NCT02615938

Hydroxychloroquine (HCQ) in Pediatric Interstitial Lung Disease (ILD)

Hydroxychloroquine in Pediatric ILD: START Randomized Controlled in Parallel-group, Then Switch Placebo to Active Drug, and STOP Randomized Controlled in Parallel-Group to Evaluate the Efficacy and Safety of Hydroxychloroquine (HCQ)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Matthias Griese · Academic / Other
• Sex: All
• Age: 3 Weeks – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multinational study investigating the initiation or withdrawal of hydroxychloroquine in subjects with chILD.

Detailed description

This study is an explorative, prospective, randomized, double-blind, placebo controlled investigation of hydroxychloroquine (HCQ) in pediatric ILD. The treatments are organized in START and STOP blocks, which can be initiated in sequence, as needed by the subjects. Each patient can participate in each block only once. In the START block subjects are randomized to parallel-groups, then the placebo group is switched to active drug. In the STOP block, subjects on HCQ are randomized into parallel-groups treated with placebo or HCQ to investigate the withdrawal of HCQ for assessment of its efficacy.

Conditions

• Interstitial Lung Disease
• Diffuse Parenchymal Lung Disease
• Children´s Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine sulfate	Apply drug to modify lysosomal pH
OTHER	Placebo	Apply Placebo not to modify lysosomal pH

Timeline

• Start date: 2015-08-21
• Primary completion: 2019-06-27
• Completion: 2020-09-09
• First posted: 2015-11-26
• Last updated: 2025-12-03
• Results posted: 2025-12-03

Locations

9 sites across 1 country: Germany