RG6042, formerly ISIS 443139, IONIS-HTTRx ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 8 | ハンチントン病 | 12 |
8. ハンチントン病
臨床試験数 : 242 / 薬物数 : 205 - (DrugBank : 62) / 標的遺伝子数 : 85 - 標的パスウェイ数 : 159
| 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 | EUCTR2018-003898-94-AT (EUCTR) | 10/12/2020 | 14/10/2020 | An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease | AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: tominersen Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 2 | EUCTR2018-003898-94-NL (EUCTR) | 01/10/2020 | 08/10/2020 | An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease | AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: tominersen Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Phase 3 | United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;New Zealand | ||
| 3 | EUCTR2018-002987-14-NL (EUCTR) | 23/07/2019 | 25/02/2019 | A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease | A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: not available Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Netherlands;United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;New Zealand | ||
| 4 | EUCTR2018-003898-94-ES (EUCTR) | 21/06/2019 | 11/06/2019 | An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease | AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: not available Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTD | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Spain;Austria;Russian Federation;Chile;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 5 | EUCTR2018-002987-14-DK (EUCTR) | 11/04/2019 | 15/02/2019 | A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease | A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: not available Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Denmark;Australia;Netherlands;Germany;China;Japan;New Zealand | ||
| 6 | EUCTR2018-002987-14-AT (EUCTR) | 27/03/2019 | 22/03/2019 | A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease | A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: not available Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 7 | EUCTR2018-002987-14-PL (EUCTR) | 19/03/2019 | 07/04/2020 | A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease | A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: not available Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 801 | Phase 3 | United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;New Zealand | ||
| 8 | EUCTR2018-003898-94-GB (EUCTR) | 07/03/2019 | 13/12/2018 | An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients with Huntington’s Disease | AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH HUNTINGTON’S DISEASE | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: tominersen Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Spain;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 9 | EUCTR2018-002987-14-IT (EUCTR) | 27/02/2019 | 15/06/2021 | A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease | A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE. - A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Pati | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: - Product Code: [Ro 723-4292/F02] INN or Proposed INN: - Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 801 | Phase 3 | United States;Spain;Austria;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;Japan;New Zealand | ||
| 10 | EUCTR2018-002987-14-GB (EUCTR) | 13/02/2019 | 08/02/2019 | A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients with Manifest Huntington's disease | A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE | Huntington's disease (HD) MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: not available Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Argentina;Poland;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 11 | EUCTR2017-002471-25-GB (EUCTR) | 18/10/2018 | 04/08/2017 | An extension study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the study drug, RO7234292 (ISIS 443139), in patients who participated in prior investigational studies of RO7234292 | AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7234292 (ISIS 443139) IN HUNTINGTON'S DISEASE PATIENTS WHO PARTICIPATED IN PRIOR INVESTIGATIONAL STUDIES OF RO7234292 (ISIS 443139) | Early Manifest Huntington's Disease MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: n.a. Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 1;Phase 2 | Canada;United Kingdom;Germany | ||
| 12 | EUCTR2017-002471-25-DE (EUCTR) | 10/01/2018 | 07/08/2017 | An extension study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the study drug, RO7234292 (ISIS 443139), in patients who participated in prior investigational studies of RO7234292 | An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington’s Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139) | Early Manifest Huntington's Disease MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: Ro 723-4292/F02 INN or Proposed INN: n.a. Other descriptive name: RG6042, formerly ISIS 443139, IONIS-HTTRx | F.Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | Canada;Germany;United Kingdom |