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EudraCT Number: 2010-022785-27

Sponsor Protocol Number: Q4882g

Start Date:

Sponsor Name: Genentech, Inc.

Full Title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING, PLACEBO-CONTROLLED STUDY TO Evaluate the efficacy, RESPONSE DURATION and safety OF XOLAIR (OMALIZUMAB) IN PATIENTS WITH CHRONIC IDI...

Medical condition: CHRONIC IDIOPATHIC URTICARIA (CIU)

Disease:	Version	SOC Term	Classification Code	Term	Level
	12.1		10021247	Idiopathic urticaria	LLT

Population Age: Adolescents, Under 18, Adults, Elderly

Gender: Male, Female

Trial protocol: FR (Ongoing) DE (Completed) DK (Completed) IT (Completed) ES (Ongoing)

Trial results: View results

EudraCT Number: 2014-004806-14

Sponsor Protocol Number: TKS-2014-001

Start Date:

Sponsor Name: Therakos, Inc.

Full Title: Single-Arm Study to Assess the Efficacy of UVADEX® (methoxsalen) Sterile Solution in Conjunction with the THERAKOS® CELLEX® Photopheresis System in Pediatric Patients with Steroid-Refractory Acute ...

Medical condition: Acute graft-versus-host disease (aGvHD)

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.1	10021428 - Immune system disorders	10018651	Graft versus host disease	PT

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

Gender: Male, Female

Trial protocol: DE (Completed) HU (Completed) GB (Completed) IT (Completed) ES (Completed) AT (Completed)

Trial results: View results

EudraCT Number: 2018-004878-99

Sponsor Protocol Number: INCB84344-102

Start Date:

Sponsor Name: Incyte Biosciences International Sàrl

Full Title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants

Medical condition: Recurrent or Refractory Leukemias, Lymphomas, and Solid Tumors

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10000830	Acute leukaemia	PT
	21.1	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10000880	Acute myeloid leukaemia	PT
	21.1	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10009013	Chronic myeloid leukaemia	PT
	21.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10028549	Myeloid leukaemia	PT
21.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10028553	Myeloid leukaemia, chronic	LLT
21.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10028552	Myeloid leukaemia, acute	LLT
20.1	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10027655	Miscellaneous and site unspecified neoplasms malignant and unspecified	HLGT

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

Gender: Male, Female

Trial protocol: SE (Trial now transitioned) BE (Trial now transitioned) FR (Ongoing) ES (Ongoing) DE (Ongoing) NL (Trial now transitioned) GB (GB - no longer in EU/EEA) IT (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-006597-23

Sponsor Protocol Number: UX143-CL301

Start Date:

Sponsor Name: Ultragenyx Pharmaceutical Inc.

Full Title: A Randomized, Double-Blind, Placebo-controlled, Phase 2/3 Study to Assess the Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta.

Medical condition: Osteogenesis imperfecta (OI)

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10010331 - Congenital, familial and genetic disorders	10031243	Osteogenesis imperfecta	PT

Population Age: Children, Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: FR (Ongoing) DK (Prematurely Ended) DE (Ongoing) IT (Ongoing) PL (Ongoing) PT (Ongoing)

Trial results: (No results available)

EudraCT Number: 2017-004851-22

Sponsor Protocol Number: B7451015

Start Date:

Sponsor Name: Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001, U.S.A.

Full Title: A phase 3 multi-center, long-term extension study investigating the efficacy and safety of Abrocitinib, with or without topical medications, administered to subjects aged 12 years and older with m...

Medical condition: Moderate to severe atopic dermatitis

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.1	100000004858	10003639	Atopic dermatitis	LLT

Population Age: Adolescents, Under 18, Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Ongoing) GB (GB - no longer in EU/EEA) CZ (Ongoing) HU (Ongoing) PL (Ongoing) NL (Ongoing) BG (Ongoing) BE (Ongoing) LV (Ongoing) ES (Ongoing) SK (Ongoing) FR (Completed) AT (Completed) SE (Prematurely Ended) IT (Ongoing) FI (Ongoing) RO (Ongoing)

Trial results: (No results available)

EudraCT Number: 2018-004828-11

Sponsor Protocol Number: RECHMPL18_0038_prom_7574

Start Date:

Sponsor Name: University Hospital of Montpellier

Full Title: Phosphodiesterase-type 5 inhibitors in adult and adolescent patients with univentricular heart disease: a multi-center, randomized, double blind phase III study

Medical condition: adult and adolescent patients with univentricular heart diseases and pulmonary arterial pressure

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: FR (Ongoing)

Trial results: (No results available)

EudraCT Number: 2017-003220-78

Sponsor Protocol Number: I8B-MC-ITSA

Start Date:

Sponsor Name: Eli Lilly and Company

Full Title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults with Type 1 Diabetes Mellitus

Medical condition: Diabetes Mellitus, Type 1

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10027433 - Metabolism and nutrition disorders	10012601	Diabetes mellitus	PT

Population Age: Children, Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: DE (Completed)

Trial results: View results

EudraCT Number: 2014-002442-45

Sponsor Protocol Number: AXAFA-AFNET5

Start Date:

Sponsor Name: Kompetenznetz Vorhofflimmern e.V. [Atrial Fibrillation NETwork (AFNET)]

Full Title: Anticoagulation using the direct factor Xa inhibitor apixaban during Atrial Fibrillation catheter Ablation: Comparison to vitamin K antagonist therapy.

Medical condition: Atrial fibrillation catheter ablation

Disease:	Version	SOC Term	Classification Code	Term	Level
	19.0	10007541 - Cardiac disorders	10003658	Atrial fibrillation	PT
	19.0	10007541 - Cardiac disorders	10071667	Persistent atrial fibrillation	LLT
	19.0	10007541 - Cardiac disorders	10003661	Atrial fibrillation paroxysmal	LLT
	19.0	10007541 - Cardiac disorders	10066582	Recurrent atrial fibrillation	LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Completed) BE (Completed) DK (Completed) GB (Completed) NL (Completed) ES (Completed) AT (Completed)

Trial results: (No results available)

EudraCT Number: 2006-006907-35

Sponsor Protocol Number: SP915

Start Date:

Sponsor Name: Schwarz Biosciences GmbH

Full Title: Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTI...

Medical condition: Parkinson's disease

Disease:	Version	SOC Term	Classification Code	Term	Level
	9.1		10061536	Parkinson's disease	LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Prematurely Ended) FI (Completed) ES (Completed) HU (Completed) IT (Completed) GB (Completed) AT (Prematurely Ended)

Trial results: View results

EudraCT Number: 2005-005641-19

Sponsor Protocol Number: ENG K001 GF / EC 406

Start Date:

Sponsor Name: Takeda Pharma GmbH

Full Title: 3 Months, Open-Label, Parallel-Group Study of the Pharmacodynamics, Pharmacokinetics and Safety of TAP-144SR 1-month Depot Gelatin-Free vs. Gelatin-Containing Formulation in Female Patients with Ut...

Medical condition: Uterine fibroids (Uterus myomatosus)

Disease:	Version	SOC Term	Classification Code	Term	Level
	8.0		10046784		LLT

Population Age: Adults

Gender: Female

Trial protocol: DE (Completed)

Trial results: View results

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