NCT04532346 Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes
| NCT ID | NCT04532346 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Interstitial Lung Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-09-01 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04532346 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Interstitial Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04532346 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04532346 currently recruiting?
Yes, NCT04532346 is actively recruiting participants. Contact the research team at llqian@126.com for enrollment information.
Where is the NCT04532346 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04532346 clinical trial?
NCT04532346 is sponsored by Children's Hospital of Fudan University. The trial plans to enroll 60 participants.