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    Summary
    EudraCT Number:2006-003700-18
    Sponsor's Protocol Code Number:20060131
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2006-003700-18
    A.3Full title of the trial
    A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura
    A.4.1Sponsor's protocol code number20060131
    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 SponsorAmgen 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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/008/05
    D.3 Description of the IMP
    D.3.1Product nameAMG 531
    D.3.2Product code AMG 531
    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 INNAMG 531
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immune (idiopathic) thrombocytopenic purpura (ITP)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10021245
    E.1.2Term Idiopathic thrombocytopenic purpura
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to compare the ability of AMG 531 versus medical standard of care (SOC) to prevent a splenectomy and to provide a durable treatment option for immune (idiopathic) thrombocytopenic purpura (ITP) non-splenectomized adult subjects during the 52- week treatment period.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to observe the impact of AMG 531 on various ITP symptoms and platelet parameters compared to medical SOC for ITP. These include the time to splenectomy, platelet response, and the change in ITP Patient Assessment Questionnaire (PAQ) Physical Health domains of Symptoms, Bother, Activity, and Fatigue.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject is = 18 years of age.
    - Subject has a diagnosis of ITP according to ASH guidelines.
    - If subject is > 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of ITP.
    - Subject has received at least 1 prior therapy for ITP.
    - Subject has a platelet count < 50 x 109/L or their platelet count falls to < 50 x 109/L during or after a clinically- indicated taper or discontinuation of current ITP therapy.
    - Before any study- specific procedure, the appropriate written informed consent must be obtained (see Section 12.1).
    E.4Principal exclusion criteria
    - Subject has had a splenectomy for any reason.
    - Subject has an active malignancy.
    - Subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma in situ, with treatment or active disease within 5 years.
    - Subject has a known history of bone marrow stem cell disorder,
    • Abnormal bone marrow findings, other than those typical of ITP, must be approved by Amgen before a subject may be enrolled in the study.
    - Subject has participated in any study evaluating PEG- rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531, or a thrombopoietic protein.
    - Subject is receiving other investigational agents or procedures.
    - Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study.
    - Subject is pregnant or breast feeding.
    - Subject is not using adequate contraceptive precautions.
    - Subject has known sensitivity to any recombinant E coli- derived product.
    - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative.
    - Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    This study has 2 primary endpoints, 1 related to splenectomy and the other related to treatment failure. The first primary endpoint will be the number of subjects undergoing a splenectomy by treatment group during the 52-week treatment period. The second primary endpoint will be the number of subjects with a treatment failure during the 52-week treatment period. Treatment failure is defined as:

    • a lack of efficacy defined as platelet count < 20 x 109/L for 4 consecutive weeks at the highest recommended dose and schedule (AMG 531 – 10 ug/kg weekly; medical SOC for ITP – apply standard institutional practices or therapeutic guidelines); or,

    • a major bleeding event; or,

    • a change in therapy due to an intolerable side effect or bleeding symptoms (including a minor bleeding event).
    A minor bleeding event is defined as “ dry” or “ wet” purpura (eg, petechiae, mucosal bleeding from the gums or nose). A major bleeding event is defined as a hemorrhage (eg, upper or lower gastrointestinal tract, genitourinary tract or central nervous system). The primary statistical hypothesis will be that the corresponding rates in the AMG 531 arm will be lower compared to the medical SOC for ITP arm in both the proportion of subjects having a splenectomy and the proportion of subjects with a treatment failure within the 52-week treatment period. The study will declare a success with AMG 531 treatment if the tests for both primary efficacy endpoints are statistically significant in favor of AMG 531 arm over the medical SOC for ITP arm.
    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 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 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) 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 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 Yes
    E.8.2.3.1Comparator description
    Standard of Care as defined by international treatment guidelines and local medical practice
    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.8.5.1Number of sites anticipated in the EEA89
    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 years2
    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 years2
    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.1.3Elderly (>=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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 210
    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 Decision2006-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-05
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