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

May 17, 2011 updated by: Pfizer

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

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.

Study Overview

Status

Terminated

Conditions

Growth Hormone Deficiency

Intervention / Treatment

Drug: PHA-794428

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.

Study Type

Interventional

Enrollment

136

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Edegem, Belgium, 2650
    - Pfizer Investigational Site
  - Gent, Belgium, 9000
    - Pfizer Investigational Site
  - Leuven, Belgium, 3000
    - Pfizer Investigational Site
Czech Republic
- - Hradec Kralove, Czech Republic, 500 05
    - Pfizer Investigational Site
  - Praha 2, Czech Republic, 128 08
    - Pfizer Investigational Site
Denmark
- - Aarhus C, Denmark, DK-8000
    - Pfizer Investigational Site
  - Herlev, Denmark, 2730
    - Pfizer Investigational Site
  - Koebenhavn OE, Denmark, 2100
    - Pfizer Investigational Site
  - Odense C, Denmark, DK-5000
    - Pfizer Investigational Site
France
- - Marseille Cedex 5, France, 13385
    - Pfizer Investigational Site
  - Paris, France, 75013
    - Pfizer Investigational Site
  - Reims Cedex, France, 51092
    - Pfizer Investigational Site
Germany
- - Dresden, Germany, 01307
    - Pfizer Investigational Site
  - Marburg, Germany, 35043
    - Pfizer Investigational Site
  - Muenchen, Germany, 80804
    - Pfizer Investigational Site
Italy
- - Messina, Italy, 98125
    - Pfizer Investigational Site
  - Milano, Italy, 20122
    - Pfizer Investigational Site
  - Napoli, Italy, 80131
    - Pfizer Investigational Site
  - Roma, Italy, 00168
    - Pfizer Investigational Site
  - Torino, Italy, 10126
    - Pfizer Investigational Site
Netherlands
- - Leiden, Netherlands, 2333 ZA
    - Pfizer Investigational Site
Poland
- - Lodz, Poland, 93-338
    - Pfizer Investigational Site
  - Wroclaw, Poland, 50-367
    - Pfizer Investigational Site
Slovakia
- - Bratislava, Slovakia, 826 06
    - Pfizer Investigational Site
  - Lubochna, Slovakia, 034 91
    - Pfizer Investigational Site
Spain
- - Alicante, Spain, 03010
    - Pfizer Investigational Site
  - Granada, Spain, 18012
    - Pfizer Investigational Site
- La Coruña
  - Santiago de Compostela, La Coruña, Spain, 15706
    - Pfizer Investigational Site
Sweden
- - Göteborg, Sweden, 413 45
    - Pfizer Investigational Site
  - Linköping, Sweden, 581 85
    - Pfizer Investigational Site
  - Lund, Sweden, 221 85
    - Pfizer Investigational Site
  - Umeå, Sweden, 901 85
    - Pfizer Investigational Site
United Kingdom
- - London, United Kingdom, EC1A 7BE
    - Pfizer Investigational Site
  - Manchester, United Kingdom, M20 4BX
    - Pfizer Investigational Site
  - Oxford, United Kingdom, OX3 7LJ
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure	Time Frame
Change in PD and glycemic control Time Frame: At weeks 4 and 7	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	At week 4 and follow-up
Injection site reactions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B; GH Lipoatrophy Study Group. Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol. 2009 Oct;161(4):533-40. doi: 10.1530/EJE-09-0422. Epub 2009 Aug 4.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)