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

Ambrilia Biopharma, Inc.63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly

Interventions

C2L-OCT-01 PR 30 mgDRUG

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

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

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.

Time frame: Up to 96 weeks

Secondary Outcomes

To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations.

Time frame: Up to 96 weeks

Compare plasma concentrations of C2L-OCT-01 PR.

Time frame: First 6 months

Data from ClinicalTrials.gov

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