Recombinant Human Hyaluronidase (rHuPH20) ( DrugBank: Recombinant human hyaluronidase, Hyaluronidase )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 65 | Primary immunodeficiency | 6 |
65. Primary immunodeficiency
Clinical trials : 500 / Drugs : 614 - (DrugBank : 119) / Drug target genes : 92 - Drug target pathways : 217
Showing 1 to 6 of 6 diseases
| 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 | JPRN-jRCT2041220059 | 24/08/2022 | 26/08/2022 | A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PI ... | A Phase 3, Open-label, Non-controlled, Extension Study to Evaluate the Long-term Safety of TAK-771 in Japanese Patients with Primary Immunodeficiency Disease (PID) A Phase 3, Open-label, Non-controlled, Extension Study to Evaluate the Long-term Safety of TAK-771 i ... | Primary Immunodeficiency Diseases (PID) | TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). P ... | Nishizawa Atsushi | NULL | Pending | >= 2age old | Not applicable | Both | 10 | Phase 3 | Japan |
| 2 | JPRN-jRCT2031210457 | 24/01/2022 | 27/11/2021 | A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID) | A Phase 3, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of TAK-771 in Japanese Subjects with Primary Immunodeficiency Diseases (PID) A Phase 3, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics, Safety and Tolerabilit ... | Primary Immunodeficiency Diseases (PID) | Epoch 1: TAK-771 Ramp up Period TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution. The dose of 10% IGI will be increased from 1/3 of full dose to full dose in 3 weeks for participants who will receive TAK-771 once every 3 week, or from 1/4 of full dose to full dose in 6 weeks for participants who will receive TAK-771 once every 4 week. Epoch 2: TAK-771 Treatment Period TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution, every 3, or 4 weeks for up to Week 24. Epoch 1: TAK-771 Ramp up Period TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant H ... | Nishizawa Atsushi | NULL | Recruiting | >= 2age old | Not applicable | Both | 15 | Phase 3 | Japan |
| 3 | EUCTR2012-000481-38-GB (EUCTR) | 28/06/2012 | 26/04/2012 | Assessment of the safety of Immunoglobulin and recombinant human hylaluronidase in the treatment of patients with primary immunodeficiency Assessment of the safety of Immunoglobulin and recombinant human hylaluronidase in the treatment of ... | Tolerability, Safety and Product Administration Evaluation of rHuPH20 Facilitated Subcutaneous Treatment with Immune Globulin (Human), 10% in Subjects with Primary Immunodeficiency Diseases – A Study in Europe - Tolerability and Safety of IG, 10% with rHuPH20 in PIDD Tolerability, Safety and Product Administration Evaluation of rHuPH20 Facilitated Subcutaneous Treat ... | Primary Immunodeficiency Diseases MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: Primary immunodeficiency syndromes;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Immunodeficiency Diseases MedDRA version: 14.1;Level: HLT;Classification code 10036700;Term: ... | Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Recombinant Human Hyaluronidase (rHuPH20) INN or Proposed INN: HYALURONIDASE Other descriptive name: 36-482-Hyaluronoglucosaminidase PH20 (rHuPH20) Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Product Name: Recombinant Human Hyaluronidase (rHuPH20) INN or Proposed INN: HYALURONIDASE Other descriptive name: 36-482-Hyaluronoglucosaminidase PH20 (rHuPH20) Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: Human normal immunoglobulin INN or Pr ... | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Czech Republic;Belgium;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden | |||
| 4 | NCT01485796 (ClinicalTrials.gov) | December 29, 2011 | 2/12/2011 | Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD | Tolerability, Safety and Administration Mode Evaluation of Recombinant Human Hyaluronidase (rHuPH20) Facilitated Subcutaneous Treatment With Immune Globulin Infusion (Human), 10% in Subjects With Primary Immunodeficiency Diseases (PIDD) Tolerability, Safety and Administration Mode Evaluation of Recombinant Human Hyaluronidase (rHuPH20) ... | Primary Immunodeficiency Diseases (PID) | Biological: Immune Globulin Infusion (Human), 10%;Biological: Recombinant human hyaluronidase | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 54 | Phase 2/Phase 3 | United States |
| 5 | NCT01175213 (ClinicalTrials.gov) | July 28, 2010 | 3/8/2010 | Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID | Long-Term Tolerability and Safety of Immune Globulin Subcutaneous (IGSC) Solution Administered Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases Long-Term Tolerability and Safety of Immune Globulin Subcutaneous (IGSC) Solution Administered Subcu ... | Primary Immunodeficiency Diseases (PID) | Biological: SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety);Biological: SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety);Biological: IV treatment with IGSC, 10% Biological: SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety);Biologic ... | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 66 | Phase 3 | United States |
| 6 | NCT00814320 (ClinicalTrials.gov) | December 18, 2008 | 23/12/2008 | Gammagard Liquid and rHuPH20 in PID | Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (G ... | Primary Immunodeficiency Diseases (PID) | Biological: Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV) | Baxalta now part of Shire | NULL | Completed | 2 Years | N/A | All | 89 | Phase 3 | United States;Canada |