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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012842-21 | EudraCT Number |
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The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUR-1008 then Kreon | Experimental |
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| Kreon then EUR-1008 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUR-1008 25,000 Units | Drug | EUR-1008 25,000 Units is a PEP with pancreas powder as the active ingredient.18 Pancreas powder contains various enzymes having proteolytic, lipolytic, and amylolytic activity. Each capsule contains approximately 25,000 Ph. Eur. lipase units. EUR-1008 25,000 consists of orally administered capsules containing enteric-coated beads. |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of Fat Absorption over 72 hours (CFA-72h) | During the last 72 hours of each treatment period, the CFA-72h will be calculated using fat intake data from the diet and fat excretion data from stools. Fat intake will be calculated by the dietician in collaboration with the study investigator using a validated tool. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight at baseline (Visit 2 [Day 0]) and at the end of each treatment period. | 58 days. |
| Coefficient of nitrogen absorption | Coefficient of nitrogen absorption at the end of each treatment period as assessed by a specialised central laboratory by means of Dumas combustion method. |
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Inclusion Criteria:
Definitive diagnosis of CF based on the following:
Pancreatic insufficiency documented by a monoclonal faecal elastase (FE) 100 μg/g stool at screening (test results within the previous 12 months are acceptable)
Currently receiving pancreatic enzyme replacement therapy
Adequate nutritional status based on the following: body mass index (BMI) >19 kg/m2 in adult subjects or a BMI percentile 10th percentile for age in adolescent (12 to 17 years age group) subjects
Are clinically stable with no evidence of concomitant illness or acute upper or lower respiratory tract infection that requires antibiotics during the 7-day interval prior to screening and preceding entry into this clinical study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Taylor, MD, PhD | Sheffield Children's Hospital, The Academic Unit of Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp - Universitair Ziekenhuis Antwerpen (UZA) | Antwerp | Belgium | ||||
| Universitair Ziekenhuis Gent, Centrum voor Mucoviscidose |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32761612 | Derived | Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4. | |
| 27013382 | Derived | Taylor CJ, Thieroff-Ekerdt R, Shiff S, Magnus L, Fleming R, Gommoll C. Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. J Cyst Fibros. 2016 Sep;15(5):675-80. doi: 10.1016/j.jcf.2016.02.010. Epub 2016 Mar 21. |
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| Kreon 25,000 Units | Drug | Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18 Each capsule contains approximately 25,000 Ph. Eur. lipase units. Kreon 25,000 consists of orally administered capsules containing enteric-coated spheres. |
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| 72 hours |
| Control of signs and symptoms of EPI | Control of signs and symptoms of EPI (as recorded in subject diaries). The following will be captured:
| 2- 14 day periods |
| Impact on overall health, daily life, perceived well-being, and symptoms | Impact on overall health, daily life, perceived well-being, and symptoms evaluated using the CFQ (administered by designated study personnel prior to randomisation and at the end of each treatment period). | 58 days |
| Total cholesterol, calculated LDL-C, HDL-C | Total cholesterol, calculated LDL-C, HDL-C (sampling performed prior to randomisation and at the end of each treatment period). | 58 days |
| Treatment Emergent Adverse Events | Frequency, duration, and severity of treatment-emergent adverse events (TEAEs); | 78 days |
| Standard safety laboratory tests | Standard safety laboratory tests, analysed by central laboratory:
| 58 days |
| Vital signs | Vital signs including blood pressure, heart rate, respirations and body temperature. | 78 days |
| Fat-soluble vitamins A, D, and E | Fat-soluble vitamins A, D, and E (sampling performed prior to randomisation and at the end of each treatment period). | 58 days |
| Ghent |
| Belgium |
| Clinic of Paediatric Diseases at UMHAT Dr Georgi Stranski | Pleven | Bulgaria |
| Clinic of Genetic and Paediatric Diseases at UMHAT Sveti Georgi | Plovdiv | Bulgaria |
| Specialized Hospital for Active Treatment of Pulmological and Phtisiatric Disease | Rousse | Bulgaria |
| Multiprofile Clinic for Specialized Pediatric Clinic at MHAT Sveta Marina | Varna | Bulgaria |
| Hôpital Arnaud de Villeneuve | Montpellier | France |
| Nouvel Hôpital Civil | Strasbourg | France |
| Ruhr-Universitaet Bochum - St. Josef Hospital | Bochum | Germany |
| Universitaetsklinikum Carl Gustav Carus an der TU Dresden | Dresden | Germany |
| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitaetsklinikum Essen gGmbH | Essen | Germany |
| Universitätsklinikum Essen Zentrum f.Kinderheilkunde Klinik f.Kinderheilkunde III | Essen | Germany |
| Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin | Jena | Germany |
| Medizinische Klinik Innenstadt | München | Germany |
| Universitaetsklinik für Kinder- und Jugendmedizin Tuebingen | Tübingen | Germany |
| Azienda Ospedaliero Universitaria, Ospedali Riuniti, Ospedale Pediatrico G. Salesi | Ancona | Italy |
| Azienda Ospedale Policlinico di Bari | Bari | Italy |
| University of Catania | Catania | Italy |
| Azienda Ospedaliera Universitaria Policlinico G. Martino, Gastroenterologia Pediatrica E Fibrosi Cistica | Contesse -Messina | Italy |
| University Federico II of Naples, Pediatrics Department | Naples | Italy |
| Clinica di Malattie dell'Apparato Respiratorio | Orbassano (Torino) | Italy |
| Istituto Azienda Ospedaliera Universitaria | Parma | Italy |
| Universita degli Studi di Roma La Sapienza, Azienda Policlinico Umberto I, Dipartimento di Pediatria, Centro Fibrosi Cistica Regione Lazio | Roma | Italy |
| Bambino Gesu Hospital, Cystic Fibrosis Unit | Rome | Italy |
| Ospedale Infantile Regina Margherita | Turin | Italy |
| Azienda Ospedaliera Universitaria Integrata, Centro Fibrosi Cistica-Ospedale Civile Maggiore | Verona | Italy |
| Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem Poradnia Leczenia Mukowiscydozy | Gdansk | Poland |
| Centrum Pulmonologii i Alergologii w Karpaczu | Karpacz | Poland |
| Wojewodzki Szpital Specjalistyczny im Kopernika | Lodz | Poland |
| ALERGOTEST s.c Specjalistyczne Centrum Medyczne | Lublin | Poland |
| Szpital Kliniczny im Karola Jonschera | Poznan | Poland |
| NZOZ Sanatorium Cassia Villa Medica | Rabka-Zdrój | Poland |
| NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii | Rzeszów | Poland |
| Centrum Zdrowia Matki, Dziecka i Mlodziezy | Warsaw | Poland |
| IRMED Irena Wojciechowska | Warsaw | Poland |
| Liverpool Heart and Chest Hospital | Liverpool | United Kingdom |
| Sheffield Children's Hospital, The Academic Unit of Child Health | Sheffield | United Kingdom |
| ID | Term |
|---|---|
| D010188 | Exocrine Pancreatic Insufficiency |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D020799 | Pancrelipase |
| ID | Term |
|---|---|
| D008049 | Lipase |
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010184 | Pancreatic Extracts |
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |
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