Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
NCT ID: NCT03967249
Last Updated: 2023-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2019-07-25
2022-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IONIS GHR-LRx + Somatostatin Receptor Ligand (SRL)
IONIS GHR-LRx (as per dose in previous study) will be administered subcutaneously once every 28 days for 53 weeks.
IONIS GHR-LRx
Participants will receive IONIS GHR-LRx by subcutaneous injection.
Somatostatin Receptor Ligand (SRL)
Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.
Interventions
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IONIS GHR-LRx
Participants will receive IONIS GHR-LRx by subcutaneous injection.
Somatostatin Receptor Ligand (SRL)
Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with confirmed stable monthly regimen of SRL for 3 months prior to screening
* Able and willing to participate in a 53-week treatment and 14-week post-treatment study
Exclusion Criteria
* Participant who received surgery for pituitary adenoma in the last 3 months prior to screening and participants needing and/or planning to receive surgery for the pituitary adenoma during the trial
* Unwilling to comply with required study procedures during the treatment and post-treatment periods
18 Years
75 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Northwestern University
Evanston, Illinois, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
Budapest, , Hungary
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Endocrinology clinic
Kaunas, , Lithuania
Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika
Vilnius, , Lithuania
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o. o.
Krakow, , Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, , Poland
Mazowiecki Szpital Brodnowski
Warsaw, , Poland
Multi-field Medical Clinic Anturium LLC
Barnaul, , Russia
Interregional Clinical Diagnostic Center
Kazan', , Russia
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
Kemerovo, , Russia
Federal State Budget Institution "National Medical Research Center of Endocrinology" of the Ministry of Healthcare of the Russian Federation
Moscow, , Russia
I.M. Sechenov Moscow First State Medical University
Moscow, , Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, , Russia
Orenburg Regional Clinical Hospital
Orenburg, , Russia
Almazov National Medical Research Centre
Saint Petersburg, , Russia
State Budget Healthcare Institution of the Tver Region (Regional Clinical Hospital)
Tver', , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Countries
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Other Identifiers
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2019-000591-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISIS 766720-CS3
Identifier Type: -
Identifier Source: org_study_id
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