Haukeland University Hospital
The Pediatric Clinical Trials Unit at Haukeland University Hospital was established in 2007 as the first clinical research facility dedicated pediatric drug clinical trials in Northern Europe. During almost two decades the unit has had a high number of drug trials (>70) on a wide specter of diseases affecting children. Monitoring from many different international sponsors/CROs, audits and inspections have given the unit valuable knowledge, and the team is using this experience assisting many dedicated researchers and sponsors.
Study nurses Maria Prestegård, Anita Hofstad, Marianne Fischer, Susanne Eidset and Jorunn Syltøy, medical lead Camilla Tøndel
Ongoing studies in Bergen
Viser 25 av 53 rader
| Prosjekt | Status | Sykehus |
|---|---|---|
| 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 | Pågår | |
| An Interventional Study of Infigratinib in Children With Hypochondroplasia (HCH) | Pågår | |
| Extension Study of Infigratinib in Children With Achondroplasia (ACH) | Pågår | |
| Prospective Clinical Assessment Study in Children with Hypochondroplasia: ACCEL | Pågår | |
| 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 | Pågår | |
| 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 | Ferdig | |
| Open-label, randomized, parallel-group, active-controlled, multi-centre, non-inferiority study of dabigatran etexilate versus standard of care for venous thromboembolism treatment in children from birth to less than 18 years of age: The DIVERSITY study | Ferdig | |
| An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC) (Crocodile Study), | Ferdig | |
| Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine | Ferdig | |
| A Long-term Access Programme for Subjects With Severe Asthma Who Participated in a GSK-sponsored Mepolizumab Clinical Study | Ferdig | |
| 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 | Ferdig | |
| 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 | Ferdig | |
| 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. | Ferdig | |
| 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) | Ferdig | |
| Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD) | Ferdig | |
| Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia | Avsluttet | |
| Screening Protocol to Determine Patient Eligibility for Inclusion in AAV Gene Therapy Clinical Trials (ECLIPSE) | Ferdig | |
| A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Infections | Ferdig | |
| A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old | Ferdig | |
| Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 | Ferdig | |
| 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) | Ferdig | |
| 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) | Ferdig | |
| An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis | Ferdig | |
| A randomized, open-label, active comparator, 2-arm, prospective study to assess the glycosphingolipid clearance and clinical benefits of agalsidase beta (Fabrazyme®) in male patients with classic Fabry Disease Switching From Agalsidase Alfa (Replagal®) | Pågår | |
| Atrovent in Exercise Induced Laryngeal Obstruction (EILO) | Ferdig |
Contact:
Medical lead/professor of pediatrics Camilla Tøndel
✉️Camilla.tondel@helse-bergen.no
📞+4792468362