Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.

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Detailed Description

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Conditions

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Acromegaly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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C2L-OCT-01 PR 30 mg

Administered by deep IM (gluteus) on Day 1. Beginning on Day 42, drug injection frequency (6, 5 or 4 weeks) and dose modification/adjustment will be allowed for every 3 drug injections based on the mean serum GH and clinical symptoms obtained at the last visit of study C2L-OCT-01 PR-301 and during the course of this study.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

•Subjects who have completed the 24-week C2L-OCT-01 PR-301 study

Exclusion Criteria

* Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating
* Subjects who have experienced any clinically significant adverse event related to study medication in C2L-OCT-01 PR-301 study
* Subjects with uncontrolled Diabetes type II
* Subjects with signs or symptoms related to a tumor compression of the optical chiasm
* Subjects with symptomatic cholelithiasis

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No