65. Primary immunodeficiency Clinical trials / Disease details
Clinical trials : 482 / Drugs : 653 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 212
| 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-DE (EUCTR) | 14/12/2021 | 31/05/2021 | Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases | Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases | Primary Immunodeficiency Diseases MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | 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 | ||
| 2 | NCT04640142 (ClinicalTrials.gov) | August 4, 2021 | 17/11/2020 | Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases | Prospective, Open-label, Single-arm, Multicentre Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases | Primary Immune Deficiency | Biological: Newnorm | Octapharma | NULL | Recruiting | 2 Years | 75 Years | All | 50 | Phase 3 | United States;Germany;Poland;Slovakia;Ukraine |
| 3 | EUCTR2020-001496-32-PT (EUCTR) | 11/05/2021 | 11/08/2020 | Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID) | A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study | Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: KIg10 Product Code: KIg10 INN or Proposed INN: Human Immunoglobulin | KEDRION S.P.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Portugal;Hungary;Slovakia;Russian Federation;Italy | ||
| 4 | EUCTR2020-001496-32-SK (EUCTR) | 01/10/2020 | 02/07/2020 | Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID) | A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study | Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: KIg10 Product Code: KIg10 INN or Proposed INN: Human Immunoglobulin | KEDRION S.P.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Portugal;Hungary;Slovakia;Russian Federation;Italy | ||
| 5 | EUCTR2020-001496-32-HU (EUCTR) | 09/09/2020 | 02/07/2020 | Study, in which all know the treatment assigned to the patient, conducted in more sites, to evaluate the efficaty, safety, and metabolism of Kedrion in venous Human Normal Immunoglobulin (IVIg) 10% in child with Primary Immunodeficiency Disease (PID) | A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID) - PID-PED study | Pediatric Patients Affected by Primary Immunodeficiency Disease. MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: KIg10 Product Code: KIg10 INN or Proposed INN: Human Immunoglobulin | KEDRION S.P.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 3 | Portugal;Hungary;Slovakia;Russian Federation;Italy | ||
| 6 | NCT03939533 (ClinicalTrials.gov) | October 17, 2019 | 3/5/2019 | Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases | Clinical Phase 3 Study to Monitor the Safety, Tolerability, and Efficacy of Subcutaneous Human Immunoglobulin (CUTAQUIG®) Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases | Primary Immune Deficiency Disorder | Drug: CUTAQUIG | Octapharma | NULL | Completed | 2 Years | 75 Years | All | 64 | Phase 3 | United States |
| 7 | NCT03988426 (ClinicalTrials.gov) | March 7, 2017 | 13/6/2019 | Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases | Clinical Phase 3 Study to Evaluate the Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Primary Immunodeficiency Diseases. | Primary Immune Deficiency Disorder | Biological: Octanorm | Octapharma | NULL | Completed | 18 Years | 70 Years | All | 25 | Phase 3 | Russian Federation |
| 8 | EUCTR2013-003877-87-SK (EUCTR) | 13/01/2017 | 17/03/2016 | Clinical 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.H | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 1;Phase 3 | United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Russian Federation | ||
| 9 | NCT03907241 (ClinicalTrials.gov) | March 1, 2016 | 7/12/2018 | 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 TRIAL | Title 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 TRIAL | Primary Immunodeficiency | Drug: Octanorm 16.5% | Octapharma | NULL | Completed | 2 Years | 75 Years | All | 27 | Phase 3 | United States;Canada |
| 10 | NCT02627300 (ClinicalTrials.gov) | March 2016 | 3/12/2015 | Study of Octanorm Subcutaneous IG in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 Trial | 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 | Primary Immunodeficiency Disease | Drug: Octanorm 16.5% | Octapharma | NULL | Completed | N/A | N/A | All | 21 | Phase 3 | United States;Canada |
| 11 | EUCTR2013-003877-87-PL (EUCTR) | 11/03/2015 | 04/12/2014 | Clinical 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.H | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | United States;Hungary;Czech Republic;Slovakia;Canada;Poland | ||
| 12 | EUCTR2013-003877-87-HU (EUCTR) | 14/03/2014 | 07/01/2014 | Clinical 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.H | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | United States;Czech Republic;Hungary;Slovakia;Canada;Poland | ||
| 13 | EUCTR2013-003877-87-CZ (EUCTR) | 12/03/2014 | 19/12/2013 | Clinical 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.H | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 1;Phase 3 | United States;Hungary;Czech Republic;Slovakia;Canada;Poland | ||
| 14 | NCT01888484 (ClinicalTrials.gov) | March 2014 | 21/6/2013 | Study of Octanorm Subcutaneous IG in Patients With PID | 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 Immune Deficiency Disorder | Biological: octanorm 16.5% | Octapharma | NULL | Completed | 2 Years | 75 Years | All | 75 | Phase 3 | United States;Canada;Czechia;Hungary;Poland;Russian Federation;Slovakia;Czech Republic |
| 15 | NCT01985373 (ClinicalTrials.gov) | December 2013 | 31/10/2013 | Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml | Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml | Primary Immunodeficiency | Drug: Intravenous immunoglobulin infusion | Sanquin | NULL | Completed | 18 Years | N/A | Both | 23 | Phase 3 | Netherlands |
| 16 | EUCTR2012-005727-32-NL (EUCTR) | 25/07/2013 | 23/05/2013 | The pharmacokinetics (the behaviour in the body) and safety of the intravenous immunoglobulin product Nanogam 100 mg/ml | Pharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml - PK and safety of Nanogam 100 mg/ml | Primary a- or hypogammaglobulinemia MedDRA version: 14.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 100000004870 MedDRA version: 14.1;Classification code 10010509;Term: Congenital hypogammaglobulinemia;System Organ Class: 100000004850 MedDRA version: 14.1;Classification code 10071133;Term: Congenital agammaglobulinemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nanogam 100 mg/ml INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: IVIG Trade Name: Nanogam® 50 mg/ml INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV) Other descriptive name: IVIG | Sanquin Blood Supply Foundation | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 17 | EUCTR2010-023483-41-HU (EUCTR) | 01/03/2011 | 10/11/2010 | A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune system | A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) - I10E-0718 | a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Common variable immunodeficiency (CVID) MedDRA version: 14.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 100000004870 MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;Classification code 10001471;Term: Agammaglobulinemia;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 60 | Serbia;France;Czech Republic;Hungary;Poland;Ukraine;Lithuania | |||
| 18 | NCT01012323 (ClinicalTrials.gov) | January 2010 | 11/11/2009 | A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases | Clinical Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Patients With Primary Immunodeficiency Diseases | Primary Immunodeficiency Diseases | Biological: NewGam | Octapharma | Premier Research Group plc | Completed | 2 Years | 75 Years | All | 51 | Phase 3 | United States |
| 19 | EUCTR2008-000830-30-SE (EUCTR) | 17/12/2008 | 03/11/2008 | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency(IgPro20 EU Extension Study) | PID (primary immunodeficiency) MedDRA version: 9.1;Level: LLT;Classification code 10064859;Term: Primary immunodeficiency syndrome | Product Name: IgPro20 Product Code: IgPro20 INN or Proposed INN: normal human immunoglobulin G | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Germany;France;Spain;Sweden | |||
| 20 | EUCTR2010-023483-41-Outside-EU/EEA (EUCTR) | 11/04/2014 | A multinational study with I10E (Human Immunoglobulin) to demonstrate the efficacy and the safety of the product in patients suffering from deficiency in their immune system | A MULTICENTER STUDY ON THE EFFICACY, SAFETY AND PHARMACOKINETICS OF I10E IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PID) | a primary immunodeficiency as defined by the ESID and validated by a reference centre :• X-linked agammaglobulinemia (XLA)• Common variable immunodeficiency (CVID) MedDRA version: 16.1;Level: LLT;Classification code 10010112;Term: Common variable immunodeficiency;System Organ Class: 100000004870 MedDRA version: 16.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;Classification code 10001471;Term: Agammaglobulinemia;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | NA | Female: yes Male: yes | 60 | Poland;Serbia;Czech Republic;France;Hungary;Lithuania;Ukraine | ||||
| 21 | EUCTR2020-004734-37-PL (EUCTR) | 16/06/2021 | Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases | Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases | Primary Immunodeficiency Diseases MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | 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 | |||
| 22 | EUCTR2020-004734-37-SK (EUCTR) | 02/06/2021 | Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases | Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases | Primary Immunodeficiency Diseases MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | 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 |