65. Primary immunodeficiency Clinical trials / Disease details


Clinical trials : 482 Drugs : 653 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 212

  
8 trials found
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PhaseCountries
1NCT03988426
(ClinicalTrials.gov)
March 7, 201713/6/2019Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency DiseasesClinical Phase 3 Study to Evaluate the Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Primary Immunodeficiency Diseases.Primary Immune Deficiency DisorderBiological: OctanormOctapharmaNULLCompleted18 Years70 YearsAll25Phase 3Russian Federation
2EUCTR2013-003877-87-SK
(EUCTR)
13/01/201717/03/2016Clinical trial to confirm and expand information on absorption, distribution, elimination in the body, efficacy, tolerability and safety of a new drug in patients with impaired immune system.CLINICAL PHASE III STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, TOLERABILITY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN(OCTANORM 16.5%) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES Primary immunodeficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Octanorm 16.5%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Octapharma Pharmazeutika Prod.Ges.m.b.HNULLNot RecruitingFemale: yes
Male: yes
64Phase 1;Phase 3United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Russian Federation
3NCT03907241
(ClinicalTrials.gov)
March 1, 20167/12/2018CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIALTitle for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES WHO HAVE COMPLETED THE SCGAM-01 TRIAL Title for SCGAM-03 in Canada: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIALPrimary ImmunodeficiencyDrug: Octanorm 16.5%OctapharmaNULLCompleted2 Years75 YearsAll27Phase 3United States;Canada
4NCT02627300
(ClinicalTrials.gov)
March 20163/12/2015Study of Octanorm Subcutaneous IG in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 TrialClinical Phase III Study to Monitor the Safety, Tolerability and Efficacy of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 TrialPrimary Immunodeficiency DiseaseDrug: Octanorm 16.5%OctapharmaNULLCompletedN/AN/AAll21Phase 3United States;Canada
5EUCTR2013-003877-87-PL
(EUCTR)
11/03/201504/12/2014Clinical trial to confirm and expand information on absorption, distribution, elimination in the body, efficacy, tolerability and safety of a new drug in patients with impaired immune system.CLINICAL PHASE III STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, TOLERABILITY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN(OCTANORM 16.5%) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES Primary immunodeficiency
MedDRA version: 20.0;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Octanorm 16.5%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Octapharma Pharmazeutika Prod.Ges.m.b.HNULLNot RecruitingFemale: yes
Male: yes
64Phase 3United States;Hungary;Czech Republic;Slovakia;Canada;Poland
6EUCTR2013-003877-87-HU
(EUCTR)
14/03/201407/01/2014Clinical trial to confirm and expand information on absorption, distribution, elimination in the body, efficacy, tolerability and safety of a new drug in patients with impaired immune system.CLINICAL PHASE III STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, TOLERABILITY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN(OCTANORM 16.5%) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES Primary immunodeficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Octanorm 16.5%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Octapharma Pharmazeutika Prod.Ges.m.b.HNULLNot RecruitingFemale: yes
Male: yes
64Phase 3United States;Czech Republic;Hungary;Slovakia;Canada;Poland
7EUCTR2013-003877-87-CZ
(EUCTR)
12/03/201419/12/2013Clinical trial to confirm and expand information on absorption, distribution, elimination in the body, efficacy, tolerability and safety of a new drug in patients with impaired immune system.CLINICAL PHASE III STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, TOLERABILITY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN(OCTANORM 16.5%) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES Primary immunodeficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Octanorm 16.5%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Octapharma Pharmazeutika Prod.Ges.m.b.HNULLNot RecruitingFemale: yes
Male: yes
64Phase 1;Phase 3United States;Hungary;Czech Republic;Slovakia;Canada;Poland
8NCT01888484
(ClinicalTrials.gov)
March 201421/6/2013Study of Octanorm Subcutaneous IG in Patients With PIDClinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency DiseasesPrimary Immune Deficiency DisorderBiological: octanorm 16.5%OctapharmaNULLCompleted2 Years75 YearsAll75Phase 3United States;Canada;Czechia;Hungary;Poland;Russian Federation;Slovakia;Czech Republic