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EudraCT Number: 2010-019267-11

Sponsor Protocol Number: MA-PA25CF10-01

Start Date:

Sponsor Name: Axcan Pharma Inc.

Full Title: AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WI...

Medical condition: Correction of steathorrea associated with chronic exocrine pancreatic insufficiency in cystic fibrosis

Disease:	Version	SOC Term	Classification Code	Term	Level
	13.1	10017947 - Gastrointestinal disorders	10033628	Pancreatic insufficiency	PT
	13.1	10017947 - Gastrointestinal disorders	10041968	Steatorrhea	LLT
	13.1	10010331 - Congenital, familial and genetic disorders	10011762	Cystic fibrosis	PT

Population Age: Children, Adolescents, Under 18, Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Completed)

Trial results: View results

EudraCT Number: 2021-004600-17

Sponsor Protocol Number: T21

Start Date:

Sponsor Name: Royal College of Surgeons in Ireland

Full Title: The use of Sildenafil in Neonates with Down Syndrome to Reduce Pulmonary Vascular Resistance.

Medical condition: to assess the impact of oral sildenafil administration on echocardiography measurements of pulmonary vascular resistance in neonates with Down Syndrome without Congenital Heart Disease.

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.1	10022891 - Investigations	10067285	Vascular resistance pulmonary increased	PT

Population Age: Preterm newborn infants, Under 18

Gender: Male, Female

Trial protocol: IE (Prematurely Ended)

Trial results: (No results available)

EudraCT Number: 2015-002734-41

Sponsor Protocol Number: P091205

Start Date:

Sponsor Name: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Full Title:

Medical condition:

Disease:	Version	SOC Term	Classification Code	Term	Level
	18.0	100000004864	10000845	Acute lymphoblastic leukemia	LLT

Population Age: Infants and toddlers, Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: FR (Ongoing)

Trial results: (No results available)

EudraCT Number: 2020-005992-10

Sponsor Protocol Number: 156-201-00307

Start Date:

Sponsor Name: Otsuka Pharmaceutical Development & Commercialization, Inc.

Full Title: A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 18 years of Age with Autosomal Recessive Polycystic Kidne...

Medical condition: Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	100000004850	10036047	Polycystic kidney, autosomal recessive	LLT

Population Age: Infants and toddlers, Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: DE (Ongoing) ES (Ongoing) BE (Trial now transitioned) PL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2014-001089-90

Sponsor Protocol Number: OTT329/402

Start Date:

Sponsor Name: Oriel Therapeutics, a Sandoz Company

Full Title: Study to Test the Product Robustness of a Dry Powder Inhalation Device When Used in Normal Clinical Practice with Young Asthma Patients

Medical condition: The study is designed to demonstrate the robustness of the OT329 Solis product. The primary endpoint that is derived from the dataset will be product robustness after approximately 21-24 days of ...

Disease:	Version	SOC Term	Classification Code	Term	Level
	17.1	10038738 - Respiratory, thoracic and mediastinal disorders	10038738	Respiratory, thoracic and mediastinal disorders	SOC
	17.1	10038738 - Respiratory, thoracic and mediastinal disorders	10003561	Asthma, unspecified	LLT

Population Age: Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: GB (GB - no longer in EU/EEA)

Trial results: (No results available)

EudraCT Number: 2019-003559-12

Sponsor Protocol Number: INCIPIT

Start Date:

Sponsor Name: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Full Title: Prospective, open-label, non-randomized, single-arm, dose titration study to investigate the efficacy and safety of IncobotulinumtoxinA in children deemed to require a total body dose up to 22U/kg ...

Medical condition: Multifocal spasticity of the upper and lower limb due to cerebral palsy

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10029205 - Nervous system disorders	10028335	Muscle spasticity	PT
	20.0	100000004850	10033560	Palsy cerebral	LLT

Population Age: Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: IT (Ongoing)

Trial results: (No results available)

EudraCT Number: 2012-001829-27

Sponsor Protocol Number: AC-052-392

Start Date:

Sponsor Name: Actelion Pharmaceuticals Ltd.

Full Title: Multi-center non-drug-interventional extension study to assess long-term safety and effects on growth in patients who received bosentan or placebo as adjunctive therapy to inhaled nitric oxide for ...

Medical condition: Persistent Pulmonary Hypertension of the Newborn (PPHN)

Disease:	Version	SOC Term	Classification Code	Term	Level
	14.1	100000004850	10053592	Newborn persistent pulmonary hypertension	LLT

Population Age: Preterm newborn infants, Newborns, Under 18

Gender: Male, Female

Trial protocol: BE (Ongoing) CZ (Completed) PL (Completed) FR (Ongoing)

Trial results: View results

EudraCT Number: 2012-000810-12

Sponsor Protocol Number: IntReALL-HR-2010

Start Date:

Sponsor Name: Charité - Universitätsmedizin Berlin

Full Title: IntReALL HR 2010 International Study for Treatment of High Risk Childhood Relapsed ALL 2010

Medical condition: Acute lymphoblastic leukemia (ALL)

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: SE (Ongoing) DE (Ongoing) DK (Completed) PT (Ongoing) AT (Ongoing) NO (Ongoing) FI (Ongoing) FR (Ongoing) CZ (Ongoing) BE (Ongoing) ES (Ongoing) NL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2022-000757-93

Sponsor Protocol Number: ISIS721744-CS7

Start Date:

Sponsor Name: IONIS PHARMACEUTICALS, INC.

Full Title: An Open-Label, Long Term Safety and Efficacy Study of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

Medical condition: Hereditary Angioedema (HAE)

Disease:	Version	SOC Term	Classification Code	Term	Level
	23.1	10010331 - Congenital, familial and genetic disorders	10019860	Hereditary angioedema	PT

Population Age: Adolescents, Under 18, Adults, Elderly

Gender: Male, Female

Trial protocol: FR (Ongoing) ES (Ongoing) BE (Ongoing) DE (Ongoing) NL (Ongoing) DK (Completed) PL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2022-000369-42

Sponsor Protocol Number: WA43380

Start Date:

Sponsor Name: F. Hoffman-La Roche Ltd.

Full Title: A PHASE III, INTERNATIONAL, MULTICENTER, RANDOMISED OPEN LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB VERSUS MMF IN PATIENTS WITH CHILDHOOD ONSET IDIOPATHIC NEPHROTIC SYNDROME

Medical condition: Childhood Onset Idiopathic Nephrotic Syndrome

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.1	10038359 - Renal and urinary disorders	10029164	Nephrotic syndrome	PT

Population Age: Children, Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: BE (Trial now transitioned) DE (Trial now transitioned) PL (Ongoing) ES (Ongoing) FR (Ongoing) IT (Ongoing)

Trial results: (No results available)

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