Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age1-18
SponsorChildren's Hospital of Fudan University
About this trial
The aim of this proposed study is to evaluate the efficacy and safety of hydroxychloroquine (HCQ) in children's interstitial lung diseases(chILD) with genetic causes. This study is a randomized controlled clinical trial.
Eligibility criteria
Qualifiers
A clinical diagnosis of chILD with age<18 years
Genetically diagnosed (e.g. SFTPC, SFTPB, ABCA3, NKX2-1, CSF2RA, CSF2RB, IARS, MARS, COPA, SLC7A7, LRBA)
Patients have to be clinically stable with no major changes in their medication in the last 4 weeks
No HCQ treatment in the last 12 weeks
Disqualifiers
Acute severe infectious exacerbations
Known hypersensitivity to HCQ, or other ingredients of the tablets
Proven retinopathy or maculopathy
Renal insufficiency at screening, defined as glomerular filtration rate (GFR)< 40 mL/min/1.73 m2 in patients aged 3 to 8 weeks< 60 mL/min/1.73 m2 in patients ≥ 8 weeks of age
Trial design
Treatments tested in this trial
- Hydroxychloroquine
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov