Viewing Study NCT03967249



Ignite Creation Date: 2024-05-06 @ 1:12 PM
Last Modification Date: 2024-10-26 @ 1:11 PM
Study NCT ID: NCT03967249
Status: COMPLETED
Last Update Posted: 2023-03-22
First Post: 2019-05-23

Brief Title: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Sponsor: Ionis Pharmaceuticals Inc
Organization: Ionis Pharmaceuticals Inc

Study Overview

Official Title: An Open-Label Extension Trial of IONIS GHR-LRx an Antisense Inhibitor of the Growth Hormone Receptor Administered Monthly Subcutaneously to Patients With Acromegaly Being Treated With Long-Acting Somatostatin Receptor Ligands SRL
Status: COMPLETED
Status Verified Date: 2023-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to assess the safety and efficacy of extended dosing with IONIS GHR-LRx in participants with acromegaly as add-on to somatostatin receptor ligands SRL therapy
Detailed Description: This extension study will include participants up to 60 participants with acromegaly from Study NCT03548415 All participants will remain on the same dose from the previous study and receive IONIS GHR-LRx SC injection once every 28 days as add-on to SRL therapy for 53 weeks At the end of 53 weeks participants will enter a 14-week post-treatment PT evaluation period

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2019-000591-42 EUDRACT_NUMBER None None