4213 alleviate1: Giving N8-GP by subcutaneous injection
Research type
Research Study
Full title
Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with haemophilia A
IRAS ID
213087
Contact name
Pratima Chowdary
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2016-002396-99
Clinicaltrials.gov Identifier
UTN (Universal Trial Number), U1111-1183-5111
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
People with severe haemophilia A have an increased tendency to suffer bleeding. Regular intravenous injections of coagulation factor VIII are commonly used to prevent this bleeding (prophylaxis).
The trial product to be tested in this study is designed to prevent bleeding in people with haemophilia. It has previously been given to over 200 patients by intravenous injection (injection into a vein) in clinical trials. This trial will be the first time it will be given by sub-cutaneous injection (injection under the skin). Subcutaneous injections are expected to be easier for patients and to have a lower risk of infection but the safety of giving the trial product by injection under the skin has not been tested in humans before.
The trial is in two parts, A and B. In both parts, subjects will give informed consent before being screened to ensure they meet all the criteria for participation.
In part A, participants will have only a single dose of the trial product followed by a series of visits over 7 to 8 days in which blood samples will be taken. This part of the trial will determine the best dose of the trial product to use for part B.
In part B, participants will have daily injections of the trial product for 3 months. Frequent clinic visits will be required especially at the beginning and end of the 3 month period.
Participants completing either parts of the trial will attend 2 follow-up visits, 14 and 28 days after their last dose.
Participants must stop taking their usual prophylaxis during the trial but can resume during the follow-up period. The trial will take place at hospitals with experience of performing clinical trials in haemophilia.REC name
London - Central Research Ethics Committee
REC reference
16/LO/1794
Date of REC Opinion
1 Dec 2016
REC opinion
Further Information Favourable Opinion