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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ambrilia Biopharma, Inc.

Criteria

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