HS-19-647
Research type
Research Study
Full title
A Phase 3, open-label, single-arm, multi-center trial to assess the long-term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly
IRAS ID
269337
Contact name
Annette Mattsson
Contact email
Sponsor organisation
Camurus AB
Eudract number
2019-002190-66
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This is a Phase 3, open-label, single-arm, multi-center trial that assesses the long-term safety of CAM2029 subcutaneous (SC) depot administered every 4 weeks in patients with acromegaly. CAM2029 represents a novel long-acting pharmaceutical formulation of octreotide for SC administration. The purpose of the study is to assess the overall safety, tolerability and efficacy of CAM2029 in biochemical response for IGF-1 and GH. The study will also evaluate the plasma concentrations of octreotide after administration of CAM2029, patient-reported treatment satisfaction and health-related quality of life parameters. Approximately 140 patients in total will be enrolled with 70 patients directly enrolled in this study and 70 patients rolled-over from a preceding trial (HS-18-633) after informed consent has been obtained. Patients rolling-over from the preceding trial will only participate during 6 months of the trial.
REC name
Wales REC 3
REC reference
19/WA/0331
Date of REC Opinion
18 Nov 2019
REC opinion
Unfavourable Opinion