265. 脂肪萎縮症 Lipodystrophy Clinical trials / Disease details
臨床試験数 : 116 / 薬物数 : 170 - (DrugBank : 61) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 97
| 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 | EUCTR2007-003233-16-ES (EUCTR) | 11/12/2007 | 22/10/2007 | A multicenter, double-blind, randomized, placebo-controlled extension study assessing the efficacy and long-term safety of a 2mg dose of TH9507, a growth hormone releasing factor analog, in HIV subjects with excess abdominal fat accumulation.Estudio de extesión, multicéntrico, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y seguridad a largo plazo de una dosis de 2 mg de TH9507, un análogo del factor liberador de la hormona de crecimiento, en sujetos con VIH con acumulación excesiva de grasa abdominal. | A multicenter, double-blind, randomized, placebo-controlled extension study assessing the efficacy and long-term safety of a 2mg dose of TH9507, a growth hormone releasing factor analog, in HIV subjects with excess abdominal fat accumulation.Estudio de extesión, multicéntrico, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y seguridad a largo plazo de una dosis de 2 mg de TH9507, un análogo del factor liberador de la hormona de crecimiento, en sujetos con VIH con acumulación excesiva de grasa abdominal. | Lipodistrofia asociada a VIH.HIV-associated lipodystrophy. MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: Tesamorelin Product Code: TH9507 INN or Proposed INN: Tesamorelin Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | United Kingdom;Belgium;France;Spain | |||
| 2 | EUCTR2007-003233-16-GB (EUCTR) | 29/11/2007 | 02/08/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | HIV-associated lipodystrophy MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: Tesamorelin Product Code: TH9507 INN or Proposed INN: Tesamorelin Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Belgium;United Kingdom | ||
| 3 | EUCTR2007-003233-16-FR (EUCTR) | 19/09/2007 | 31/07/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | HIV-associated lipodystrophy MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: Tesamorelin Product Code: TH9507 INN or Proposed INN: Tesamorelin Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United Kingdom;Belgium;France;Spain | |||
| 4 | EUCTR2007-003233-16-BE (EUCTR) | 05/09/2007 | 22/08/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | A Multicenter, Double-blind, Randomized, Placebo-Controlled Extension Study Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation. | HIV-associated lipodystrophy MedDRA version: 9.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: Tesamorelin Product Code: TH9507 INN or Proposed INN: Tesamorelin Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | United Kingdom;Belgium;France;Spain | |||
| 5 | NCT00608023 (ClinicalTrials.gov) | August 2007 | 23/1/2008 | TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy | A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Subjects With Excess Abdominal Fat Accumulation | Lipodystrophy;HIV Infections | Drug: Tesamorelin;Drug: Placebo for Tesamorelin | Theratechnologies | NULL | Completed | 18 Years | 65 Years | All | 263 | Phase 3 | United States;Belgium;Canada;France;Spain;United Kingdom |
| 6 | EUCTR2006-005444-88-DE (EUCTR) | 21/06/2007 | 14/08/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | HIV-associated lipodystrophy MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | United Kingdom;Germany;France;Spain | |||
| 7 | EUCTR2006-005444-88-GB (EUCTR) | 08/05/2007 | 26/01/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | HIV-associated lipodystrophy MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Belgium;Germany;United Kingdom | ||
| 8 | EUCTR2006-005444-88-ES (EUCTR) | 25/04/2007 | 03/03/2010 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.Estudio aleatorizado, doble ciego, multicéntrico y controlado por placebo, en el que se evalúa la eficacia y la seguridad de una dosis de 2 mg de TH9507, una sustancia análoga al factor liberador de la hormona del crecimiento, para pacientes de VIH con acumulación excesiva de tejido adiposo abdominal. | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation.Estudio aleatorizado, doble ciego, multicéntrico y controlado por placebo, en el que se evalúa la eficacia y la seguridad de una dosis de 2 mg de TH9507, una sustancia análoga al factor liberador de la hormona del crecimiento, para pacientes de VIH con acumulación excesiva de tejido adiposo abdominal. | HIV-associated lipodystrophyLipodistrofia asociada al VIH MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Germany;United Kingdom;France;Spain | |||
| 9 | EUCTR2006-005444-88-FR (EUCTR) | 15/02/2007 | 11/01/2007 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | HIV-associated lipodystrophy MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Germany;United Kingdom;France;Spain | |||
| 10 | EUCTR2006-005444-88-BE (EUCTR) | 16/01/2007 | 21/12/2006 | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation | HIV-associated lipodystrophy MedDRA version: 8.1;Level: LLT;Classification code 10024608;Term: Lipodystrophy | Product Name: TH9507 Product Code: TH9507 Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate | Theratechnologies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | France;Spain;Belgium;Germany;United Kingdom | |||
| 11 | NCT00123253 (ClinicalTrials.gov) | June 2005 | 20/7/2005 | TH9507 in Patients With HIV-Associated Lipodystrophy | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients With Excess of Abdominal Fat Accumulation | HIV Infections;Lipodystrophy | Drug: TH9507 | Theratechnologies | NULL | Completed | 18 Years | 65 Years | Both | 412 | Phase 3 | United States;Canada |