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    Summary
    EudraCT Number:2015-002072-24
    Sponsor's Protocol Code Number:15VR7
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-12
    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 number2015-002072-24
    A.3Full title of the trial
    An Open-Label, Dose Finding, International Phase 2 Study with Once Monthly Subcutaneous Somavaratan (VRS-317) in Adult Growth Hormone Deficiency (GHD)
    Versartis International Trial in Adults with Long Acting Growth Hormone.
    The VITAL study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long Acting Growth Hormone (Somavaratan) clinical study in adults to determine effective dose.
    A.3.2Name or abbreviated title of the trial where available
    Versartis International Trial in Adults with Long Acting Growth Hormone (VITAL)
    A.4.1Sponsor's protocol code number15VR7
    A.5.4Other Identifiers
    Name:IND NumberNumber:108471
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVersartis 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 supportVersartis Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPremier Research
    B.5.2Functional name of contact pointJessica Merryfield
    B.5.3 Address:
    B.5.3.1Street AddressCentre Square West, 1500 Market Street, Suite 3500
    B.5.3.2Town/ cityPhiladelphia
    B.5.3.3Post codePA 19102
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1678362 0916
    B.5.6E-mailJessica.Merryfield@premier-research.com
    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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/074/13
    D.3 Description of the IMP
    D.3.1Product nameSomavaratan
    D.3.2Product code VRS-317
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNSomavaratan
    D.3.9.1CAS number 1448335-08-7
    D.3.9.3Other descriptive nameVRS-317
    D.3.9.4EV Substance CodeSUB31926
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Growth Hormone Deficiency in adults
    E.1.1.1Medical condition in easily understood language
    Growth Hormone Deficiency, GHD
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the safety of individualized dosing of Somavaratan for up to five months as assessed by review of the accumulated safety data in each treatment cohort
    •To evaluate the starting doses of Somavaratan for each cohort as measured by the proportion of subjects who achieve normalization of IGF-I SDS response (reference range of -2.00 to 2.00 SDS) during the first dosing interval (one month after the first dose)
    •To evaluate the dose titration plan of Somavaratan for each cohort as measured by the proportion of subjects who achieve a mean IGF-I SDS (based on pre-dose and 7 days after dosing values) within the defined target range of 0 to 1.50 after each dose titration
    •To determine whether IGF-I response over the 30 day dosing interval can be determined by using the SDS of the mean of IGF-I values from pre-dose and 7 days after dosing
    E.2.2Secondary objectives of the trial
    •To evaluate the immunogenicity of Somavaratan by measurement of serum anti-drug antibody (ADA) titers and detection of neutralizing antibodies (NAb)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male subjects with age 23 to 70 years (inclusive).
    2. Female subjects of childbearing potential must agree to use appropriate contraceptive methods during the study and continue this method for at least one month after their study completion.
    3. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening.
    4. Subjects must have a documented medical history of GHD during adulthood, according to established guidelines (confirmatory testing
    should be done to document persistence of childhood onset GHD into adulthood if necessary). Acceptable diagnostic criteria include:
    - insulin tolerance test (ITT): peak hGH ≤ 5.0 ng/mL
    - arginine alone: peak hGH ≤ 1.4 ng/mL
    - arginine + growth-hormone-releasing hormone
    - glucagon stimulation test: peak hGH ≤ 3.0 ng/mL
    OR
    - at least 3 pituitary hormone deficiencies and a low IGF-I for age/gender

    For arginine + GHRH stimulation test, peak hGH limit is based upon body mass index as follows: ≤ 11.0 ng/mL for BMI < 25 kg/m2; ≤ 8.0 ng/mL for 25 ≤ BMI < 30 kg/m2; ≤ 4.0 ng/mL for BMI ≥ 30 kg/m2.
    Current height may be used to determine BMI if BMI is not available from the date of the stimulation test.
    If documented confirmation is not available, GH stimulation test may be performed at Screening (subjects receiving daily rhGH therapy must be withdrawn for at least 7 days prior to testing).
    5. Subjects taking other hormone replacement therapy for pituitary failure must have been on a stable course of treatment for at least 3 months prior to Screening.
    6. Subjects with underlying disorders responsible for the subject's GHD must have been clinically stable for at least 6 months prior to Screening.
    7. If a subject is currently receiving daily recombinant human growth hormone (rhGH) injections for treatment of GHD, must agree to stop taking prescribed daily rhGH therapy for the washout period of 14 days minimum.
    8. Subjects must agree to inform the prescribing physician of study involvement, and the Investigator, prior to initiating a new medication (prescription or over-the-counter).
    9. Subjects must provide signed informed consent.
    10. Subjects must have a BMI (kg/m2) between 19.0 and 35.0 (inclusive).
    E.4Principal exclusion criteria
    1.Subjects with a documented history of diabetes mellitus or inadequate glucose control as defined by a historical or Screening value of:
    •FPG > 126 mg/dL (7 mM), or
    •HbA1c ≥ 6.5%
    2.Subjects with untreated adrenal insufficiency. Adrenal insufficiency will be screened by morning serum cortisol followed by ACTH stimulation test for subjects without documented history of adrenal insufficiency.
    3.Subjects with free thyroxine outside the normal reference range.
    4.Subjects currently taking oral glucocorticoids, except for physiological maintenance doses of oral glucocorticoids in subjects with multiple pituitary hormone deficiencies.
    5.Subjects with current significant cardiovascular disease, heart insufficiency of NYHA class > 2.
    6.Subjects with current significant cerebrovascular, pulmonary, neurological (not considered related to GHD), renal, inflammatory, or hepatobiliary disease.
    7.Subjects with current papilledema.
    8.Subjects with a history of persistent (unresolved without medical intervention) or recurring migraines.
    9.Subjects with current edema (≥ CTCAE Grade 2).
    10.Subjects with current drug or alcohol abuse.
    11.Subjects with a documented history of HIV, current HBV or HCV infection (testing not required).
    12.Subjects with a prior history of malignancy or abnormal results of any routine cancer screening tests, excluding adequately treated non-melanoma skin cancers or adequately treated in situ carcinoma of the cervix.
    13.Women who are pregnant or breastfeeding.
    14.Subjects treated with an investigational drug within 30 days prior to Screening.
    15.Subjects with a significant abnormality in Screening laboratory results as interpreted by the Investigator and/or the Medical Monitor.
    E.5 End points
    E.5.1Primary end point(s)
    1. IGF-I SDS levels within therapeutic range after 1st dose
    2. IGF-I SDS levels within target range following each dose
    3. Compare mean IGF-I from 2 values vs mean IGF-I from 4 values
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Predose and Day 7 following 1st dose
    2. Predose and Day 7 following each dose
    3. Predose and Days 7, 21 and 30 following each dose
    E.5.2Secondary end point(s)
    1. Serum anti-drug antibody titers
    2. Serum neutralising antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Prior to each dose and at end of study
    2. Prior to each dose and at end of study
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Germany
    United Kingdom
    United States
    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
    End of trial will be last visit of last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    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 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.1.2.1Number of subjects for this age range: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 40
    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)
    Patients who complete the study will be offered participation in a long-term, open label extension study with Somavaratan.
    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 Decision2015-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-06
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