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    Summary
    EudraCT Number:2005-003797-25
    Sponsor's Protocol Code Number:GH100-013
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-09-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-003797-25
    A.3Full title of the trial
    A Multicenter, Randomized, Placebo-controlled, Double-blind Phase 2 Study to Evaluate the Efficacy and Safety of CJC-1295 administered for 12 weeks in HIV-Infected Patients with HIV-associated Visceral Obesity
    A.4.1Sponsor's protocol code numberGH100-013
    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 SponsorConjuChem, 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 Information not present in EudraCT
    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 nameCJC-1295
    D.3.2Product code CJC-1295
    D.3.4Pharmaceutical form Powder for solution 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.3.9.2Current sponsor codeCJC-1295
    D.3.9.3Other descriptive nameCJC-1295 TFA salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.IMP: 2
    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 Information not present in EudraCT
    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 nameDiluent for CJC-1295
    D.3.4Pharmaceutical form Solvent for parenteral use
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typediluent for CJC-1295 (PR1) and placebo
    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 for solution 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
    Patients 18 to 65 years old with HIV-associated visceral obesity, on a stable
    antiviral regimen for at least 6 weeks, with a viral load ≤1,000 copies/mL and
    CD4 count ≥200 cells/mm3, a body mass index (BMI) of ≥24 and ≤30 kg/m2,
    a waist-to-hip ratio of ≥0.95 in men or ≥0.90 in women, and a waist
    circumference of ≥90 cm in men or ≥85 cm in women.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess and compare the efficacy, pharmacokinetics, safety, and tolerability
    of CJC-1295 in patients with human immunodeficiency virus (HIV)-associated visceral obesity.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Able to provide written informed consent.
    2. Age 18 to 65 years.
    3. Documented HIV infection.
    4. HIV-associated visceral obesity as judged by the Investigator and meeting the
    following criteria:
    - Waist-to-hip ratio associated with increased risk for cardiovascular disease
    (≥0.95 in men and ≥0.90 in women),
    - Waist circumference ≥90 cm in men and ≥85 cm in women, and
    - Body mass index (BMI) ≥24 or ≤30 kg/m2, calculated as described in
    Section 6.1.6.
    5. Viral load ≤1,000 copies/mL.
    6. CD4 count ≥200 cells/mm3.
    7. On a stable antiviral regimen for at least 6 weeks prior to randomization.
    8. Women with childbearing potential must provide a negative pregnancy test prior to randomization and must use an adequate, double-barrier contraceptive method.
    (Non-childbearing potential is defined as post-menopausal for at least 1 year or
    surgical sterilization or hysterectomy at least 3 months before study start).
    9. Ability to understand study requirements and willingness to follow instructions,
    attend all required study visits, and undergo all planned procedures (including SC
    injections in the abdominal wall and drawing of blood samples).
    E.4Principal exclusion criteria
    1. Diabetes mellitus.
    2. Fasting triglyceride level ≥11.3 mmol/L (1,000 mg/dL).
    3. Unstable or untreated hypertension (>140/90 mmHg at screening).
    4. Active malignancies.
    5. BMI ≤24 or ≥30 kg/m2.
    6. Hemoglobin <9 g/dL.
    7. Use of GH or other GH secretagogues (except GHRH and GHRF, which may not
    have been used at all) within 3 months prior to randomization.
    8. Previous use of GHRH or GHRF.
    9. Use of (or anticipated need for) any of the following medications with 3 months prior to randomization:
    - systemic glucocorticoids,
    - megestrol acetate or other appetite stimulants,
    - general anorexigenic or weight-reducing agents, or
    - androgens, other than testosterone replacement therapy for male hypogonadism at
    physiological doses and on a stable regimen for at least 6 months prior to
    randomization.
    10. History of carpal tunnel syndrome, unless resolved by surgical release.
    11. Pregnant and/or breast-feeding women, or women within 3 months post-partum.
    12. Hepatic transaminases >3 times the upper limit of normal (ULN).
    13. Treatment with any investigational drug within 30 days prior to randomization.
    14. Abnormal 12-lead ECG, which, in the opinion of the Investigator, is clinically
    significant.
    15. Significant abnormality of the CT-scan (e.g., suspicion of tumor) as determined by
    the investigator.
    16. Major illness within the past 4 weeks that is, in the opinion of the Investigator,
    clinically serious, unstable, and/or uncontrolled, or that would make the patient
    unsuitable for entry in the study.
    17. Major surgery within 3 months prior to randomization and/or any surgery within
    2 weeks of randomization, unless approved by the sponsor’s medical monitor or
    designee.
    18. Donation of blood within 60 days of randomization.
    19. Dependence on or abuse of alcohol, narcotic, opioid, or other addictive substances.
    20. History of hypersensitivity to the study medication or to drugs with similar chemical structures.
    21. History or suspicion of unreliability, poor cooperation or non-compliance with
    medical treatment.
    22. Any concurrent disease or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.
    23. Previous enrollment in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint

    The primary efficacy endpoint is a percent change or absolute change in total IGF-1
    levels from baseline comparing active and placebo-treated patients after 12 weeks of treatment.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-09-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There is currently no approved treatment for HIV-associated lipodystrophy which could be offered to the patients at the end of the study. Further treatment and medical care of study participants will be at the discretion of their physicians and is part of the overall care of the HIV infection.
    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 Decision2005-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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