Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
1 other identifier
interventional
63
6 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2007
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 11, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJune 4, 2009
June 1, 2009
1.7 years
March 11, 2008
June 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subjects who have completed the 24-week C2L-OCT-01 PR-301 study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Republican Centre for Medical Rehabilitation and Water-therapy
Minsk, Belarus
Semmelweis Egyetem Altalanos Orvostudomanyi
Budapest, Hungary
Institue of Endocrinology "C.I Parhon" Bucharest
Bucharest, Romania
Institute of Endocrinology, University Clinical Center
Belgrade, Serbia
Fakultna Nemocnica s Poliklinkow Bratislava
Bratislava, Slovakia
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
Kiev, Ukraine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Raphael Naudin, M.D.
Ambrilia Biopharma, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 11, 2008
First Posted
March 14, 2008
Study Start
October 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 4, 2009
Record last verified: 2009-06