RESPONSE
Research type
Research Study
Full title
A randomised, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety, and tolerability of NT100 in pregnant women with a history of unexplained recurrent pregnancy loss (RPL)
IRAS ID
149373
Contact name
Aravinthan Coomarasamy
Contact email
Sponsor organisation
Nora Therapeutics, Inc.
Eudract number
2014-000084-40
Research summary
This study is a double-blind (the participant and their doctors do not know if they are given placebo or the active medicine), placebo-controlled (half of the participants will get placebo and half will get the active medicine), randomised (computer will randomise the participants to either placebo or the active medicine) trial of a new medicine that might reduce the risk of pregnancy loss in women with unexplained recurrent miscarriage.
The tested medicine is a man-made version of a substance naturally made in the body, and is called NT100 (rhG-CSF).
NT100 has some effect on the immune system and might improve the chances of successful implantation of the fetus in the womb. A lot of pregnancy losses are believed to happen because of the problems in this area where the fetus and mother meet. If implantation fails, the pregnancy fails sooner or later.
As with any new medicine it is important to see how safe it is to use it and what the side effects might be. To date in trials of the same medicine in healthy volunteers and women undergoing IVF (In Vitro Fertilisation), there were no serious side effects recorded.
It is also important to find out if women suffering from unexplained recurrent miscarriage are willing to use this medication, and if found to be effective and safe in reducing the pregnancy loss rates, how it can be made easier to use by the patients.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0130
Date of REC Opinion
7 Apr 2014
REC opinion
Further Information Favourable Opinion