Recruiting

Theophylline

Sponsor:

Massachusetts General Hospital

Code:

NCT03718403

Conditions

PHP Ia

PHP IB

Php1C

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Interventions

Theophylline

Study Details

Brief summary:

The study evaluates the effect of theophylline in 100 subjects with Pseudohypoparathyroidism.

Conditions

PHP Ia

PHP IB

Php1C

Study ID

NCT03718403

Start date

Nov 11, 2019

Status verified date

Jul, 2022

Completion date

Apr 10, 2032

Anticipated

Primary completion date

Apr 10, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects with known diagnosis of PHP1A and PHP1B
  • Age >5 years

Exclusion Criteria:

  • • Significant kidney disease, i.e. any CKD stage

  • Hypercalciuria
  • Kidney stones
  • Severe Heart disease
  • Uncontrolled seizure disorder
  • Peptic ulcer
  • Liver dysfunction
  • Bleeding disorder
  • Allergy to theophylline preparation
  • Muscle disorder
  • Infection
  • Any neurologic disease
  • Chronic drugs interacting with theophylline

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Single arm open labeled intervention study

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.

Interventions

Theophylline

Theophylline will be given to maintain a peak level between 10-15 mcg/mL

Primary outcome measure

  • Effect of Theophylline on Bone Age in PHP [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

AMITA SHARMA, MD

6177262908asharma5@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Amita Sharma

617-726-2908asharma5@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 22, 2022

Last verified

Jul, 2022

Keywords

  • PHP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2022-07-22.