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Trial · Interventional

CompletedPhase 3Registry data

Long Term Study With B2036-PEG

Overview

Status
Completed
Phase
Phase 3
Enrollment
16 participants
Sponsor
Pfizer · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Japan

Start
Apr 2004
Primary completion
Not stated
Completion
Jul 2007
First posted
2 Sept 2005 (estimated)
Last update posted
29 Jul 2008 (estimated)
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042005200620072008
  1. Ph 3

    Long Term Study With B2036-PEG

    NCT00143416

    Apr 2004 to Jul 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • PegvisomantDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(1)
  1. PK/PD evaluation

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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