ICH GCP - EU Clinical trials Registry

EudraCT Number: 2023-000150-20

Sponsor Protocol Number: 1

Start Date: 2023-03-22

Sponsor Name: Bispebjerg-Frederiksberg Hospital

Full Title: The effect of exercise on pharmacodynamics and pharmacokinetics of a single dose of unfractionated heparin: A randomized, controlled, cross-over study

Medical condition: Unfractionated heparin is used for the prevention and treatment of deep vein thrombosis and complications hereof

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.1	10047065 - Vascular disorders	10051055	Deep vein thrombosis	PT

Population Age: Adults

Gender: Male

Trial protocol: DK (Ongoing)

Trial results: (No results available)

EudraCT Number: 2022-003885-19

Sponsor Protocol Number: NOT-APPLICABLE-HUFA

Start Date: 2023-03-15

Sponsor Name:

Full Title: ECOGUIDED GENICULAR NERVE BLOCK IN PATIENTS WITH KNEE OSTEOARTHRITIS BY LOCAL ANESTHETIC OR BY COMBINATION OF LOCAL ANESTHETIC AND CORTICOID: PLACEBO-CONTROLLED RANDOMIZED BLIND CLINICAL TRIAL

Medical condition: KNEE OSTEOARTHRITIS

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: ES (Ongoing)

Trial results: (No results available)

EudraCT Number: 2022-002593-89

Sponsor Protocol Number: TV48574-IMM-20038

Start Date: 2023-03-15

Sponsor Name: Teva Branded Pharmaceutical Products R&D, Inc.

Full Title: A 24-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability of TEV-48574 in Adult Patients with Moderate to Severe Ulcera...

Medical condition: Moderate to severe Ulcerative colitis or moderate to severe Crohn's disease

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.1	100000004856	10045365	Ulcerative colitis	LLT
	20.0	100000004856	10011400	Crohn's colitis	LLT

Population Age: Adults, Elderly

Gender: Male, Female

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

Trial results: (No results available)

EudraCT Number: 2021-004890-29

Sponsor Protocol Number: FIT-PIV

Start Date: 2023-03-09

Sponsor Name: Elgan Pharma Ltd

Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.1	100000004856	10025479	Malabsorption syndrome	LLT

Population Age: Preterm newborn infants, Under 18

Gender: Male, Female

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

Trial results: (No results available)

EudraCT Number: 2021-005066-17

Sponsor Protocol Number: CADPT09A12201

Start Date: 2023-03-07

Sponsor Name: Novartis Pharma AG

Full Title: A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants w...

Medical condition: Idiopathic pulmonary fibrosis

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.1	10038738 - Respiratory, thoracic and mediastinal disorders	10021240	Idiopathic pulmonary fibrosis	PT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Ongoing)

Trial results: (No results available)

EudraCT Number: 2022-001384-27

Sponsor Protocol Number: 2022-031

Start Date: 2023-02-28

Sponsor Name: Franciscus Gasthuis & Vlietland

Full Title: Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial

Medical condition: Morbid obesity

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.1	100000004865	10059610	Obesity surgery	LLT
	21.0	100000004861	10027966	Morbid obesity	LLT
	21.1	100000004865	10068900	Bariatric surgery	LLT

Population Age: Adults

Gender: Male, Female

Trial protocol: NL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2022-002833-33

Sponsor Protocol Number: APL2-C3G-314

Start Date: 2023-02-22

Sponsor Name: Apellis Pharmaceuticals, Inc.

Full Title: An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferati...

Medical condition: C3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN)

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10038359 - Renal and urinary disorders	10038359	Renal and urinary disorders	SOC
	20.0	10038359 - Renal and urinary disorders	10077827	C3 glomerulopathy	PT
	21.1	10038359 - Renal and urinary disorders	10027168	Membranoproliferative glomerulonephritis	LLT

Population Age: Adolescents, Under 18, Adults, Elderly

Gender: Male, Female

Trial protocol: ES (Ongoing) CZ (Ongoing)

Trial results: (No results available)

EudraCT Number: 2021-003314-39

Sponsor Protocol Number: 78934804CRD2001

Start Date: 2023-02-21

Sponsor Name: Janssen-Cilag International NV

Full Title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Gusel...

Medical condition: Moderately to Severely Active Crohn's Disease

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10017947 - Gastrointestinal disorders	10011401	Crohn's disease	PT

Population Age: Adults

Gender: Male, Female

Trial protocol: DE (Ongoing) ES (Ongoing) HU (Ongoing) NL (Ongoing) CZ (Ongoing) PT (Ongoing) BG (Ongoing) NO (Ongoing) SI (Ongoing) SE (Ongoing) DK (Ongoing)

Trial results: (No results available)

EudraCT Number: 2022-002680-30

Sponsor Protocol Number: D926XC00001

Start Date: 2023-02-20

Sponsor Name: AstraZeneca AB

Full Title: A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Can...

Medical condition: Stage I-III triple-negative breast cancer with residual invasive disease after neoadjuvant therapy.

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10075566	Triple negative breast cancer	PT

Population Age: Adults, Elderly

Gender: Male, Female

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

Trial results: (No results available)

EudraCT Number: 2021-005528-39

Sponsor Protocol Number: 78934804UCO2001

Start Date: 2023-02-16

Sponsor Name: Janssen-Cilag International NV

Full Title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Gusel...

Medical condition: Moderately to Severely Active Ulcerative Colitis

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.1	100000004856	10045365	Ulcerative colitis	LLT

Population Age: Adults

Gender: Male, Female

Trial protocol: DE (Ongoing) ES (Ongoing) HU (Ongoing) CZ (Ongoing) NL (Ongoing) SK (Ongoing) BG (Ongoing) NO (Ongoing) DK (Ongoing) SE (Ongoing) SI (Ongoing)

Trial results: (No results available)

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