Combination treatment with DDAVP and factor VIII clotting factor concentrates in patients with mild haemophilia A.

Phase 1

• Conditions: Mild hemophilia A patients with a FVIII plasma levels above 0.05 IU/mL.; MedDRA version: 18.1Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850; MedDRA version: 18.1Level: LLTClassification code 10060612Term: Hemophilia ASystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-005435-14-NL
• Lead Sponsor: Erasmus University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-10
• Last Update Posted: 30 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

-Mild hemophilia A patients (FVIII > 0.05 IU/mL)
-In need of surgery
-Age between 12 and 70 years at study inclusion date
-Need for perioperative clotting factor concentrates
-Treatment duration with FVIII-concentrates of at least 48 hours
-Results of FVIII levels after a DDAVP test dose, or if test results are not admissible, willingness to undergo a DDAVP test
-Male gender
-(Parental) informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

-Patients with other congenital or acquired hemostatic abnormalities
-Very low response to DDAVP after 1 hour – absolute increase in FVIII < 0.2 IU/mL
-Detectable FVIII inhibiting antibodies (>0.2 BU) in medical history or preoperatively, unless successfully treated with immunotolerance therapy
-Contraindications for DDAVP, e.g. cardiovascular disease (see appendix IV)
-Use of co-medication that has an interaction with DDAVP (see appendix IV)
-Intolerance to previous DDAVP administrations
-DDAVP not advisable due to the type of surgery according to the hematologist and/or surgeon

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified