Tesamorelin ( DrugBank: Tesamorelin )


2 diseases
IDDisease name (Link within this page)Number of trials
78Hypopituitarism1
265Lipodystrophy8

78. Hypopituitarism


Clinical trials : 494 Drugs : 385 - (DrugBank : 49) / Drug target genes : 44 - Drug target pathways : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03226821
(ClinicalTrials.gov)
February 7, 201820/7/2017Body Composition and Adipose Tissue in HIVBody Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin TherapyHIV Lipodystrophy Syndrome;Growth Hormone Deficiency;Body CompositionDrug: TesamorelinColumbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years68 YearsAll24Phase 4United States

265. Lipodystrophy


Clinical trials : 116 Drugs : 170 - (DrugBank : 61) / Drug target genes : 26 - Drug target pathways : 97
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03226821
(ClinicalTrials.gov)
February 7, 201820/7/2017Body Composition and Adipose Tissue in HIVBody Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin TherapyHIV Lipodystrophy Syndrome;Growth Hormone Deficiency;Body CompositionDrug: TesamorelinColumbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years68 YearsAll24Phase 4United States
2NCT01788462
(ClinicalTrials.gov)
May 20121/2/2013Egrifta Replacement and Sleep Disordered BreathingEgrifta Replacement and Sleep Disordered BreathingLipodystrophyDrug: Tesamorelin (Egrifta)Johns Hopkins UniversityNULLWithdrawn18 Years75 YearsAll0N/AUnited States
3NCT01263717
(ClinicalTrials.gov)
December 201016/12/2010Effects of Growth Hormone Releasing Hormone in HIVEffects of Growth Hormone Releasing Hormone on Fat Redistribution, Cardiovascular Indices, and Growth Hormone Secretion in HIV LipodystrophyHIV;HIV LipodystrophyDrug: tesamorelin;Drug: placeboMassachusetts General HospitalNULLCompleted18 Years65 YearsAll54N/AUnited States
4EUCTR2007-003233-16-ES
(EUCTR)
11/12/200722/10/2007A 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.NULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
5EUCTR2007-003233-16-GB
(EUCTR)
29/11/200702/08/2007A 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.NULLNot 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): noFrance;Spain;Belgium;United Kingdom
6EUCTR2007-003233-16-FR
(EUCTR)
19/09/200731/07/2007A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
7EUCTR2007-003233-16-BE
(EUCTR)
05/09/200722/08/2007A 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.NULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Belgium;France;Spain
8NCT00608023
(ClinicalTrials.gov)
August 200723/1/2008TH9507 Extension Study in Patients With HIV- Associated LipodystrophyA 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 AccumulationLipodystrophy;HIV InfectionsDrug: Tesamorelin;Drug: Placebo for TesamorelinTheratechnologiesNULLCompleted18 Years65 YearsAll263Phase 3United States;Belgium;Canada;France;Spain;United Kingdom