Recombinant human hyaluronidase ( DrugBank: Recombinant human hyaluronidase, Hyaluronidase )

3 diseases

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	1
28	全身性アミロイドーシス	17
65	原発性免疫不全症候群	7

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

臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24

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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-jRCT2051210110	07/12/2021	14/10/2021	A Study of TAK-771 in Japanese Participants with Chronic Inflammatory Demyelinating Polyradiculoneur ...	A Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of TAK-771 for the Treatment of Ch ...	Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal Motor Neuropathy (MM ...	Cohort 1: TAK-771 for CIDP Participants TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recom ...	Nishizawa Atsushi	NULL	Recruiting	>= 18age old	Not applicable	Both	21	Phase 3	Japan

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28. 全身性アミロイドーシス

臨床試験数 : 267 / 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2021-002639-48-DE (EUCTR)	25/07/2022	15/12/2021	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	Amyloid Light Chain Amyloidosis MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: A ...	Trade Name: DAZARLEX Product Name: Daratumumab co-formulated with recombinant human hyaluronidase(rHu ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	150	Phase 2	France;United States;Greece;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
2	EUCTR2021-002639-48-NL (EUCTR)	10/06/2022	09/02/2022	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	Amyloid Light Chain Amyloidosis MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: A ...	Trade Name: DAZARLEX Product Name: Daratumumab co-formulated with recombinant human hyaluronidase(rHu ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	150	Phase 2	United States;France;Greece;Canada;Spain;Germany;Netherlands;United Kingdom;Italy
3	EUCTR2021-002639-48-ES (EUCTR)	08/03/2022	28/12/2021	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain ...	Amyloid Light Chain Amyloidosis MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: A ...	Trade Name: DAZARLEX Product Name: Daratumumab co-formulated with recombinant human hyaluronidase(rHu ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	150	Phase 2	France;United States;Greece;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
4	EUCTR2018-004333-33-FR (EUCTR)	23/01/2020	02/12/2019	Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain ...	Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain ...	Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification ...	Trade Name: Velcade Product Name: Bortezomib Product Code: 26866138 INN or Proposed INN: BORTEZOMIB Prod ...	European Myeloma Network	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	40	Phase 2	France;Greece;Netherlands;Italy
5	EUCTR2018-004333-33-IT (EUCTR)	01/08/2019	28/04/2020	Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain ...	Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain ...	Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification ...	Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 INN or Proposed INN: DARATUMU ...	European Myeloma Network	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	40	Phase 2	France;Greece;Netherlands;Italy
6	EUCTR2018-004333-33-NL (EUCTR)	24/07/2019	08/07/2019	Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain ...	Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain ...	Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification ...	Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 INN or Proposed INN: DARATUMU ...	European Myeloma Network	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	40	Phase 2	France;Greece;Netherlands;Italy
7	EUCTR2018-004333-33-GR (EUCTR)	08/07/2019	05/06/2019	Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain ...	Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain ...	Patients with newly diagnosed stage 3B AL amyloidosis MedDRA version: 20.0;Level: PT;Classification ...	Trade Name: Darzalex Product Name: Daratumumab Product Code: JNJ-54767414 INN or Proposed INN: DARATUMU ...	European Myeloma Network	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	40	Phase 2	France;Greece;Netherlands;Italy
8	EUCTR2016-001737-27-GB (EUCTR)	08/10/2018	11/01/2018	A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bor ...	A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cy ...	AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classificat ...	Product Name: Daratumumab co-formulated with recombinant human hyaluronidase(rHuPH20) Product Code: J ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	370	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Be ...
9	EUCTR2016-001737-27-PL (EUCTR)	06/09/2018	16/07/2018	A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bor ...	A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cy ...	AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classificat ...	Product Name: Daratumumab co-formulated with recombinant human hyaluronidase(rHuPH20) Product Code: J ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	370	Phase 3	United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Belgium;P ...
10	EUCTR2016-001737-27-DK (EUCTR)	22/08/2018	04/06/2018	A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bor ...	A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cy ...	AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis ) MedDRA version: 20.0;Level: PT;Classificat ...	Product Name: Daratumumab co-formulated with recombinant human hyaluronidase(rHuPH20) Product Code: J ...	Janssen-Cilag International N.V.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	370	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Be ...

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65. 原発性免疫不全症候群

臨床試験数 : 500 / 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217

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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 (PI ...	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). Pa ...	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 Tolerabilit ...	Primary Immunodeficiency Diseases (PID)	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 ...	Tolerability, Safety and Product Administration Evaluation of rHuPH20 Facilitated Subcutaneous Treat ...	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 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) ...	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 Subcu ...	Primary Immunodeficiency Diseases (PID)	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% (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
7	NCT00782106 (ClinicalTrials.gov)	December 4, 2006	29/10/2008	Study to Determine the Dose of Recombinant Human HyaluronidaseNeeded to Infuse a Full Dose of IGIV S ...	Phase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up ...	Primary Immunodeficiency Diseases (PID)	Biological: Recombinant human hyaluronidase + immune globulin intravenous	Baxalta now part of Shire	NULL	Completed	16 Years	N/A	All	11	Phase 1/Phase 2	United States

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