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.

• Register: EUCTR
• Last refreshed on: 26 June 2012
• Main ID: EUCTR2007-003233-16-FR
• Date of registration: 31/07/2007
• Prospective Registration: Yes
• Primary sponsor: Theratechnologies Inc.
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 19/09/2007
• Target sample size: 300
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003233-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, France, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
2. Signed informed consent before any trial-related activities.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Fasting blood glucose >8.33 mmol/L (150 mg/dL) at the end of the TH9507-CTR-1011 study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

HIV-associated lipodystrophy
MedDRA version: 9.1 Level: LLT Classification code 10024608 Term: Lipodystrophy

Intervention(s)

Product Name: Tesamorelin
Product Code: TH9507
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Tesamorelin
CAS Number: 218949-48-5
Current Sponsor code: TH9507
Other descriptive name: [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.1-
Pharmaceutical form of the placebo: Powder and solvent for suspension for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: This study is an extension to study TH9507-CTR-1011 (EudraCT number 2006-005444-88) to assess long-term safety of 2 mg/day TH9507 (26 weeks in a population previously receiving placebo in the TH9507-CTR-1011 study; 52 weeks for a subgroup of subjects previously receiving TH9507 in the TH9507-CTR-1011 study)

Primary end point(s): 1. Safety parameters as outlined in section 3.2.1 of the Protocol.
2. Efficacy endpoints:
(a) VAT, trunk fat and lipid profile measured through time;
(b) The percentage of subjects who gained back some or all VAT lost during the first 26 weeks, at Week 39 and Week 52.

Secondary Objective: 1. To assess over a 26-week placebo treatment period, the duration of effect on VAT, trunk fat and lipid profile following a 26-week treatment with 2 mg/day TH9507 as compared to baseline and Week 26;
2. To collect data on efficacy after a 52-week treatment with 2 mg/day TH9507

Secondary ID(s)

TH9507-CTR-1012