65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
臨床試験数 : 482 / 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 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 | EUCTR2021-000136-59-BG (EUCTR) | 12/11/2021 | 05/10/2021 | A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II | Hereditary Angioedema Type I or II MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 100000004850 MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: KVD824 300 mg Modified Release Tablets INN or Proposed INN: To be confirmed Other descriptive name: KVD824 hydrochloride | Kalvista Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | United States;Czechia;North Macedonia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Romania;Australia;Bulgaria;Germany;New Zealand | ||
| 2 | EUCTR2021-000136-59-CZ (EUCTR) | 13/10/2021 | 25/08/2021 | A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II | Hereditary Angioedema Type I or II MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 100000004850 MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: KVD824 300 mg Modified Release Tablets INN or Proposed INN: To be confirmed Other descriptive name: KVD824 hydrochloride | Kalvista Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | United States;Czechia;North Macedonia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Romania;Australia;Bulgaria;Germany;New Zealand | ||
| 3 | EUCTR2021-000136-59-HU (EUCTR) | 24/09/2021 | 16/07/2021 | A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II | Hereditary Angioedema Type I or II MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 100000004850 MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: KVD824 300 mg Modified Release Tablets INN or Proposed INN: To be confirmed Other descriptive name: KVD824 hydrochloride | Kalvista Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | United States;Czechia;North Macedonia;Italy;United Kingdom;France;Hungary;Canada;Romania;Australia;Bulgaria;Germany;New Zealand | ||
| 4 | EUCTR2021-000136-59-DE (EUCTR) | 20/09/2021 | 22/07/2021 | A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II. | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II | Hereditary Angioedema Type I or II MedDRA version: 21.0;Level: LLT;Classification code 10080956;Term: Hereditary angioedema type I;System Organ Class: 100000004850 MedDRA version: 24.0;Classification code 10080960;Term: Hereditary angioedema type II;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: KVD824 300 mg Modified Release Tablets INN or Proposed INN: To be confirmed Other descriptive name: KVD824 hydrochloride | Kalvista Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | United States;Czechia;North Macedonia;Italy;United Kingdom;France;Hungary;Canada;Romania;Australia;Bulgaria;Germany;New Zealand | ||
| 5 | NCT00527878 (ClinicalTrials.gov) | September 2007 | 8/9/2007 | Effect of Ranitidine on Hyper-IgE Recurrent Infection (Job's) Syndrome | A Double-Blind, Randomized, Placebo-Controlled Cross-Over Study Assessing the Role of Pathogen-Specific IgE and Histamine Release in the Hyper-IgE Syndrome and the Effect of Ranitidine on Laboratory and Clinical Manifestations | JOB's Syndrome;Hyper-IgE Recurrent Infection Syndrome;Immune Deficiency | Drug: Ranitidine;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Terminated | 2 Years | N/A | All | 16 | Phase 2 | United States |