2014

Completed
Last Updated

October 8, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

September 30, 2009

Results QC Date

March 1, 2013

Last Update Submit

September 27, 2019

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (1)

  • The Area Under the Concentration Curve for Human-cl rhFVIII Compared to Kogenate FS

    After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.

    At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.

Secondary Outcomes (8)

  • Invivo Half-life (T1/2) for Human-cl rhFVIII Compared to Kogenate FS

    At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.

  • Maximum Plasma Concentration (Cmax) for Human-cl rhFVIII Compared to Kogenate FS

    At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.

  • Time to Reach Maximum Plasma Concentration (Tmax) for Human-cl rhFVIII Compared to Kogenate FS

    At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.

  • Mean Residence Time (MRT) for Human-cl rhFVIII Compared to Kogenate FS

    At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.

  • Volume of Distribution at Steady State (Vss) for Human-cl rhFVIII Compared to Kogenate FS

    At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.

  • +3 more secondary outcomes

Study Arms (2)

Human-cl rhFVIII

EXPERIMENTAL
Biological: Human-cl rhFVIII

Kogenate FS

ACTIVE COMPARATOR
Biological: Kogenate FS

Interventions

Human-cl rhFVIIIBIOLOGICAL

50 IU/kg for PK dose

Human-cl rhFVIII
Kogenate FSBIOLOGICAL

50 IU/kg for PK dose

Kogenate FS

Eligibility Criteria

Age12 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Severe hemophilia A (FVIII:C \<= 1%)
  • Male subjects between 12 and 65 years of age
  • Body weight 25 kg to 110 kg
  • Previously treated with FVIII concentrate for at least 150 EDs

You may not qualify if:

  • Other coagulation disorder than hemophilia A
  • Present or past FVIII inhibitor activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCLA Orthodpedic Hospital

Los Angeles, California, 90007, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

RUSH University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Medicine and Dentistry

New Brunswick, New Jersey, 08903, United States

Location

Prof. Lissitchkov

Sofia, Bulgaria

Location

Medizinische Hochschule

Hanover, Lower Saxony, Germany

Location

Vivantes Klinikum

Berlin, Germany

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, human

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Dr. Sigurd Knaub
Organization
Octapharma AG
sigurd.knaub@octapharma.com
+41 554512141

Study Officials

  • Sigurd Knaub, PhD

    Octapharma

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 2, 2009

Study Start

May 1, 2010

Primary Completion

October 1, 2011

Study Completion

September 1, 2012

Last Updated

October 8, 2019

Results First Posted

January 17, 2014

Record last verified: 2019-09

Locations

US(6)BU(1)DE(2)