Klinisk forskningspost for barn, Helse Bergen HF

Klinisk forskingspost barn (KFPB) ble opprettet i 2007. På denne posten er det spesielt lagt til rette for klinisk legemiddelutprøving i tidlig fase, samt utprøving av ny teknologi.

Utstyr på KFPB:

KFPB har servicerom med ulike typer utstyr. Vi har pasientrom med sengeplass og eget toalett / bad. Pasientrommet har monitoreringsutstyr. Kjernestaben kan på dagtid benyttes til gjennomføring av prosjekt.

Kontakt oss gjerne:

Overlege Camilla Tøndel, mobil 924 68 362

Overlege Asle Hirth, mobil 917 56 917

Forskingskoordinatorer

Anita Hofstad, mobil 917 80 976

Jorunn Johanne Jacobsen Syltøy, mobil 994 18 955

Marianne Fischer, mobil 907 10 870

Maria Prestegård, mobil 410 46 342

Susanne Eidset, mobil 95 162 140

Studieoversikt, pågående og gjennomførte studier i Bergen (listen er sist oppdatert i 2019!)

Viser 25 av 53 rader

REK	Prosjekt	Status	Lenker
522497//2021-000713-17	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	ClinicalTrials.gov
2024-516822-67-00.	An Interventional Study of Infigratinib in Children With Hypochondroplasia (HCH)	Pågår	ClinicalTrials.gov
2024-513857-55-00	Extension Study of Infigratinib in Children With Achondroplasia (ACH)	Pågår	ClinicalTrials.gov
713744	Prospective Clinical Assessment Study in Children with Hypochondroplasia: ACCEL	Pågår	ClinicalTrials.gov
2022-50198-42-00	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	ClinicalTrials.gov
2014/886	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	ClinicalTrials.gov
2013/1614	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	ClinicalTrials.gov
2016/35	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	ClinicalTrials.gov
2009/2049	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	ClinicalTrials.gov
2014/1633	A Long-term Access Programme for Subjects With Severe Asthma Who Participated in a GSK-sponsored Mepolizumab Clinical Study	Ferdig	—
2015/2324	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	ClinicalTrials.gov
2013/415	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	—
2016/913	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	ClinicalTrials.gov
2017/1309	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	ClinicalTrials.gov
2019/286	Observational Evaluation of Atopic Dermatitis in Pediatric Patients (PEDISTAD)	Ferdig	ClinicalTrials.gov
2018/2169	Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia	Avsluttet	ClinicalTrials.gov
2018/1675	Screening Protocol to Determine Patient Eligibility for Inclusion in AAV Gene Therapy Clinical Trials (ECLIPSE)	Ferdig	—
2017/661	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	ClinicalTrials.gov
2017/660//2018/2167	A Phase 1, Single-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old	Ferdig	ClinicalTrials.gov
2017/2185	Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12	Ferdig	ClinicalTrials.gov
2015/927	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	ClinicalTrials.gov
2016/1179	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	ClinicalTrials.gov
2018/1527	An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis	Ferdig	ClinicalTrials.gov
30474	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	ClinicalTrials.gov
2014/1885	Atrovent in Exercise Induced Laryngeal Obstruction (EILO)	Ferdig	ClinicalTrials.gov