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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
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.
Change in PD and glycemic control
Time frame: 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
Time frame: At week 4 and follow-up
Injection site reactions
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Pfizer Investigational Site
Edegem, Belgium
Pfizer Investigational Site
Ghent, Belgium
Pfizer Investigational Site
Leuven, Belgium
Pfizer Investigational Site
Hradec Králové, Czechia
Pfizer Investigational Site
Prague, Czechia
Pfizer Investigational Site
Aarhus C, Denmark
Pfizer Investigational Site
Herlev, Denmark
Pfizer Investigational Site
Koebenhavn OE, Denmark
Pfizer Investigational Site
Odense C, Denmark
Pfizer Investigational Site
Marseille, France
...and 25 more locations