A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00314938
First received: April 13, 2006
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling


Condition Intervention Phase
Growth Hormone Deficiency
Drug: PHA-794428
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • PK, IGF-1 and safety measurements up to 2 weeks after dosing

Secondary Outcome Measures:
  • Antibody and IGFBP-3 measurements

Estimated Enrollment: 32
Study Start Date: April 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Male and female children with a minimum age of 6 years
  • 2. Prepubertal as defined by Tanner staging
  • 3. Growth hormone deficiency

Exclusion Criteria:

  • 1. PGHD patients with uncontrolled pituitary tumor growth
  • 2. Tumors within 3 mm of the optic chiasm
  • 3. Serum ALT and/or AST >= 1.5 times the upper limit of normal range
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314938

Locations
Belgium
Pfizer Investigational Site
Brussel, Belgium, 1090
Pfizer Investigational Site
Bruxelles, Belgium, 1050
Pfizer Investigational Site
Edegem, Belgium, 2650
France
Pfizer Investigational Site
Paris, France, 75019
Germany
Pfizer Investigational Site
Erlangen, Germany, 91054
Israel
Pfizer Investigational Site
Petach Tikva, Israel, 49202
United Kingdom
Pfizer Investigational Site
Cardiff, United Kingdom, CF14 4XN
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00314938     History of Changes
Other Study ID Numbers: A6391004
Study First Received: April 13, 2006
Last Updated: May 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on October 20, 2014