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Hydroxychloroquin (HCQ) in Pediatric Interstitial Lung Disease (ILD) — HCQ-chILD-EU  

Interstitial Lung Disease Clinical Trial

Official title:
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)

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02615938
Study type Interventional
Source Ludwig-Maximilians - University of Munich
Contact
Status Suspended
Phase Phase 2
Start date April 2015
Completion date April 2025
View Details
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