Theophylline for Treatment of Pseudohypoparathyroidism

Launched by ASHLEY SHOEMAKER · Jan 21, 2020

Keywords

ClinConnect Summary

Trial Objectives

1. The primary objective of this study is to evaluate the long-term safety of theophylline in patients with PHP.
2. The secondary objectives of this study are to evaluate changes in BMI, hormone resistance and epiphyseal closure associated with theophylline treatment of patients with PHP.

Study Design The proposed study is a single center, 24-month open label extension clinical trial for patients with PHP who complete the randomized clinical trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Successful completion of the randomized clinical trial "Phase 2 Study of Theophylline Treatment of Pseudohypoparathyroidism IND 133103 (11/1/2016)".
• Exclusion Criteria:
• • 1. History of a seizure disorder unrelated to hypocalcemia
• • 2. History of a cardiac arrhythmia (not including bradycardia)
• • 3. Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \>3x upper limit of normal)
• • 4. Congestive heart failure
• • 5. Current cigarette use or alcohol abuse
• • 6. Pregnancy or intention to become pregnant during the next year
• • 7. Active peptic ulcer disease
• • 8. Current use of medications known to effect theophylline levels
• • 9. History of hypersensitivity to theophylline or other medication components
• • 10. Unable to comply with study procedures in the opinion of the investigator