Long Term Study With B2036-PEG

July 24, 2008 updated by: Pfizer

Long-Term Study of B2036-PEG in Acromegaly - Long Term Study With B2036-PEG -

Primary objective: To investigate the efficacy and safety of Pegvisomant in Japanese patients with acromegaly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

16

Phase

  • Phase 3

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

      • Gakuhara, Kishiwada, Osaka, Japan, 596-8501
        • Pfizer Investigational Site
      • Kyoto, Japan, 612-8555
        • Pfizer Investigational Site
      • Sannomaru-cho, Naka-ku, Nagoya-shi, Japan, 460-0001
        • Pfizer Investigational Site
    • Hyogo Pref
      • Kobe City, Hyogo Pref, Japan, 650-0017
        • Pfizer Investigational Site
    • Kanagawa
      • Kozukue-cho, Kouhoku-ku, Yokohama-shi, Kanagawa, Japan, 222-0036
        • Pfizer Investigational Site
    • Shizuoka-ken
      • Hamamatsu-shi, Shizuoka-ken, Japan, 431-3124
        • Pfizer Investigational Site
    • Tokyo
      • Bonkyo-ku, Tokyo, Japan, 113-0022
        • Pfizer Investigational Site
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • 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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009).

Exclusion Criteria:

  • Switching to other therapeutic methods for acromegaly

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the safety and efficacy of long-term B2036-PEG therapy in patients with acromegaly

Secondary Outcome Measures

Outcome Measure
PK/PD evaluation

Collaborators and Investigators

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

Sponsor

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.

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

April 1, 2004

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2008

Last Update Submitted That Met QC Criteria

July 24, 2008

Last Verified

July 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acromegaly

Clinical Trials on Pegvisomant

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