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    The EU Clinical Trials Register currently displays   41231   clinical trials with a EudraCT protocol, of which   6758   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2006-005444-88
    Sponsor's Protocol Code Number:TH9507-CTR-1011
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-01-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2006-005444-88
    A.3Full title of the trial
    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.4.1Sponsor's protocol code numberTH9507-CTR-1011
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTheratechnologies Inc.
    B.1.3.4CountryCanada
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTH9507
    D.3.2Product code TH9507
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 218949-48-5
    D.3.9.2Current sponsor codeTH9507
    D.3.9.3Other descriptive name[N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV-associated lipodystrophy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10024608
    E.1.2Term Lipodystrophy
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate a reduction in visceral adipose tissue (VAT) versus placebo.
    E.2.2Secondary objectives of the trial
    1. To demonstrate the efficacy of TH9507 versus placebo in:
    a. Subject reported outcomes related to body image
    b. Total cholesterol/ HDL-Cholesterol ratio and triglycerides levels
    c. IGF-1 levels
    2. To characterize the safety profile of TH9507 treatment in HIV subjects with excess abdominal fat accumulation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects (male or female) aged 18 to 65 inclusive;
    2. HIV positive with CD4 cell counts > 100 cells/mm3 and viral load < 10 000 copies/mL within 8 weeks prior to randomization;
    3. On stable ART regimen for at least 8 weeks prior to randomization;
    4. Have evidence of excess abdominal fat accumulation defined by the following anthropometrics cut off values, considered by the Investigator to be part of the HIV-associated lipodystrophy syndrome and occurring in the context of the treatment of HIV disease:
    a. For males: Waist circumference greater than or equal to 95 cm and waist/hip ratio greater than or equal to 0.94
    b. For females: Waist circumference greater than or equal to 94 cm and waist/hip ratio greater than or equal to 0.88;
    5. Female subjects of childbearing potential are eligible only if they are not pregnant (negative pregnancy test) or lactating and they are:
    a. pre-menopausal and using an acceptable form of birth control prior to study entry and for at least 2 months after completing the treatment,
    b. or surgically sterilized (tubal ligation or hysterectomy),
    c. or post-menopausal with no menses for > 1 year;
    6. For all female subjects, normal mammography within 6 months of randomization;
    7. Have sufficient literacy to read, understand and complete the self-administered patient-reported outcomes questionnaire, as well as all study questionnaires;
    8. Signed informed consent before any trial-related activities.
    E.4Principal exclusion criteria
    1. Body Mass Index less than or equal to 20 kg/m2;
    2. Opportunistic infection or HIV-related disease within 3 months of randomization;
    3. History of malignancy of any organ or tissue (with the exception of basal cell carcinoma of the skin, in situ carcinoma of the cervix and stable Kaposi not having required treatment for the past 6 months);
    4. For male subjects, suspicion of cancer by prostate examination and PSA > 5 ng/ml at screening;
    5. For female subjects, history of breast cancer or proven maternal family history of breast cancer;
    6. Hypopituitarism, or history of pituitary tumor/surgery, head irradiation or head trauma that has affected the somatotrophic axis;
    7. Untreated hypothyroidism;
    8. Co-morbid condition that will not allow the subject to complete the study as per the Investigator’s judgment;
    9. Evidence of the following at screening:
    a. Hepatic dysfunction: ALT or AST greater than or equal to 3 x ULN
    b. Renal dysfunction: serum creatinine > 133 micromol/L (1.5 mg/dL)
    c. Anemia: hemoglobin more than 20 g/L below LLN
    d. Fasting blood glucose greater than or equal to 8.33 mmol/L (150 mg/dL)
    e. Lipid metabolism dysfunction: fasting triglycerides > 11.3 mmol/L (0.99 g/dL);
    10. Uncontrolled hypertension defined as systolic pressure > 140 mmHg and diastolic pressure > 90 mmHg;
    11. Use of any hypoglycemic or insulin-sensitizing agent within 6 months of randomization (except subjects previously treated with insulin during pregnancy and where insulin was not required after delivery) and throughout the study;
    12. Change in anti-hyperlipemic regimen within 3 months prior to randomization; Use of stable anti-hyperlipemic regimen during the study is not exclusionary;
    13. Supraphysiological dose of testosterone [e.g. > 10 mg/day of transdermal testosterone, > 10 g/day of topical/gel testosterone, or > 100 mg/week of IM testosterone (e.g. 200 mg/2 weeks, 300 mg/3 weeks or 400 mg/month), or their equivalent] within 6 months prior to randomization and throughout the study;
    14. Change in physiological testosterone regimen within 6 months prior to randomization. Use of stable physiologic testosterone during the study is not exclusionary;
    15. Use of anabolic steroids within 6 months prior to randomization and throughout the study;
    16. Therapy with estrogen within 2 months prior to randomization and throughout the study;
    17. Use of any prescription weight loss agent (anorectics, anorexigenics or anti-obesity agents), appetite stimulant or antianorectic agents within 3 months prior to randomization and throughout the study;
    18. Use of any experimental or marketed GH or GRF/GHRH products, GH secretagogues, IGF-1 or IGFBP-3 within 6 months prior to randomization and throughout the study;
    19. Prior use of TH9507;
    20. Drug or alcohol dependence within 6 months prior to randomization;
    21. Use of methadone within 6 months prior to randomization;
    22. Participation in a clinical trial with any investigational drug/device within 30 days prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percent change from baseline to week 26 in VAT (Visceral Adipose Tissue)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 400
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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