Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
Phase 3
Completed
- Conditions
- Acromegaly
- Registration Number
- NCT00635765
- Lead Sponsor
- Ambrilia Biopharma, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assess, for up to an additional 96 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6, 5 or 4 weeks in patients who have completed the C2L-OCT-01 PR-301 study. Up to 96 weeks
- Secondary Outcome Measures
Name Time Method To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations. Up to 96 weeks Compare plasma concentrations of C2L-OCT-01 PR. First 6 months
Trial Locations
- Locations (6)
Republican Centre for Medical Rehabilitation and Water-therapy
🇧🇾Minsk, Belarus
Institue of Endocrinology "C.I Parhon" Bucharest
🇷🇴Bucharest, Romania
Semmelweis Egyetem Altalanos Orvostudomanyi
🇭🇺Budapest, Hungary
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
🇺🇦Kiev, Ukraine
Institute of Endocrinology, University Clinical Center
🇷🇸Belgrade, Serbia
Fakultna Nemocnica s Poliklinkow Bratislava
🇸🇰Bratislava, Slovakia