( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 302 | レーベル遺伝性視神経症 | 23 |
302. レーベル遺伝性視神経症
臨床試験数 : 23 / 薬物数 : 15 - (DrugBank : 5) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 33
Showing 1 to 10 of 23 trials
| 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 | NCT05293626 (ClinicalTrials.gov) | January 202320230100 | 9/12/202120211209 | Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ND4 Mutations Gene Therapy Clinical Trial for the Treatment of Leber's Hereditary Optic Neuropathy Associated With ... | A Phase 1/2, Single-Arm, Open-Label, Dose-Finding Clinical Trial to Evaluate the Safety and Efficacy of Gene Therapy for Leber's Hereditary Optic Neuropathy (LHON) Associated With ND4 Mutation A Phase 1/2, Single-Arm, Open-Label, Dose-Finding Clinical Trial to Evaluate the Safety and Efficacy ... | Leber Hereditary Optic Neuropathy (LHON) | Drug: NR082 Injection;Device: Injection needle | Neurophth Therapeutics Inc | NULL | Not yet recruiting | 18 Years | 75 Years | All | 18 | Phase 1/Phase 2 | NULL |
| 2 | EUCTR2017-002187-40-NL (EUCTR) | 19/06/201920190619 | 26/09/201820180926 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year - REFLECT Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Place ... | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene;Therapeutic area: Diseases [C] - Eye Diseases [C11] Leber Hereditary Optic Neuropathydue to mutations in the mitochondrial NADH Dehydrogenase 4 gene;The ... | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: lenadogene nolparvovec Other descriptive name: Recombinant Adeno-Associated Viral vector, serotype 2 (rAAV2/2) containing the human wild-type mitochondrial NADH Dehydrogenase 4 gene (ND4) Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gen ... | GENSIGHT BIOLOGICS | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | France;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 3 | NCT04561466 (ClinicalTrials.gov) | March 26, 201920190326 | 14/3/201920190314 | Trial of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy | Study of Efficacy of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy | Safety Issues;Efficacy, Self | Drug: Béfizal | Hôpital Necker-Enfants Malades | European Georges Pompidou Hospital;CLAIROP | Recruiting | 18 Years | N/A | All | 14 | Phase 2/Phase 3 | France |
| 4 | NCT03672968 (ClinicalTrials.gov) | February 22, 201920190222 | 13/9/201820180913 | EAP_GS010_single Patient | EAP Single Patient: Safety of Bilateral Intravitreal Injection of GS010 in a Single Subject Affected With G11778A ND4 Leber Hereditary Optic Neuropathy EAP Single Patient: Safety of Bilateral Intravitreal Injection of GS010 in a Single Subject Affected ... | Leber Hereditary Optic Neuropathy (Optic, Atrophy, Hereditary, Leber) | Genetic: GS010 | GenSight Biologics | NULL | Available | N/A | N/A | All | NULL | ||
| 5 | EUCTR2017-002187-40-IT (EUCTR) | 04/12/201820181204 | 29/01/202120210129 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year - REFLECT Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Place ... | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene MedDRA version: 20.1;Level: LLT;Classification code 10062951;Term: Leber's hereditary optic atrophy neuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Eye Diseases [C11] Leber Hereditary Optic Neuropathydue to mutations in the mitochondrial NADH Dehydrogenase 4 gene Med ... | Product Name: Recombinant AAV vector serotype 2 containing the human wild typemitochondrial ND4 gene Product Code: [GS010] INN or Proposed INN: lenadogene nolparvovec Product Name: Recombinant AAV vector serotype 2 containing the human wild typemitochondrial ND4 gene ... | GENSIGHT BIOLOGICS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | France;Spain;Belgium;Netherlands;United Kingdom;Italy | ||
| 6 | EUCTR2017-002153-11-IT (EUCTR) | 12/07/201820180712 | 12/03/201820180312 | Long-term Follow-up of ND4 LHON Subjects Treated With GS010 Ocular Gene Therapy in the RESCUE or REVERSE Phase III Clinical Trials Long-term Follow-up of ND4 LHON Subjects Treated With GS010 Ocular Gene Therapy in the RESCUE or REV ... | Long-term Follow-up of ND4 LHON Subjects Treated With GS010 Ocular Gene Therapy in the RESCUE or REVERSE Phase III Clinical Trials - RESCUE and REVERSE Long-term Follow-up Long-term Follow-up of ND4 LHON Subjects Treated With GS010 Ocular Gene Therapy in the RESCUE or REV ... | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene MedDRA version: 20.1;Level: LLT;Classification code 10062951;Term: Leber's hereditary optic atrophy neuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Eye Diseases [C11] Leber Hereditary Optic Neuropathydue to mutations in the mitochondrial NADH Dehydrogenase 4 gene Med ... | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gen ... | GENSIGHT BIOLOGICS | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 4 | United States;France;Germany;United Kingdom;Italy | ||
| 7 | EUCTR2017-002187-40-FR (EUCTR) | 15/06/201820180615 | 16/01/201820180116 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year - REFLECT Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Place ... | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrialNADH Dehydrogenase 4 gene MedDRA version: 20.1;Level: LLT;Classification code 10062951;Term: Leber's hereditary optic atrophy neuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Eye Diseases [C11] Leber Hereditary Optic Neuropathydue to mutations in the mitochondrialNADH Dehydrogenase 4 gene MedD ... | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: lenadogene nolparvovec Other descriptive name: Recombinant Adeno-Associated Viral vector, serotype 2 (rAAV2/2) containing the human wild-type mitochondrial NADH Dehydrogenase 4 gene (ND4) Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gen ... | GENSIGHT BIOLOGICS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | France;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 8 | EUCTR2017-002187-40-ES (EUCTR) | 23/05/201820180523 | 02/03/201820180302 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010 | A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year - REFLECT A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber He ... | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene MedDRA version: 20.1;Level: LLT;Classification code 10062951;Term: Leber's hereditary optic atrophy neuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Eye Diseases [C11] Leber Hereditary Optic Neuropathydue to mutations in the mitochondrial NADH Dehydrogenase 4 gene Med ... | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: lenadogene nolparvovec Other descriptive name: Recombinant Adeno-Associated Viral vector, serotype 2 (rAAV2/2) containing the human wild-type mitochondrial NADH Dehydrogenase 4 gene (ND4) Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gen ... | GENSIGHT BIOLOGICS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | France;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 9 | EUCTR2017-002187-40-GB (EUCTR) | 30/03/201820180330 | 18/01/201820180118 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year - REFLECT Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Place ... | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene MedDRA version: 20.1;Level: LLT;Classification code 10062951;Term: Leber's hereditary optic atrophy neuropathy;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Eye Diseases [C11] Leber Hereditary Optic Neuropathydue to mutations in the mitochondrial NADH Dehydrogenase 4 gene Med ... | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: lenadogene nolparvovec Other descriptive name: Recombinant Adeno-Associated Viral vector, serotype 2 (rAAV2/2) containing the human wild-type mitochondrial NADH Dehydrogenase 4 gene (ND4) Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gen ... | GENSIGHT BIOLOGICS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | France;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 10 | EUCTR2017-002187-40-BE (EUCTR) | 15/03/201820180315 | 16/01/201820180116 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010 | Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year - REFLECT Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Place ... | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene;Therapeutic area: Diseases [C] - Eye Diseases [C11] Leber Hereditary Optic Neuropathydue to mutations in the mitochondrial NADH Dehydrogenase 4 gene;The ... | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: lenadogene nolparvovec Other descriptive name: Recombinant Adeno-Associated Viral vector, serotype 2 (rAAV2/2) containing the human wild-type mitochondrial NADH Dehydrogenase 4 gene (ND4) Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gen ... | GENSIGHT BIOLOGICS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | France;Spain;Belgium;Netherlands;Italy;United Kingdom |