A Phase 4 interventional study of Theophylline in PHP Ia, PHP IB and Php1C, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Other
The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism.
It is an open label intervention study for the off-label use of theophylline in psuedohypoparathyroidism (PHP).Theophylline is a is non-specific phosphodiesterase inhibitor which increases the levels of secondary messenger,cAMP. PHP patients have end organ resistance to hormones involving cAMP signaling. Thus, theophylline has a potential to abrogate hormone resistance. Also, it may have a role in bone maturation, neurocognition and metabolism.
21 studies on the registry are indexed under Pseudohypoparathyroidism; 8 are open to participants now.
Browse Pseudohypoparathyroidism studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Significant kidney disease, i.e. any CKD stage
Subjects with PHP will be given theophylline to decrease the end organ resistance by increasing levels of cAMP, a second messenger. Theophylline will be dosed twice a day for a period of 52 weeks.
Drug: Theophylline
Theophylline will be given to maintain a peak level between 10-15 mcg/mL
Effect of Theophylline on Bone Age in PHP
Change in Bone age ( in years and months) before and after theophylline administration for 52 weeks
Time frame: 52 weeks
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Massachusetts General Hospital