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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2007-007725-46
    Sponsor's Protocol Code Number:ASBI 307
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-07
    Trial results View 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2007-007725-46
    A.3Full title of the trial
    A Phase 2b, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SUN11031 for Injection Administered Subcutaneously Twice Daily for 12 Weeks to Subjects Having Cachexia Associated with Chronic Obstructive Pulmonary Disease
    A.4.1Sponsor's protocol code numberASBI 307
    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 SponsorAsubio Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 nameSUN11031 for Injection
    D.3.2Product code SUN11031
    D.3.4Pharmaceutical form Powder and solvent 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.3.8INN - Proposed INNSUN11031
    D.3.9.1CAS number 258279-04-8
    D.3.9.2Current sponsor codeSUN11031
    D.3.9.3Other descriptive nameSynthetic Human Ghrelin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7 / 14
    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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typea polypeptide produced by condensation of a chemically synthesized N-terminal fragment , which confers biologic activity, with a C-terminal fragment prepared by genetic recombination
    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 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
    Cachexia associated with chronic obstructive pulmonary disease
    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 evaluate the effect of SUN11031 for injection versus placebo administered subcutaneously to subjects with cachexia associated with chronic obstructive pulmonary disease (COPD) on the change in distance walked during the six-minute walk test (6MWT) between Baseline (Days -6 to -3) and the end of 12 weeks of dosing
    E.2.2Secondary objectives of the trial
    •To evaluate the effect of SUN11031 for injection versus placebo administered subcutaneously to subjects with cachexia associated with COPD on the change in distance walked during the 6MWT between Baseline and Days 29 and 57 after 4 and 8 weeks of dosing, respectively
    • To evaluate the safety of SUN11031 for injection administered subcutaneously twice daily for 12 consecutive weeks in subjects with cachexia associated with COPD
    • To explore the effect of SUN11031 for injection administered subcutaneously to subjects with cachexia associated with COPD on changes in body weight, body composition, appetite, dyspnea, functional physical performance, and in laboratory indicators of nutritional status
    • To evaluate the pharmacokinetics of SUN11031 for injection and the associated expression of the biomarkers growth hormone, cortisol, insulin-like growth factor-1, C-reactive protein , tumor necrosis factor-alpha, and interleukin-6 following subcutaneous administration to subjects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or non-pregnant female subjects ≥50 years of age with a clinical diagnosis of COPD for ≥12 months
    2. A distance walked of ≥100 but ≤450 meters during the 6MWT performed at Screening
    3. A clinical diagnosis of COPD based on a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of <70%, and an FEV1 of 20% to 79% predicted
    4. COPD that has been stable, meaning that any reduction in FEV1 should be less than 10% between Screening and Baseline (Days -6 to -3), and that symptoms of COPD and concomitant medication use are stable, in the opinion of the Investigator
    5. Chest x-ray within the past year that is compatible with COPD
    6. Current or previous smokers, with a cumulative smoking history of at least 10 pack-years or exposure to indoor air pollution from biomass cooking and heating
    7. Documented involuntary nonedematous weight loss >5% of subject’s usual body weight over the past 12 months or body mass index (BMI) ≤21 kg/m2 for males or BMI ≤20 kg/m2 for females (Prescott et al. Eur Respir J. 2002 Sep;20(3):539-44; Celli et al. N Engl J Med. 2004 Mar 4;350(10):1005-12).
    8. Female subjects who are clinically sterile (eg, either postmenopausal or have undergone a tubal ligation or hysterectomy), or are practicing a medically acceptable method of birth control (eg, oral, transdermal, implantable, or injectable contraceptive medications; double-barrier method or intrauterine device [IUD])
    9. Capable of understanding and complying with the requirements of the study and willing to sign the informed consent form. (If required by the relevant ethical, legal, or regulatory authorities, a Health Insurance Portability and Accountability Act of 1996 [HIPAA] and/or other privacy consent must also be signed.)
    E.4Principal exclusion criteria
    1. A BMI >26 kg/m2
    2. Use, over a total of 7 or more days, of parenteral corticosteroids at a dose equivalent to prednisone at ≥5 mg/day or oral corticosteroids at a dose equivalent to prednisone at >10 mg/day within the 2 months before Screening; however, subjects will be allowed to participate if on stable doses equivalent to prednisone at ≤10 mg/day for at least 2 months before Screening, and are planning to remain on the same stable dose throughout thestudy.
    3. Plan to participate in a pulmonary rehabilitation program during the study
    4. Weight loss that is considered to be, in the opinion of the Investigator, the result of food deprivation
    5. Unintended weight loss that may be due to disease other than COPD
    6. Unable or unwilling to be trained to self-administer the study drug by subcutaneous injection twice daily, and for whom arrangements cannot be made for a third party to reliably administer the injections
    7. Severe anemia (hemoglobin ≤8 g/dL)
    8. COPD exacerbation defined as a Type 1 or 2 exacerbation according to the Winnipeg criteria (see Appendix 19), acute infection, or prolonged fever within 4 weeks before Screening
    9. Currently undergoing treatment or evaluation for cancer, or has a history of treatment for cancer within the past 3 years, exception being nonmelanoma skin cancer (basal cell or squamous cell carcinoma of the skin) and carcinoma in situ of the cervix
    10. Type I or type II diabetes mellitus or a fasting serum glucose of ≥115 mg/dL (6.4 mmol/L) (fasting is overnight)
    11. Serious disease or conditions that would interfere with the subject's ability to complete the functional measures included in this protocol; or any illness that, in the opinion of the Investigator, might interfere with the results of the study or the subject’s ability to participate
    12. Pulmonary embolism, deep venous thrombosis, or clinically significant primary pulmonary hypertension within the past 6 months
    13. Significant ischemic heart disease or chronic heart failure (New York Heart Association [NYHA] Class IV cardiac disease)
    14. Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >110 mmHg)
    15. A history of symptomatic orthostatic hypotension or syncope; or orthostatic hypotension on Screening or Baseline (Days -6 to -3) (orthostatic hypotension is defined as a decrease in systolic blood pressure by ≥20 mmHg measured after 2 minutes in a standing position compared with the systolic blood pressure measured after 10 minutes in a supine position)
    16. Evidence of ascites, pleural effusion, or lower extremity edema
    17. Severe vitamin D deficiency (25-hydroxyvitamin D <10 ng/mL)
    18. Known mechanical obstruction of the alimentary tract and/or malabsorption
    19. Dental or swallowing problems that may have a negative effect on food intake
    20. Serum creatinine >2.5 mg/dL; or alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyltransferase (GGT) >3 times the upper limit of normal (ULN), or bilirubin >2.5 mg/dL
    21. A diagnosis of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
    22. Use of any prescription drugs and non-prescription drugs/herbs that cause weight loss or affect appetite and absorption or that may cause nausea; or the use of appetite-promoting or anabolic medications within 15 days before Screening
    23. A history of alcohol or drug abuse that, in the opinion of the Investigator, would interfere with the subject’s ability to comply with the dosing schedule and protocol-specified requirements
    24. Hypersensitive to any component of SUN11031 for injection, or participated at any time in any study in which SUN11031 was administered
    25. Received an investigational drug or product, or participated in a drug study within 30 days before Screening
    26. Non-ambulatory or unwilling to cooperate fully with the Investigator or a designee, or unwilling or unable to comply with study requirements, such as all assessments required by the protocol, including completion of measures for functional capacity and pulmonary function, or frequent blood sampling and meal instructions; or unable or unwilling to attend all study visits
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from Baseline (Days -6 to -3) to Day 85 in the distance walked during the 6MWT for each of the two active treatment groups compared to placebo for subjects in the Intent-to-Treat (ITT) population
    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 Yes
    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 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 No
    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 months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months22
    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) Yes
    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 100
    F.4.2.2In the whole clinical trial 225
    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)
    Expected normal treatment
    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 Decision2009-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
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