HCQ in pediatric ILD v2.0
Research type
Research Study
Full title
Hydroxychloroquine in pediatric ILD\nSTART randomized controlled in parallel-group, then switch placebo to active drug, and STOP randomized controlled in parallel-group to evaluate the efficacy and safety of hydroxychloroquine (HCQ)
IRAS ID
195350
Contact name
Child EU Office
Contact email
Sponsor organisation
Klinikum der Universität München
Eudract number
2013-003714-40
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Interstitial lung diseases in children (chILD) are a group of more than 200 conditions, all of which are rare. There is still no known proven treatment available. All current treatments are decided by trial and error or from anecdotal reports. The most commonly tried treatment is steroids, especially hydroxychloroquine. This research will measure if hydroxychloroquine is more or less effective than a dummy pill (placebo). There will be 2 separate studies. Study 1 - START Hydroxycholorquine: This first study will look at children who are not receiving hydroxychloroquine but whose doctor believes they may benefit from it. These children will be split randomly into two groups. One group will start right away to take Hydroxycholoroquine for 56 days. The other group will start with a dummy tablet and only after 28 days will they start to receive Hydroxychloroquine. Study 2 - STOP Hydroxychloroquine: This second study will look at children who are receiving hydroxychloroquine but whose doctor are planning to reduce or stop this treatment. These children will be split randomly into two groups. One group will continue to take the same dose of Hydroxycholoroquine for another 3 months. The other group will receive a dummy tablet instead of Hydroxychloroquine. After 3 months both groups will stop receiving medication. This will allow us to measure how well hydroxychloroquine works and how safe it is.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0132
Date of REC Opinion
6 Jan 2017
REC opinion
Further Information Favourable Opinion