NCT00245297

Brief Summary

Primary efficacy endpoint: To study whether there is a difference in the length of the bleeding free periods between infusion of FVIII that is reconstituted with 22.1, 12.6, or 4.2 mg of pegylated liposomes per kg bwt compared with standard formulation. Safety endpoint: To study the safety and tolerability of Kogenate FS reconstituted with Pegylated liposomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

October 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

October 16, 2007

Status Verified

October 1, 2007

First QC Date

October 26, 2005

Last Update Submit

October 15, 2007

Conditions

Haemophilia A

Keywords

Bleeding disordersevere Haemophilia AProphylaxis

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy parameter is the number of bleeding free days (without a bleeding/treatment) between a randomized prophylactic infusion and following on demand injection.

    Bleeding free time following four single doses will be studies

Secondary Outcomes (1)

  • In vivo recovery (IVR).

    IVR will be performed at the first and last dose.

Interventions

Kogenate FS, reconstituted in a suspension of liposomesDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 60 years of age
  • Severe haemophilia A (≤ 1% of baseline Factor VIII activity)
  • At least 250 treatment cumulative exposure-days (CEDs) to previous products
  • At least 25 cumulative exposure-days (CEDs) to previous products during one year prior to study start
  • If HIV positive, CD4 lymphocytes ≥ 400/µl
  • Subjects on demand treatment, and with a minimum bleeding/treatment pattern of a four episodes per month, evenly distributed within each month, during the three month preceding study start
  • Subjects who have given their written informed consent.

You may not qualify if:

  • Inhibitors or history of inhibitors
  • History of adverse reactions related to Factor VIII
  • Platelet count \<90,000 /µl
  • Subjects on prophylaxis treatment
  • Subjects with concomitant debilitating disease (e.g. cancer, non-controlled diabetes, heart insufficiency, renal failure)
  • Subjects with known sensitivity to blood products
  • Subjects who have participated in another Ethical Committee approved Clinical Trial (including medical device studies) within the past 30 days
  • Subjects with a weight over 86 kg or below 50 kg
  • Subjects who do not understand or are not willing to comply with the requirement of the study protocol
  • Subjects who cannot differentiate a bleeding episode from other causes of joint pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Center for Hematological Research, Department of Reconstructive Orthopedic Surgery

Moscow, 125167, Russia

Location

The Russian Academy of Medical Sciences, Haemophilia Center

Moscow, 125167, Russia

Location

Republic Haemophilia Center.

Saint Petersburg, 191186, Russia

Location

Related Publications (1)

  • Baru M, Carmel-Goren L, Barenholz Y, Dayan I, Ostropolets S, Slepoy I, Gvirtzer N, Fukson V, Spira J. Factor VIII efficient and specific non-covalent binding to PEGylated liposomes enables prolongation of its circulation time and haemostatic efficacy. Thromb Haemost. 2005 Jun;93(6):1061-8. doi: 10.1160/TH04-08-0485.

    PMID: 15968389BACKGROUND

MeSH Terms

Conditions

Hemophilia AHemostatic Disorders

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 AbnormalitiesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jack Spira, MD. PhD.

    Recoly C/o InSpira Medical AB, Nasbyv 38, 13553 Tyreso Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 27, 2005

Study Start

October 1, 2005

Study Completion

April 1, 2006

Last Updated

October 16, 2007

Record last verified: 2007-10

Locations

RU(3)