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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C2L-OCT-01 PR 30 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
•Subjects who have completed the 24-week C2L-OCT-01 PR-301 study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphael Naudin, M.D. | Ambrilia Biopharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Centre for Medical Rehabilitation and Water-therapy | Minsk | Belarus | ||||
| Semmelweis Egyetem Altalanos Orvostudomanyi |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| 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 |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |