None listed
Conditions
Brief summary
Coeliac disease is a serious illness in which the immune system reacts badly to gluten, a protein found in wheat, rye, and barley. This reaction damages the lining of the small intestine and causes a range of unpleasant symptoms. The only treatment is a strict gluten-free diet, which usually helps to settle symptoms and allow the intestine to heal. However, this treatment is challenging and for some people even small amounts of gluten intake is associated with persistent symptoms and/or small intestinal damage. Currently, there are limited treatment options in this situation and there is a need to address this unmet need. The aim of this study is to test if HCQ can reduce immune responses to gluten in people with coeliac disease.
Interventions
This is a single centre, open-label, non-randomised prospective study. This study will recruit adult participants with treated CD who will take hydroxychloroquine (HCQ) for 6 weeks. A control cohort of treated CD participants will have the same immune readouts measured without taking HCQ.
Hydroxychloroquine 400mg (>65kg body weight) or hydroxychloroquine 200mg (=65kg body weight) once daily for up to 42 days. Dosing is based on participant weight to maximise safety and tolerability. Participan
This is a single centre, open-label, non-randomised prospective study. This study will recruit adult participants with treated CD who will take hydroxychloroquine (HCQ) for 6 weeks. A control cohort of treated CD participants will have the same immune readouts measured without taking HCQ. Hydroxychloroquine 400mg (>65kg body weight) or hydroxychloroquine 200mg (=65kg body weight) once daily for up to 42 days. Dosing is based on participant weight to maximise safety and tolerability. Participants with known contra-indications to hydroxychloroquine will be excluded from the study. To monitor medication adherence, participants will document the date an time of each at home medication dose in a study diary. They will also be asked to return all medication packaging at each study visit for drug accountability. Recruitment, blood collection and gluten challenges will be undertaken at the Clinical Translation Centre, Walter and Eliza Hall Institute (CTC WEHI) or Clinical Translation Centre at the Royal Melbourne Hospital (CTC RMH).
Sponsors
Walter and Eliza Hall Institute of Medical Research
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Study participant is willing to provide informed consent 2. Be aged 18-70 years at the time of consent 3. Participants with medically confirmed CD following a strict gluten free diet for at least 12 months
Exclusion criteria
1. Those who do not meet inclusion criteria 2. Cardiac disease (including arrhythmias) 3. Pre-existing eye disorders including retinal eye disease 4. Liver disease 5. Kidney disease 6. QTc interval >460msec in men and >480 msec in women on baseline ECG 7. Any contra-indication to hydroxychloroquine or chloroquine including allergy or hypersensitivity 8. Concurrent medications which can prolong QT interval 9. Currently taking or planning to self-treat with hydroxychloroquine or chloroquine 10. Immunosuppressive conditions or medications 11. Diabetes (type 1 or 2) 12. Pregnancy or breast feeding 13. Donated whole blood in last 6 week or plasma in last 2 weeks at the screening visit 14. Inability to follow study procedures during the trial period 15. Inability to provide informed consent 16. Lack of fluency in the English language
Outcome results
None listed