NCT00308464

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.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Geographic Reach
12 countries

35 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 18, 2011

Status Verified

May 1, 2011

Enrollment Period

1.4 years

First QC Date

March 27, 2006

Last Update Submit

May 17, 2011

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in PD and glycemic control

    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

    At week 4 and follow-up

  • +1 more secondary outcomes

Interventions

PHA-794428DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients with severe AGHD.
  • Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.

You may not qualify if:

  • AGHD patients with uncontrolled pituitary tumor growth.
  • Tumors within 3 mm of the optic chiasm.
  • Patients with diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Pfizer Investigational Site

Edegem, 2650, Belgium

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Hradec Králové, 500 05, Czechia

Location

Pfizer Investigational Site

Prague, 128 08, Czechia

Location

Pfizer Investigational Site

Aarhus C, DK-8000, Denmark

Location

Pfizer Investigational Site

Herlev, 2730, Denmark

Location

Pfizer Investigational Site

Koebenhavn OE, 2100, Denmark

Location

Pfizer Investigational Site

Odense C, DK-5000, Denmark

Location

Pfizer Investigational Site

Marseille, 13385, France

Location

Pfizer Investigational Site

Paris, 75013, France

Location

Pfizer Investigational Site

Reims, 51092, France

Location

Pfizer Investigational Site

Dresden, 01307, Germany

Location

Pfizer Investigational Site

Marburg, 35043, Germany

Location

Pfizer Investigational Site

München, 80804, Germany

Location

Pfizer Investigational Site

Messina, 98125, Italy

Location

Pfizer Investigational Site

Milan, 20122, Italy

Location

Pfizer Investigational Site

Napoli, 80131, Italy

Location

Pfizer Investigational Site

Roma, 00168, Italy

Location

Pfizer Investigational Site

Torino, 10126, Italy

Location

Pfizer Investigational Site

Leiden, 2333 ZA, Netherlands

Location

Pfizer Investigational Site

Lodz, 93-338, Poland

Location

Pfizer Investigational Site

Wroclaw, 50-367, Poland

Location

Pfizer Investigational Site

Ľubochňa, Slovakia, 034 91, Slovakia

Location

Pfizer Investigational Site

Bratislava, 826 06, Slovakia

Location

Pfizer Investigational Site

Alicante, Alicante, 03010, Spain

Location

Pfizer Investigational Site

Granada, Granada, 18012, Spain

Location

Pfizer Investigational Site

Santiago de Compostela, La Coruña, 15706, Spain

Location

Pfizer Investigational Site

Gothenburg, 413 45, Sweden

Location

Pfizer Investigational Site

Linköping, 581 85, Sweden

Location

Pfizer Investigational Site

Lund, 221 85, Sweden

Location

Pfizer Investigational Site

Umeå, 901 85, Sweden

Location

Pfizer Investigational Site

London, EC1A 7BE, United Kingdom

Location

Pfizer Investigational Site

Manchester, M20 4BX, United Kingdom

Location

Pfizer Investigational Site

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 19654233DERIVED

Related Links

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 29, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 18, 2011

Record last verified: 2011-05

Locations

BE(3)FR(3)GB(3)DK(4)SL(2)PL(2)ES(3)IT(5)CZ(2)NL(1)SE(4)DE(3)