Status:
COMPLETED
Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
Lead Sponsor:
Ambrilia Biopharma, Inc.
Conditions:
Acromegaly
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- •Subjects who have completed the 24-week C2L-OCT-01 PR-301 study
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00635765
Start Date
October 1 2007
End Date
June 1 2009
Last Update
June 4 2009
Active Locations (6)
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1
Republican Centre for Medical Rehabilitation and Water-therapy
Minsk, Belarus
2
Semmelweis Egyetem Altalanos Orvostudomanyi
Budapest, Hungary
3
Institue of Endocrinology "C.I Parhon" Bucharest
Bucharest, Romania
4
Institute of Endocrinology, University Clinical Center
Belgrade, Serbia