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

Primary Purpose

Growth Hormone Deficiency

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PHA-794428
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Change in PD and glycemic control
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
Injection site reactions

Full Information

First Posted
March 27, 2006
Last Updated
May 17, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00308464
Brief Title
A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
136 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PHA-794428
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in PD and glycemic control
Time Frame
At weeks 4 and 7
Title
Change in PK concentrations.
Title
ALT, AST greater than 3.0 times ULN at any visit
Title
Anti-hGH and anti PHA-794428 antibody production
Title
Change in body weight
Time Frame
At week 4 and follow-up
Title
Injection site reactions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Aarhus C
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Koebenhavn OE
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Pfizer Investigational Site
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Pfizer Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Pfizer Investigational Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80804
Country
Germany
Facility Name
Pfizer Investigational Site
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Lubochna
ZIP/Postal Code
034 91
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Pfizer Investigational Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Pfizer Investigational Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19654233
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6391003&StudyName=A%20Study%20To%20Evaluate%20The%20Dose%20Response%20And%20Safety%20Of%20PHA-794428%20In%20Adults%20With%20Growth%20Hormone%20Deficiency
Description
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A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency

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