A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency
Phase 2
Terminated
- Conditions
- Growth Hormone Deficiency
- Registration Number
- NCT00308464
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.
- Detailed Description
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 136
Inclusion Criteria
- Male and female patients with severe AGHD.
- Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.
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Exclusion Criteria
- AGHD patients with uncontrolled pituitary tumor growth.
- Tumors within 3 mm of the optic chiasm.
- Patients with diabetes mellitus.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range.
- Secondary Outcome Measures
Name Time Method Change in PD and glycemic control At weeks 4 and 7 Change in PK concentrations. ALT, AST greater than 3.0 times ULN at any visit Anti-hGH and anti PHA-794428 antibody production Change in body weight At week 4 and follow-up Injection site reactions
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Oxford, United Kingdom