Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Haemophilia B With Inhibitors; Haemophilia A With Inhibitors; Congenital Bleeding Disorder

Treatments: Other: No treatment given

Study type: Interventional

Funder types: Industry

Identifiers

NCT02541942

NN1731-4214

U1111-1169-6103 (Other Identifier)

2015-001919-13 (EudraCT Number)

Details and patient eligibility

About

This study is conducted globally. This study describes pharmacogenetic testing of saliva samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue.

Enrollment: 19 patients

Sex: Male

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Informed consent obtained before collection of saliva samples
• Previous participation in adept™2 trial with 5 or more exposure days to rFVIIa analogue

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Collection of specimen

Other group

Treatment:

Other: No treatment given