Oslo University Hospital
The Paediatric Clinical Trial Unit (P-CTU) is a part of Department of Pediatric Research (PFI) in the Division of Paediatric and Adolescent Medicine at Oslo University Hospital.
The P-CTU was established in 2015 and is located within the Paediatric departments at both Ullevål and Rikshospitalet. It comprises a total of five treatment and observation rooms equipped with advanced monitoring systems, as well as laboratory facilities for sample processing at both locations. The laboratory at PFI is well equipped for advanced biobanking and sample processing. The unit also has access to inpatient beds at the Department of Paediatric Oncology and Haematology. Its central location ensures close proximity to clinical services and facilitates seamless collaboration with inpatient wards and clinical personnel.
Our staff consists of three full-time study coordinators, six research nurses (equivalent to four full-time positions), and three study physicians in part-time positions (all holding a PhD and one professor). We also have a full-time biobank technician, as well as a data manager and administrative support. In addition, we are cooperating closely with Primary Investigators (PI) within most fields of paediatric medicine and also other departments treating children at Oslo University Hospital. Thus, P-CTU has the expertise, capacity, and infrastructure to conduct clinical trials on children within most medical specialties.
In 2025, the P‑CTU was involved in the conduct of 52 clinical studies, including 35 industry‑sponsored trials and 17 academic studies.
Ongoing studies in Oslo
| Prosjekt | Status | Sykehus |
|---|---|---|
| Open-label, single arm safety prospective cohort study of Dabigatran Etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years. | Pågår | |
| Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE) | Pågår | |
| A Phase I Open-Label Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids | Pågår | |
| A Multi-centre, Randomized, Placebo-controlled, Double-blind, Two-armed, Parallel Group Study To Evaluate Efficacy And Safety Of Iv Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn (Pphn) Or Hypoxic Respiratory Failure And At Risk For Pphn, With A Long Term Follow-up Investigation Of Developmental Progress 12 And 24 Months After Completion Of Study Treatment | Pågår | |
| A Multicenter Phase III Uncontrolled Open-label Trial to Evaluate Safety and Efficacy of BAY81-8973 in Children With Severe Hemophilia A Under Prophylaxis Therapy | Pågår | |
| Single Dose, Open Label, Uncontrolled, Safety Trial of Intravenous Administration of Idarucizumab to Paediatric Patients Enrolled From Ongoing Phase IIb/III Clinical Trials With Dabigatran Etexilate for the Treatment and Secondary Prevention of Venous Thromboembolism. | Pågår | |
| A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia | Pågår | |
| Expanded Treatment Protocol for Relapsed/Refractory Pediatric/Young Adult Acute Lymphoblastic Leukemia Patients to be Treated With CTL019 | Pågår | |
| Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity, and Hemostatic Efficacy of PEGylated Factor VIII (BAX 855) in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) < 6 Years With Severe Hemophilia A (FVIII < 1%) | Pågår | |
| A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) | Pågår | |
| Efficacy, Safety, and Tolerability of Fosmetpantotenate (RE-024), A Phosphopantothenate Replacement Therapy, in Pantothenate Kinase-Associated Neurodegeneration (PKAN) Patients: A Randomized, Double Blind, Placebo Controlled Study With an Open Label Extension | Pågår | |
| A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Infusion of Bezlotoxumab (MK 6072, Human Monoclonal Antibody to C. difficile Toxin B) in Children Aged 1 to <18 Years Receiving Antibacterial Drug Treatment for C. difficile Infection (MODIFY III) | Pågår | |
| Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies | Pågår | |
| Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD) | Pågår | |
| Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia | Pågår | |
| Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients (BIANCA) | Pågår | |
| Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (CASSIOPEIA) | Pågår | |
| Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 directed CART Cell Therapy | Pågår | |
| 24-month prospective, multicentre, non-interventional study to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A (A-SURE). | Pågår | |
| Randomisert, dobbeltblind fase II-studie Eluxadoline for IBS-D | Avventer | |
| Phase 3, open-label, randomized, multicenter, controlled trial to evaluate the pharmacokinetics and pharmacodynamics of edoxaban and to compare the efficacy and safety of edoxaban with standard of care anticoagulant therapy in pediatric subjects from birth to less than 18 years of age with confirmed venous thromboembolism (VTE) | Pågår | |
| Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Characterize the Efficacy, Safety, and Tolerability of 24 Weeks of Evolocumab for Low Density Lipoprotein-Cholesterol (LDL-C) Reduction, as Add-On to Diet and Lipid-Lowering Therapy, in Pediatric Subjects 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) | Pågår | |
| Open Label Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Pediatric Subjects (10 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH). (HAUSER-OLE) | Pågår | |
| An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis | Pågår | |
| A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH) | Pågår |