Desmopressin and FVIII concentrate combination treatment in non-severe hemophilia A patients undergoing minor interventions

Phase 1

• Conditions: Hemophilia A; MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850; MedDRA version: 20.0 Level: LLT Classification code 10053753 Term: Hemophilia A without inhibitors System Organ Class: 100000004850; MedDRA version: 20.0 Level: LLT Classification code 10060612 Term: Hemophilia A System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-001875-57-NL
• Lead Sponsor: Erasmus University Medical Center Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-19
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

In order to be eligible for this study, a subject must meet all of the following criteria:
-Non-severe hemophilia A patients (FVIII 0.01-0.40 IU/mL)
-In need of a minor surgical intervention
-Age minimally 12 and maximally 70 years at study inclusion date
-Need for perioperative FVIII concentrates for a maximum of 48 hours
-Having admissible results of a desmopressin test (see paragraph 3.1)
-Absolute increase in FVIII 1 hour after desmopressin administration = 0.2 IU/mL after a previous (test) dose
-Male gender
-(Parental) informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 7
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Patients with other congenital or acquired hemostatic abnormalities
-Clinically relevant FVIII inhibiting antibodies (>0.5 BU) preoperatively, unless successfully treated with immunotolerance therapy
-Needed treatment duration with FVIII concentrates longer than 48 hours
-Contraindications for desmopressin, e.g. cardiovascular disease (see appendix IV)
-Use of co-medication that has an interaction with desmopressin (see appendix IV)
-Intolerance to previous desmopressin administrations

Study & Design

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