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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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003233-16-FR
Enrollment
300
Registered
2007-07-31
Start date
2007-09-19
Completion date
Unknown
Last updated
2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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: TH950

Sponsors

Theratechnologies Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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);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 ;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.—

Countries

Belgium, France, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026