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NCT00308464 Clinical Trial

A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency

Growth Hormone Deficiency Clinical Trial

Official title:
A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00308464
Other study ID # A6391003
Secondary ID
Status Terminated
Phase Phase 2
First received March 27, 2006
Last updated May 17, 2011
Start date July 2006
Est. completion date December 2007

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 136
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PHA-794428

Locations
Country Name City State
Belgium Pfizer Investigational Site Edegem
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Leuven
Czech Republic Pfizer Investigational Site Hradec Kralove
Czech Republic Pfizer Investigational Site Praha 2
Denmark Pfizer Investigational Site Aarhus C
Denmark Pfizer Investigational Site Herlev
Denmark Pfizer Investigational Site Koebenhavn OE
Denmark Pfizer Investigational Site Odense C
France Pfizer Investigational Site Marseille Cedex 5
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Reims Cedex
Germany Pfizer Investigational Site Dresden
Germany Pfizer Investigational Site Marburg
Germany Pfizer Investigational Site Muenchen
Italy Pfizer Investigational Site Messina
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Torino
Netherlands Pfizer Investigational Site Leiden
Poland Pfizer Investigational Site Lodz
Poland Pfizer Investigational Site Wroclaw
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Lubochna
Spain Pfizer Investigational Site Alicante
Spain Pfizer Investigational Site Granada
Spain Pfizer Investigational Site Santiago de Compostela La Coruña
Sweden Pfizer Investigational Site Göteborg
Sweden Pfizer Investigational Site Linköping
Sweden Pfizer Investigational Site Lund
Sweden Pfizer Investigational Site Umeå
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Oxford

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  Slovakia,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Change in PD and glycemic control At weeks 4 and 7
Secondary Change in PK concentrations.
Secondary ALT, AST greater than 3.0 times ULN at any visit
Secondary Anti-hGH and anti PHA-794428 antibody production
Secondary Change in body weight At week 4 and follow-up
Secondary Injection site reactions
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Recruiting NCT02908958 - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency Phase 4
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