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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002190-66 | EudraCT Number |
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The purpose of this trial is to assess the long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Patients completing the main part of the trial will be offered 52 weeks continued open-label treatment in an extension part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAM2029 (octreotide subcutaneous depot) | Experimental | CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment with an option of extension. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAM2029 (octreotide subcutaneous depot) | Drug | Octreotide subcutaneous depot for monthly injections in acromegaly patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of adverse events (AEs) | Week 0-52 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN | Week 50 to 52 | |
| Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L | Week 50 to 52 | |
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Inclusion Criteria:
Exclusion Criteria:
For Roll-over Patients from NCT04076462:
For New Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Diego Ferone, M.D | University of Genova Endocrinology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Department of Medicine Division of Endocrinology | Los Angeles | California | 90095 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40418492 | Derived | Glatard A, Friberg-Hietala S, Keutzer L, Hansson A, Johnsson M, Tiberg F. Population Pharmacokinetic Analysis of an Octreotide Depot (CAM2029) in the Treatment of Acromegaly. Clin Pharmacokinet. 2025 Jul;64(7):1079-1092. doi: 10.1007/s40262-025-01522-3. Epub 2025 May 26. |
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| Proportion of patients/partners declared competent by a healthcare professional to administer intervention |
During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place |
| Week 0-52 |
| Octreotide plasma concentrations over time | Week 0-52 |
| Stanford University Medical Center |
| Palo Alto |
| California |
| 94305 |
| United States |
| Prufen Clinical Research LLC | Miami | Florida | 33130 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University in St. Louis, School of Medicine | St Louis | Missouri | 63110 | United States |
| Palm Research Center | Las Vegas | Nevada | 89148 | United States |
| Columbia University Medical Center | New York | New York | 10018 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny Endocrinology Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Institute of Dallas | Dallas | Texas | 75231 | United States |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin | Frankfurt | 60590 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79601 | Germany |
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV | Munich | 80336 | Germany |
| Medicover Neuroendokrinologie | Munich | 81667 | Germany |
| Medicover Oldenburg MVZ | Oldenburg | 26122 | Germany |
| General Hospital of Athens "Laiko", Endocrinology University Clinic | Athens | 115 27 | Greece |
| Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism | Athens | 115 28 | Greece |
| General Hospital of Thessaloniki "Ippokratio" | Thessaloniki | 546 42 | Greece |
| Military Health Center, 2nd Department of Internal Medicine | Budapest | 1062 | Hungary |
| SZTE ÁOK I.sz. Belgyógyászati Klinika | Szeged | 6720 | Hungary |
| IRCCS Policlinico San Martino | Genova | 16132 | Italy |
| Azienda Universitaria "Federico II" | Naples | 80131 | Italy |
| Azienda Ospedaliera Padova, Department of Internal medicine | Padova | 35128 | Italy |
| Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology | Roma | Italy |
| AOUI Verona, Policlinic of GB Rossi | Verona | 37134 | Italy |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Krakow | 30-688 | Poland |
| Centrum Nowoczesnych Terapii "Dobry Lekarz" | Krakow | 31-011 | Poland |
| Amicare Sp. z o.o. Sp. K. | Lodz | 90-644 | Poland |
| Piekarskie Centrum Medyczne, Szpital Miejski | Piekary Śląskie | 41-940 | Poland |
| Interregional Clinical Diagnostic Center | Kazan' | 420087 | Russia |
| "Atlas" Medical Center | Moscow | Russia |
| Sechenov Moscow First State Medical University | Moscow | Russia |
| Vladimirsky Moscow Regional Research Clinical Institute | Moscow | Russia |
| Novosibirsk State Regional Clinical Hospital | Novosibirsk | 630087 | Russia |
| Interregional Clinical Diagnostic Center | Ryazan | 420087 | Russia |
| Saratov Regional Clinic Hospital | Saratov | 410053 | Russia |
| Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases | Belgrade | 11000 | Serbia |
| Clinical Centre of Vojvodina, Clinic for endocrinology, diabetes and metabolic diseases | Novi Sad | 21000 | Serbia |
| University Hospital Complex A Coruña | A Coruña | 15006 A | Spain |
| University Hospital of Alicante | Alicante | 03010 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Gregorio Marañón | Madrid | 28009 | Spain |
| Hospital Regional Universitario de Málaga | Málaga | 29010 | Spain |
| Complejo Hospitalario Universitario Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| University Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitario y Politécnico La Fé | Valencia | 46026 | Spain |
| Hospital Universitario de la Ribera | Valencia | 46600 | Spain |
| Akdeniz University Faculty of Medicine Department of Endocrinology | Antalya | 07985 | Turkey (Türkiye) |
| Aydın Adnan Menderes University Research and Application Hospital | Aydin | 09010 | Turkey (Türkiye) |
| Pamukkale University Faculty of Medicine Department of Endocrinology | Denizli | 20070 | Turkey (Türkiye) |
| Eskisehir Osmangazi University Medical Faculty | Eskişehir | 26480 | Turkey (Türkiye) |
| Istanbul University Medical Faculty | Fatih | 34098 | Turkey (Türkiye) |
| Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism | Kocaeli | 41000 | Turkey (Türkiye) |
| Inonu University Medical Faculty Endocrinology Department | Malatya | 44000 | Turkey (Türkiye) |
| Erciyes University Medical Faculty, Dept. of Endocrinology | Melikgazi | 38039 | Turkey (Türkiye) |
| Karadeniz Technical University Farabi Hospital | Trabzon | 61080 | Turkey (Türkiye) |
| Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus | Zonguldak | 67600 | Turkey (Türkiye) |
| College of Medical and Dental Sciences | Birmingham | B15 2TT | United Kingdom |
| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS97TF | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Salford Royal Foundation Trust | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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