BMN 111 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 276 | 軟骨無形成症 | 21 |
276. 軟骨無形成症
臨床試験数 : 51 / 薬物数 : 34 - (DrugBank : 6) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 26
Showing 1 to 10 of 21 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 | EUCTR2020-001055-40-GB (EUCTR) | 29/07/2020 | 19/05/2020 | Open-label clinical trial with an open-label extension to investigate the safety of BMN 111 in infants and young children with achondroplasia Open-label clinical trial with an open-label extension to investigate the safety of BMN 111in infant ... | A randomized, controlled, open-label clinical trial with an open-label extension to investigate the safety of BMN 111 in infants and young children with achondroplasia at risk of requiring cervicomedullary decompression surgery A randomized, controlled, open-label clinical trial with an open-label extension to investigate the ... | achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;Sys ... | Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Propo ... | BioMarin Pharmaceutical Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Australia;United Kingdom | ||
| 2 | EUCTR2018-004364-66-GB (EUCTR) | 22/10/2019 | 11/09/2019 | A Phase 2 open-label long-term study of BMN 111 in children with Achondroplasia | A Phase 2 Open-Label Long-Term Extension Study to Evaluate the Safetyand Efficacy of BMN 111 in Children with Achondroplasia A Phase 2 Open-Label Long-Term Extension Study to Evaluate the Safetyand Efficacy of BMN 111in Child ... | Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;Sys ... | Product Name: Modified recombinant human c-type Product Code: Natriuretic peptide INN or Proposed INN: Vosoritide Other descriptive name: MODIFIED RHCNP Product Name: Modified recombinant human c-type Product Code: Natriuretic peptide INN or Proposed INN: Vosoritide Other descriptive name: MODIFIED RHCNP Product Name: Modified recombinant human c-type Product Code: Natriuretic peptide INN or Proposed INN: ... | BioMarin Pharmaceutical Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | United States;Australia;Japan;United Kingdom | ||
| 3 | NCT03989947 (ClinicalTrials.gov) | June 12, 2019 | 22/5/2019 | An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia | A Phase 2 Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111 in Children With Achondroplasia A Phase 2 Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111in Chil ... | Achondroplasia | Drug: Active BMN 111: Subcutaneous injection of recommended dose of BMN 111 based on weight-band dosing once daily. Drug: Active BMN 111: Subcutaneous injection of recommended dose of BMN 111based on weight-band dosi ... | BioMarin Pharmaceutical | NULL | Active, not recruiting | 15 Months | N/A | All | 73 | Phase 2 | United States;Australia;Japan;United Kingdom |
| 4 | EUCTR2017-002404-28-DE (EUCTR) | 07/03/2019 | 13/12/2018 | A Phase 3 Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111 in Children with Achondroplasia A Phase 3 Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111in Children with A ... | A Phase 3, Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111 in Children with Achondroplasia A Phase 3, Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111in Chi ... | Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;Sys ... | Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Propo ... | BioMarin Pharmaceutical Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | United States;Spain;Turkey;Australia;Germany;Japan;United Kingdom | ||
| 5 | EUCTR2017-002404-28-ES (EUCTR) | 08/11/2018 | 23/11/2018 | A Phase 3 Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111 in Children with Achondroplasia A Phase 3 Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111in Children with A ... | A Phase 3, Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111 in Children with Achondroplasia A Phase 3, Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111in Chi ... | Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;Sys ... | Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Propo ... | BioMarin Pharmaceutical Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | United States;Spain;Turkey;Australia;Germany;Japan;United Kingdom | ||
| 6 | EUCTR2017-002404-28-GB (EUCTR) | 12/10/2018 | 15/06/2018 | A Phase 3 Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111 in Children with Achondroplasia A Phase 3 Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111in Children with A ... | A Phase 3, Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111 in Children with Achondroplasia A Phase 3, Open-Label Long-Term Extension Study to Evaluate the Safety and Efficacy of BMN 111in Chi ... | Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;Sys ... | Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Propo ... | BioMarin Pharmaceutical Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 119 | Phase 3 | United States;Spain;Turkey;Australia;Germany;Japan;United Kingdom | ||
| 7 | EUCTR2016-003826-18-GB (EUCTR) | 12/09/2018 | 30/05/2018 | A Phase 2 Study to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children with Achondroplasia A Phase 2 Study to Evaluate the Safety and Efficacy of BMN 111in Infants and Young Children with Ach ... | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children with Achondroplasia, Age 0 to < 60 Months A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Eff ... | Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] Achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;Sys ... | Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Propo ... | BioMarin Pharmaceutical Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ... | United States;Australia;Japan;United Kingdom | ||
| 8 | JPRN-JapicCTI-184167 | 19/7/2018 | 23/10/2018 | A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia | A Phase 3 Randomized, Double-Blind,Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BMN 111 in Children with Achondroplasia A Phase 3 Randomized, Double-Blind,Placebo-Controlled, Multicenter Study to Evaluate the Efficacy an ... | Achondroplasia | Intervention name : modified recombinant human C-type natriuretic peptide INN of the intervention : Vosoritide Dosage And administration of the intervention : Subcutaneous injection of 15 micro g/kg of BMN 111 daily Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Subcutaneous injection of placebo daily Intervention name : modified recombinant human C-type natriuretic peptide INN of the intervention : V ... | BioMarin Pharmaceutical Inc.(ICCC:EPS International Holdings Co. Ltd.) | NULL | complete | 5 | 18 | BOTH | 6 | Phase 3 | Japan, North America, Europe, Oceania |
| 9 | NCT03583697 (ClinicalTrials.gov) | May 23, 2018 | 14/6/2018 | A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111in Infants and Young Children With Ac ... | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia, Age 0 to < 60 Months A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Eff ... | Achondroplasia | Drug: BMN 111;Drug: Placebo | BioMarin Pharmaceutical | NULL | Completed | N/A | 59 Months | All | 75 | Phase 2 | United States;Australia;Japan;United Kingdom |
| 10 | EUCTR2015-003836-11-DE (EUCTR) | 14/02/2018 | 21/08/2017 | A Phase 3 Study to Evaluate the Safety and Efficacy of BMN 111 in Children with Achondroplasia | A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BMN 111 in Children with Achondroplasia. A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy a ... | achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] achondroplasia MedDRA version: 20.0;Level: LLT;Classification code 10000452;Term: Achondroplasia;Sys ... | Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: Vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: Vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Proposed INN: Vosoritide Other descriptive name: MODIFIED RHCNP Product Name: modified recombinant human C-type natriuretic peptide Product Code: BMN 111 INN or Propo ... | BioMarin Pharmaceutical Inc. | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | United States;Spain;Turkey;Australia;Germany;United Kingdom;Japan |