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An open label, multi-center roll-over study to assess long-term effect in pediatric patients treated with Tafinlar (dabrafenib) and/or Mekinist (trametinib)

This study has been transitioned to CTIS with ID 2023-509276-42-00 check the CTIS register for the current data. Primary:To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.Secondary:To assess the long-term…

Pharmacokinetics of fluconazole given orally or intravenously as prophylaxis or therapy to children and adolescents with invasive fungal infections

This study has been transitioned to CTIS with ID 2024-518305-17-01 check the CTIS register for the current data. Primary objective:• To establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years.…

Reduction of blood loss in pediatric osteotomies around the hip
- A randomized placebo-controlled trial with tranexamic acid -

This study has been transitioned to CTIS with ID 2024-516324-34-01 check the CTIS register for the current data. To evaluate (reduction of) intraoperative blood-loss with and without pre-operative TXA administration, in children undergoing a…

Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation.

This study has been transitioned to CTIS with ID 2024-511585-36-00 check the CTIS register for the current data. The key objective is to personalize tacrolimus treatment for children with a renal transplant by using dosing algorithms to calculate…

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)

This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

An open-label, single-center, exploratory study of the safety and efficacy of avalglucosidase alfa in patients with non-classic Pompe disease aged >= 5 years.

This study has been transitioned to CTIS with ID 2024-518215-18-00 check the CTIS register for the current data. To explore safety, tolerability and efficacy of avalglucosidase alfa in previously treated alglucosidase alfa late-onset Pompe disease…