ICH GCP - EU Clinical trials Registry

EudraCT Number: 2021-005504-36

Sponsor Protocol Number: ABNCoV2-03

Start Date: 2022-09-19

Sponsor Name: Bavarian Nordic A/S

Full Title: Evaluation of the Immunogenicity, Safety, and Tolerability of a Single Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2: a Phase 3 Trial in Two Parts—Randomized, Doubl...

Medical condition: COVID-19 disease

Disease:	Version	SOC Term	Classification Code	Term	Level
	23.1	10042613 - Surgical and medical procedures	10084457	COVID-19 immunisation	PT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DK (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-005573-12

Sponsor Protocol Number: LP0162-1335

Start Date: 2022-09-02

Sponsor Name: LEO Pharma A/S

Full Title: A single (assessor) blinded, randomised, parallel-group, monotherapy trial to evaluate the pharmacokinetic and safety of tralokinumab in children (age 2 to

Medical condition: Atopic dermatitis

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

Population Age: Children, Under 18

Gender: Male, Female

Trial protocol: CZ (Ongoing) NL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-005178-25

Sponsor Protocol Number: 216152

Start Date: 2022-08-22

Sponsor Name: GlaxoSmithKline Biologicals SA

Full Title: A Phase 1/2a, observer-blind, randomized, controlled, two-stage, multi-country study to evaluate the safety, reactogenicity, and immune response of the trivalent vaccine against invasive nontyphoid...

Medical condition: Healthy volunteers (prevention of invasive nontyphoidal Salmonella disease and typhoid fever)

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Adults

Gender: Male, Female

Trial protocol: BE (Ongoing)

Trial results: (No results available)

EudraCT Number: 2019-004183-21

Sponsor Protocol Number: IP-001-18

Start Date: 2022-08-19

Sponsor Name: Iperboreal Pharma Srl

Full Title: A Study to Evaluate the EffIcacy and Safety of XyloCore, a Glucose Sparing Experimental Solution, for Peritoneal Dialysis

Medical condition: End-Stage Renal Disease (ESRD)

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.0	10038359 - Renal and urinary disorders	10077512	End stage renal disease	PT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Ongoing) DK (Ongoing) ES (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-004979-14

Sponsor Protocol Number: AR-320-003

Start Date: 2022-08-18

Sponsor Name: Aridis Pharmaceuticals, Inc.

Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention o...

Medical condition: Prevention of nosocomial pneumonia

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.1	100000004862	10052596	Nosocomial pneumonia	LLT

Population Age: Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: ES (Ongoing) FR (Ongoing) BE (Ongoing) NL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-005713-13

Sponsor Protocol Number: 21102

Start Date: 2022-08-16

Sponsor Name: ACELYRIN, INC.

Full Title: A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa

Medical condition: Hidradenitis Suppurativa

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	100000004858	10020041	Hidradenitis suppurativa	LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Ongoing) ES (Ongoing) HU (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-006709-31

Sponsor Protocol Number: COAV101B12302

Start Date: 2022-08-12

Sponsor Name: Novartis Pharma AG

Full Title: Phase IIIb, open-label, single-arm, multi-center study to evaluate the safety, tolerability and efficacy of OAV101 administered intrathecally (1.2 x 1014 vector genomes) to participants 2 to 12 yea...

Medical condition: Spinal Muscular Atrophy

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.1	10010331 - Congenital, familial and genetic disorders	10041582	Spinal muscular atrophy	PT

Population Age: Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: NL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-005029-26

Sponsor Protocol Number: KF7039-01

Start Date: 2022-08-08

Sponsor Name: Grünenthal GmbH

Full Title: A randomized, double-blind, placebo-controlled, Phase III trial to evaluate the efficacy and safety of intra-articular injections of RTX-GRT7039 in adult subjects with pain associated with osteoart...

Medical condition: Moderate to severe pain associated with osteoarthritis of the knee

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.1	100000004859	10023476	Knee osteoarthritis	LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Ongoing) NL (Ongoing) CZ (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-002629-95

Sponsor Protocol Number: 170188

Start Date: 2022-08-02

Sponsor Name: Surgical department, Aalborg University Hospital

Full Title: Cefuroxime and Piperacillin Concentrations in the Biliary System

Medical condition: Infection in the biliary system such as cholecystitis and cholangitis both as acute infections and post-operative infections.

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	100000004871	10008618	Cholecystitis chronic NOS	LLT
	20.0	100000004871	10008615	Cholecystitis acute NOS	LLT
	20.0	100000004871	10008619	Cholecystitis NOS	LLT
	20.0	100000004871	10004638	Bile duct stone with cholecystitis	LLT
20.0	100000004871	10007004	Calculus of gallbladder with acute cholecystitis	LLT
20.0	100000004871	10006995	Calculus of bile duct with acute cholecystitis	LLT
20.0	100000004871	10008606	Cholangitis acute NOS	LLT
20.0	100000004871	10008608	Cholangitis NOS	LLT
20.0	100000004871	10008607	Cholangitis chronic NOS	LLT
20.1	100000004862	10056952	Septic cholangitis	LLT
23.0	100000004862	10083504	Acute obstructive suppurative cholangitis	LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DK (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-006868-24

Sponsor Protocol Number: UMCN-AKF-21.05

Start Date: 2022-08-02

Sponsor Name: Radboud university medical centre

Full Title: Pharmacokinetics of fluconazole given orally or intravenously as prophylaxis or therapy to children and adolescents with invasive fungal infections (FOCUS)

Medical condition: Invasive fungal disease

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10021881 - Infections and infestations	10017533	Fungal infection	PT

Population Age: Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: NL (Ongoing)

Trial results: (No results available)

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