Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes

Sponsor
Children's Hospital of Fudan University
Study ID
NCT04532346
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Interstitial Lung Disease
  • Surfactant Dysfunction

Eligibility Criteria

Sex
ALL
Age
1 Month - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Hydroxychloroquine — DRUG
    Hydroxychloroquine Sulfate is an anti-malarial and anti-rheumatic drug. hydroxychloroquine has been reported to improve the clinical status of chILD cases wtih genetic causes. The exact mechanism of action of hydroxychloroquine is unknown. In additon to having anti-inflammatory properties, hydroxychloroquine has been shown to affect intracellular processing of surfactant protein.

Study Details

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 Dates

First listed
Aug 31, 2020
Start date
Sep 1, 2024
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Oxygenation status [ Time Frame: at first month, at 3rd month, at 6th month, at 12th month ]

Central Contacts

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