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EudraCT Number: 2017-000540-18

Sponsor Protocol Number: VX16-661-114

Start Date:

Sponsor Name: Vertex Pharmaceuticals Incorporated

Full Title: Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population ...

Medical condition: Cystic Fibrosis

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10010331 - Congenital, familial and genetic disorders	10011762	Cystic fibrosis	PT

Population Age: Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: FR (Completed) DE (Completed)

Trial results: View results

EudraCT Number: 2021-004057-23

Sponsor Protocol Number: 2021-12945

Start Date:

Sponsor Name: Radboudumc

Full Title: Ethanol submandibular duct ligation for drooling in children with neurodisabilities

Medical condition: Drooling or sialorrhea

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Adolescents, Under 18

Gender: Male, Female

Trial protocol: NL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2018-002981-37

Sponsor Protocol Number: YKP3089C033

Start Date:

Sponsor Name: SK Life Science, Inc.

Full Title: A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures

Medical condition: Primary Generalized Tonic-Clonic Seizures

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	100000004852	10018101	Generalised tonic-clonic seizures	HLT

Population Age: Adolescents, Under 18, Adults, Elderly

Gender: Male, Female

Trial protocol: SK (Ongoing) PL (Ongoing) CZ (Completed) BG (Completed)

Trial results: (No results available)

EudraCT Number: 2021-000891-12

Sponsor Protocol Number: 212149

Start Date:

Sponsor Name: GlaxoSmithKline Biologicals

Full Title: A staged Phase I/II observer-blind, randomised, controlled, multi-country study to evaluate the safety, reactogenicity, and immune responses to the GVGH altSonflex1-2-3 vaccine against S. sonnei an...

Medical condition: Prophylaxis for Shigellosis induced by Shigella sonnei, Shigella flexneri 1b, Shigella flexneri 2a and Shigella flexneri 3a.

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10021881 - Infections and infestations	10040550	Shigella infections	HLT
	20.0	10021881 - Infections and infestations	10054178	Shigella infection	PT
	20.0	10021881 - Infections and infestations	10040542	Shigella	LLT
	20.0	10021881 - Infections and infestations	10040547	Shigella flexneri	LLT
20.0	10021881 - Infections and infestations	10040551	Shigella sonnei	LLT
20.1	10021881 - Infections and infestations	10004016	Bacterial diarrhoea	PT
20.0	10017947 - Gastrointestinal disorders	10012735	Diarrhoea	PT

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

Gender: Male, Female

Trial protocol: BE (Ongoing)

Trial results: (No results available)

EudraCT Number: 2008-002774-34

Sponsor Protocol Number: A2581172

Start Date:

Sponsor Name: Pfizer Inc,235 East 42nd Street,New York,NY 10017

Full Title: A 8-WEEK, OPEN-LABEL, PHASE 1 STUDY TO EVALUATE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF ATORVASTATIN IN CHILDREN AND ADOLESCENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

Medical condition: HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

Disease:	Version	SOC Term	Classification Code	Term	Level
	9.1		10057079	Heterozygous familial hypercholesterolemia	LLT

Population Age: Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: NL (Not Authorised) Outside EU/EEA

Trial results: View results

EudraCT Number: 2009-009597-27

Sponsor Protocol Number: BAY86-4875/91743

Start Date:

Sponsor Name: Bayer Health Care AG (study performed by Bayer Schering Pharma AG)

Full Title: An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1...

Medical condition: Patients with histologically confirmed breast cancer referred to MRM prior to surgery after XRM.

Disease:	Version	SOC Term	Classification Code	Term	Level
	12.0		10012992	Digital mammography	LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Completed) FI (Completed) IT (Completed)

Trial results: View results

EudraCT Number: 2010-019962-10

Sponsor Protocol Number: P1-SAF301

Start Date:

Sponsor Name: SANFILIPPO Therapeutics SAS

Full Title: AN OPEN-LABEL, SINGLE ARM, MONOCENTRIC, PHASE I/II CLINICAL STUDY OF INTRACEREBRAL ADMINISTRATION OF ADENO-ASSOCIATED VIRAL VECTORS SEROTYPE 10 CARRYING THE HUMAN SGSH AND SUMF1 cDNAS FOR THE TREAT...

Medical condition: Sanfilippo type A syndrome (also named Mucopolysaccharidosis Type A)

Disease:	Version	SOC Term	Classification Code	Term	Level
	12.1		10056918	Sanfilippo's syndrome	LLT

Population Age: Infants and toddlers, Children, Under 18

Gender: Male, Female

Trial protocol: FR (Completed)

Trial results: (No results available)

EudraCT Number: 2018-001686-17

Sponsor Protocol Number: P170925J

Start Date:

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

Full Title:

Medical condition: Patients older than 15 years with hematologic or pulmonary lesions of telomeropathies.

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10010331 - Congenital, familial and genetic disorders	10062759	Congenital dyskeratosis	PT

Population Age: Adolescents, Under 18

Gender: Male, Female

Trial protocol: FR (Ongoing)

Trial results: (No results available)

EudraCT Number: 2016-002526-36

Sponsor Protocol Number: PVO-1A-204

Start Date:

Sponsor Name: Clementia Pharmaceuticals Inc.

Full Title: A Phase 2, Open-Label, Efficacy and Safety Study of an RARγ-Specific Agonist (Palovarotene) to Prevent Heterotopic Ossification in Subjects with Fibrodysplasia Ossificans Progressiva (FOP)

Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...

Disease:	Version	SOC Term	Classification Code	Term	Level
	19.0	10010331 - Congenital, familial and genetic disorders	10068715	Fibrodysplasia ossificans progressiva	PT

Population Age: Children, Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: FR (Completed)

Trial results: (No results available)

EudraCT Number: 2021-005314-34

Sponsor Protocol Number: SRK-015-003

Start Date:

Sponsor Name: Scholar Rock, Inc.

Full Title: Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or ...

Medical condition: Spinal Muscular Atrophy (SMA)

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.1	100000004850	10041583	Spinal muscular atrophy, unspecified	LLT

Population Age: Children, Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: BE (Ongoing) DE (Ongoing) ES (Ongoing) NL (Ongoing) PL (Ongoing)

Trial results: (No results available)

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