Safety and Efficacy of Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes: a Randomized Controlled Study
Who is this study for? Children with interstitial lung diseases with genetic causes
What treatments are being studied? Hydroxychloroquine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:
• 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
• Signed and dated informed consent of the subject (if subject has the ability) and the representatives (of underaged children) must be available before start of any specific trial procedures
Locations
Other Locations
China
Children's hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Liling Qian, Doctor
llqian@126.com
021-64931913
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2027-04
Participants
Target number of participants: 60
Treatments
Experimental: Hydroxychloroquine
Hydroxychloroquine in a dose of 10 mg/kg\*d, p.o., bid for 12 months. The maximum daily dose is 400mg.
No_intervention: control
control group which do not take hydroxychloroquine for treatment.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University