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

Ambrilia Biopharma

Status and phase: Completed; Phase 3

Conditions: Acromegaly

Treatments: Drug: C2L-OCT-01 PR 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00635765

C2L-OCT-01 PR-302

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)