Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes

Recruiting now · Early Phase 1

Conditions studied: Interstitial Lung Disease, Surfactant Dysfunction

In brief

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.

Key facts

Study ID

NCT04532346

Run by

Children's Hospital of Fudan University

People needed

60

Starts

2024-09-01

Expected to finish

2027-04-01

Last updated by the study team

2026-03-16

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Participation in other clinical trials during the present clinical trial

Where it is running

• Children's hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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