Growth Hormone Deficiency
Conditions
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.
Interventions
DRUGPHA-794428
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients with severe AGHD. * Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.
Exclusion criteria
* AGHD patients with uncontrolled pituitary tumor growth. * Tumors within 3 mm of the optic chiasm. * Patients with diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in PK concentrations. | — |
| ALT, AST greater than 3.0 times ULN at any visit | — |
| Change in PD and glycemic control | At weeks 4 and 7 |
| Change in body weight | At week 4 and follow-up |
| Injection site reactions | — |
| Anti-hGH and anti PHA-794428 antibody production | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed