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.
— This page is under construction. The following list of ongoing studies is therefore not yet complete —
Ongoing studies in Oslo
| Study | Status | Site |
|---|---|---|
| Open-label study investigating efficacy, safety and pharmacokinetics of concizumab prophylaxis in children below 12 years with haemophilia A or B with or without inhibitors | Open | |
| A phase 3 randomized, open-label induction, double-blind maintenance, parallel-group, multicenter protocol to evaluate the efficacy, safety and pharmacokinetics of Guselkumab in pediatric participants with moderately to severely active ulcerative colitis (Quasar Jr) | Open | |
| A multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of filgotinib, with single arm induction and maintenance, in pediatric subjects (8 to <18 years of age) with moderately to severely active ulcerative colitis (Galapeduca). | Open | |
| Master protocol: A phase 3, multicenter, randomized, platform study of p19 inhibition of the IL-23 pathway to establich efficacy in pediatric Crohn`s disease. A study of Guselkumab in pediatric participants with moderately to severely active Crohn`s disease (Macaroni). | Open | |
| Master protocol: A phase 3, multicenter, randomized, platform study of p19 inhibition of the IL-23 pathway to establich efficacy in pediatric Crohn`s disease. ISA title: A phase 3, multicenter, randomized, clinical study to evaluate Mirikizumab in pediatric Crohn`s diseases (Macaroni). | Open | |
| A phase 3, open-label study evaluating the long-term safety and efficacy of VX-121/TEZ/D-IVA combination therapy in subjects with cystic fibrosis | Open | |
| A Study to Investigate the Course of Synovial Hypertrophy in Patients with haemophilia A on Efanesoctocog Alfa prophylaxis | Open | |
| A phase 3b open-label, multicenter study evaluating physical activity and joint health in previously treated patients ≥12 years of age with severe haemophilia A treated with intravenous recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN; efanesoctocog alfa) for 24 months | Open | |
| A multinational, prospective, open-label, roll-over study (LIBERTY) to provide post-trial access to treatment for patients with severe haemophilia A who have completed a previous trial with efanesoctocog alfa | Open | |
| Müdem Treatment of lnhibitor-PositiVe PATiEnts with Haemophilia A -An International Low-lnterventional Pragmatic lnvestigator lnitiated Trial | Open | |
| A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML | Open | |
| A 12-month, interventional, open-label, phase 4 study in Europe to investigate the course of synovial hypertrophy as detected by joint ultrasound and MRI in patients with haemophilia A on efanesoctocog alfa prophylaxis. | Open | |
| A Study to Investigate the Pharmacokinetics and Safety of Risdiplam in Infants With Spinal Muscular Atrophy (PUPFISH) | Open | |
| EPIK-P2: A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS) | Open | |
| Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A (HEM-POWR) | Open | |
| A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia | Open | |
| Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH) | Open | |
| An Interventional Study of Infigratinib in Children With Hypochondroplasia (HCH) | Open | |
| A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL | Open | |
| Extension Study of Infigratinib in Children With Achondroplasia (ACH) | Open | |
| CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients (CHIP-AML22/Q) | Open | |
| Prospective Clinical Assessment Study in Children with Hypochondroplasia: ACCEL | Open | |
| A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial, evaluating Safety, Tolerability, and Efficacy of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Infants (0 to <2 years of age) with Achondroplasia followed by an Open Label Extension (OLE) period. | Open | |
| LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy | Open | |
| A Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants with Chronic Kidney Disease | Open |