Condition category
Haematological Disorders
Date applied
01/09/2008
Date assigned
04/09/2008
Last edited
04/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Martina Jansen

ORCID ID

Contact details

Oberlaaerstrasse 235
Vienna
1100
Austria
+43 (0)1 61032 1208
martina.jansen@octapharma.com

Additional identifiers

EudraCT number

2008-001910-25

ClinicalTrials.gov number

Protocol/serial number

WIL-21

Study information

Scientific title

Acronym

Study hypothesis

Comparison of pharmacokinetics of Wilate® and Haemate® P in von Willebrand type 3 patients.

Ethics approval

Ethics approval received from:
1. Ethics Committee of SHAT "Joan Pavel" OOD hospital, Sofia on the 15th July 2008
2. Ethics Committee of FNsP Cyril and Method Hospital, Bratislava on the 24th June 2008

Study design

Prospective, randomised, controlled, open-labelled, two-arm cross-over, multi-centre phase II study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request patient information material

Condition

von Willebrand disease

Intervention

1. Wilate® vials of approximately 400 IU VWF:RCo
2. Haemate® P vials of approximately 500 VWF:RCo

One vial of freeze-dried concentrate is reconstituted in 0.1% polysorbate 80 solution/water for injection. A dose of at least 40 IU VWF:RCo/kg body weight will be given intravenously by bolus administration. Each product is administered once. Blood samples will be taken at the following time-points after each infusion: 30 minutes before and at 15 minutes, 30 minutes, 45 minutes, 1, 3, 6, 12, 24, 30, 48, and 72 hours after the infusion.

Intervention type

Drug

Phase

Phase II

Drug names

Wilate®, Haemate® P

Primary outcome measures

The in-vivo half life (t1/2) of Wilate® is the primary endpoint and will be calculated for VWF ristocetin cofactor activity (VWF:RCo), FVIII:C, VWF antigen (VWF:Ag), and VWf collagen binding assay (VWF:CB).

Outcomes will be determined from plasma levels measured from samples taken at the above mentioned time-points.

Secondary outcome measures

1. Pharmacokinetics: the following parameters are secondary endpoints and will be calculated for VWF:RCo, FVIII:C, VWF:Ag and VWF:CB:
1.1. Area under the curve (AUC)
1.2. Maximum plasma concentration (Cmax)
1.3. Time to reach maximum plasma concentration (Tmax)
1.4. Mean residence time (MRT)
1.5. Volume of distribution (Vd)
1.6. Clearance (Cl)
For the calculation of these parameters, the labelled potency of the respective drug will be the taken. Outcomes will be determined from plasma levels measured from samples taken at the above mentioned time-points.
2. Recovery: in vivo incremental recovery of VWF:RCo, FVIII:C, VWF:Ag and VWF:CB will be calculated from the levels before and after the injection. For the calculation of recovery, the labelled potency of the respective drug will be the taken.
3. Tolerability: tolerability will be assessed by monitoring vital signs, haematological parameters (red blood cell [RBC] count, white blood cell [WBC] count, haemoglobin, haematocrit [HCT], and platelet count [PC]), and by monitoring adverse events (AEs)

Overall trial start date

01/09/2008

Overall trial end date

01/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Defined inherited von Willebrand disease (VWD) type 3
2. Male or female subject of at least 12 years of age and have a body weight of at least 32 kg but not more than 125 kg
3. Negative for hepatitis B surface antigen (HBsAg)
4. For human immunodeficiency virus (HIV)-positive subjects: must have a baseline CD4+ cell count of greater than 200/mm^3, and a platelet count of greater than 100,000/dL
5. Freely given written informed consent. For subjects who are not legally permitted to provide written consent, the consent must be provided by parents or legal guardians.
6. Females must promise to avoid becoming pregnant for visits 1 to 11

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

6

Participant exclusion criteria

1. Subjects with any other bleeding disorders
2. Known history of intolerance to plasma derivatives or blood products
3. Present or past inhibitor activity directed against any von Willebrand factor (VWF)/coagulation factor eight (FVIII) component
4. Severe liver or kidney disease
5. Participation in another clinical study involving an investigational treatment, either currently or within the 4 weeks prior to study entry. Studies consisting of data and blood sampling collections on a regular or long-term basis are exempt from this exclusion.
6. Subjects with excessive alcohol or illicit drug usage
7. Subjects who cannot comply with protocol requirements
8. Pregnant or lactating women

Recruitment start date

01/09/2008

Recruitment end date

01/11/2008

Locations

Countries of recruitment

Bulgaria, Slovakia

Trial participating centre

Oberlaaerstrasse 235
Vienna
1100
Austria

Sponsor information

Organisation

Octapharma AG (Switzerland)

Sponsor details

Seidenstrasse 2
Lachen
8853
Switzerland
+41 (0)55 4512121
olaf.walter@octapharma.ch

Sponsor type

Industry

Website

http://www.octapharma.com

Funders

Funder type

Industry

Funder name

Octapharma AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes