Newnorm

( DrugBank: - / KEGG DRUG: - )

1 disease

ID	Disease name (Link within this page)	Number of trials
65	Primary immunodeficiency	5

65. Primary immunodeficiency

Clinical trials : 500 / Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 217

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Showing 1 to 5 of 5 trials

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2020-004734-37-HU (EUCTR)	24/01/2023	17/11/2022	Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Imm ...	Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, eff ...	Primary Immunodeficiency Diseases MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: ...	Product Name: Newnorm INN or Proposed INN: Newnorm Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN ...	Octapharma Pharmazeutika Prod.Ges.m.b.H	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 1;Phase 3	United States;Hungary;Slovakia;Poland;Ukraine;Germany;Netherlands;Italy
2	EUCTR2020-004734-37-DE (EUCTR)	14/12/2021	31/05/2021	Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, eff ...	Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, eff ...	Primary Immunodeficiency Diseases MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: ...	Product Name: Newnorm INN or Proposed INN: Newnorm Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN ...	Octapharma Pharmazeutika Prod.Ges.m.b.H	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 1;Phase 3	United States;Czechia;Slovakia;Poland;Ukraine;Russian Federation;Germany
3	NCT04640142 (ClinicalTrials.gov)	August 4, 2021	17/11/2020	Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Imm ...	Prospective, Open-label, Single-arm, Multicentre Phase 3 Study to Evaluate the Pharmacokinetics, Eff ...	Primary Immune Deficiency	Biological: Newnorm	Octapharma	NULL	Recruiting	2 Years	75 Years	All	50	Phase 3	United States;Germany;Hungary;Italy;Poland;Slovakia;Ukraine
4	EUCTR2020-004734-37-PL (EUCTR)		16/06/2021	Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Imm ...	Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, eff ...	Primary Immunodeficiency Diseases MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: ...	Product Name: Newnorm INN or Proposed INN: Newnorm Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN ...	Octapharma Pharmazeutika Prod.Ges.m.b.H	NULL	NA			Female: yes Male: yes	50	Phase 1;Phase 3	United States;Czechia;Slovakia;Poland;Ukraine;Russian Federation;Germany
5	EUCTR2020-004734-37-SK (EUCTR)		02/06/2021	Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Imm ...	Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, eff ...	Primary Immunodeficiency Diseases MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: ...	Product Name: Newnorm INN or Proposed INN: Newnorm Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN ...	Octapharma Pharmazeutika Prod.Ges.m.b.H	NULL	NA			Female: yes Male: yes	50	Phase 1;Phase 3	United States;Slovakia;Poland;Ukraine;Russian Federation;Germany

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