Long Term Study With B2036-PEG

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

Completed

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Kobe, Hyogo PREF, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegvisomant

Drug

Primary outcomes

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

Secondary outcomes

PK/PD evaluation

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Study completion: 2007
First posted: Sep 2, 2005
Registry last updated: Jul 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed