Immunoglobulins (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 5 |
| 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 | EUCTR2020-002438-34-DK (EUCTR) | 19/08/2020 | 11/06/2020 | Fampridine for treatment of functional disability in patients with immune mediated polyneuropathy | Fampridine for treatment of residual neurological deficits in patients treated with immunoglobulins for chronic inflammatory demyelinating polyneuropathy | Chronic inflammatory demyelinating polyneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10072650;Term: CIDP;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Fampyra Product Name: Fampyra INN or Proposed INN: FAMPRIDINE | Department of Neurology, Odense University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Denmark | ||
| 2 | EUCTR2015-000828-28-NL (EUCTR) | 26/07/2016 | 30/11/2015 | Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed. | Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - Hymne | Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hyqvia Product Name: Hyqvia | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 3 | NCT02111590 (ClinicalTrials.gov) | January 2014 | 9/4/2014 | Immunoglobulin Dosage and Administration Form in CIDP and MMN | The Influence of Immunoglobulin Dosage and Administration on Development of Hemolytic Anemia and Variation on Muscle Strength in Patients With CIDP and MMN | Chronic Inflammatory Demyelinating Polyneuropathy;Multifocal Motor Neuropathy;Hemolytic Anemia | Drug: Immunoglobulins | Rigshospitalet, Denmark | Aarhus University Hospital;Octapharma Pharmazeutika Produktionsges.m.b.H. | Completed | 18 Years | 80 Years | Both | 36 | N/A | Denmark |
| 4 | EUCTR2007-000710-37-IT (EUCTR) | 04/10/2007 | 12/02/2008 | A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND | A multicentre study of subcutaneous immunoglobulin in patients with Multifocal Motor Neuropathy (MMN) - ND | Maintenance treatment with subcutaneous immunoglobulin (Vivaglobin) in patients with MMN. MedDRA version: 9.1;Level: LLT;Classification code 10036105;Term: Polyneuropathy | Trade Name: Vivaglobin INN or Proposed INN: Immunoglobulins, normal human, for extravascular adm. | CSL Behring AG | NULL | Not Recruiting | Female: yes Male: yes | 10 | United Kingdom;Germany;Italy | |||
| 5 | EUCTR2005-001136-76-IT (EUCTR) | 09/07/2007 | 07/09/2007 | Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDP | Double blind Randomized Controlled trial of prolonged treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)with high dose intravenous immunoglobulins (IVIg) or intravenous metilprednisolone (IVMP). A phase III study. - IVIg CIDP | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: IGVENA*FL 200ML 10G+SET INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm. | KEDRION | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy |