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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2007-000295-16
    Sponsor's Protocol Code Number:LX201-01
    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:2007-04-05
    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 number2007-000295-16
    A.3Full title of the trial
    A MULTI-CENTER, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL-GROUP DOSE-RANGING STUDY TO ASSESS THE EFFICACY AND SAFETY OF LX201 FOR PREVENTION OF CORNEAL ALLOGRAFT REJECTION EPISODES AND GRAFT FAILURE FOLLOWING PENETRATING KERATOPLASTY WITH LX201 IMPLANTATION IN SUBJECTS WHO ARE AT INCREASED IMMUNOLOGICAL RISK
    A.4.1Sponsor's protocol code numberLX201-01
    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 SponsorLux Biosciences, 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 numberEU/3/06/415
    D.3 Description of the IMP
    D.3.1Product nameCyclosporine A episcleral implant; 0.50 inch
    D.3.2Product code LX201 0.50''
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPImplant use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOSPORIN
    D.3.9.1CAS number 59865133
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Yes
    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 typesilicone implant containing 30% cyclosporine A by weight
    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 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 numberEU/3/06/415
    D.3 Description of the IMP
    D.3.1Product nameCyclosporine A episcleral implant; 0.75 inch
    D.3.2Product code LX201 0.75''
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPImplant use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOSPORIN
    D.3.9.1CAS number 59865133
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Yes
    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 typesilicone implant containing 30% cyclosporine A by weight
    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 placeboImplant
    D.8.4Route of administration of the placeboImplant use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient after penetrating keratoplasty who are at increased immunological risk for corneal allograft rejection episodes and/or graft failure
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011017
    E.1.2Term Corneal graft rejection
    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 and efficacy of LX201 in the prevention of corneal allograft rejection episodes or graft failure following penetrating keratoplasty with LX201 implantation in subjects who are at increased immunological risk for graft failure.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PROTOCOL LX201-01A; 10 August 2007
    CORNEAL SLIT-LAMP PHOTOGRAPH SUBSTUDY:
    ASSESSMENT OF CORNEAL NEOVASCULARIZATION IN SUBJECTS UNDERGOING TREATMENT WITH LX201 IMPLANTATION FOR THE PREVENTION OF CORNEAL ALLOGRAFT REJECTION EPISODES OR GRAFT FAILURE FOLLOWING PENETRATING KERATOPLASTY WITH LX201 IMPLANTATION IN SUBJECTS WHO ARE AT INCREASED IMMUNOLOGICAL RISK

    Corneal neovascularization is a strong risk factor for immune-mediated rejections after corneal transplantation. The angiogenic growth factor, vascular endothelial growth factor (VEGF), is an important growth factor responsible for corneal angiogenesis. Cyclosporine A inhibits VEGF signaling pathways and thus, LX201 may limit corneal neovascularization.
    The objective of this corneal slit lamp photograph substudy is to evaluate and quantify corneal neovascularization following penetrating keratoplasty in subjects treated with LX201 or a placebo implant.
    The primary analysis will be performed on photographs of the study eye.
    The endpoints are:
    • Vessel area
    • Maximal vessel length
    All sites participating in the LX201-01 study will be offered the opportunity to participate in this sub-study. All subjects randomized at participating sites will be eligible for inclusion in this sub-study.
    Slit lamp photographs of the study eye will be obtained prior to the implantation surgery (baseline), 1 day after surgery, Visit 1 (Week 1), Visit 5 (week 24) and Visit 12 (week 52). The photographs will be sent to the central reading center (Digital Image Laboratory in the Department of Ophthalmology at the University of Erlangen-Nürnberg/Germany).
    Vessel area and maximal vessel length will be quantified by automated digital image analysis.
    E.3Principal inclusion criteria
    1) Is a candidate for penetrating keratoplasty and is at increased immunological risk for rejection episodes or graft failure, as evidenced by one or more of the following:
    a) Stromal corneal vascularization in ≥ 1 quadrant, extending 2 mm or more
    from the limbus.
    b) A verifiable history of graft failure due to rejection. Subject history can include graft failure due to rejection, or a history of graft loss preceded by a verifiable rejection episode.
    2) Conjunctiva must be suitable for implantation with the study device (i.e., sufficient to cover the implant and minimize the potential for dehiscence or extrusion)
    3) Subjects 18 years of age or older
    4) Physical condition suitable for undergoing surgery, as evidenced by medical history, physical examination, vital signs and 12-lead ECG.
    E.4Principal exclusion criteria
    1) Any condition that would greatly increase the risk of non-immunological graft failure such as Stevens-Johnson syndrome, xerophthalmia or severe exposure keratitis.
    2) Schirmer’s test ≤ 5 mm within 5 minutes with eyes closed, using anesthesia
    3) Clinical evidence of limbal stem cell deficiency
    4) History of or active herpes simplex virus keratitis or other acute corneal infection
    5) Uncontrolled glaucoma as evidenced by an intraocular pressure of >21 mmHg while on maximal medical therapy
    6) Hypotony as evidenced by an intraocular pressure of < 6 mmHg in the study eye.
    7) Clinically suspected or confirmed ocular lymphoma
    8) Treatment with a systemic immunosuppressive regimen within 30 days prior to study implant placement
    9) Previous exposure to cyclosporine (any formulation) within 14 days prior to study implant placement or known contraindication to administration of cyclosporine.
    10) Treatment with systemic prednisone (or its equivalent) of > 10 mg daily within 30 days prior to study implant placement
    11) Any implantable corticosteroid-eluting device (e.g., Retisert™, Posurdex®, Medidur™, I-vation™ TA intravitreal implant)
    12) Subjects who periodically require high-dose systemic steroid treatment (e.g., for exacerbation of chronic obstructive pulmonary disease).
    13) Subjects who have received treatment with a monoclonal antibody or any other biologic therapy within the previous 30 days or alemtuzumab within the previous 12 months
    14) Treatment with silicone oil within 12 months prior to study implant placement
    15) History of herpes zoster or varicella infection within 6 weeks prior to enrollment, or chicken pox exposure within 21 days before enrollment
    16) Seropositivity for human immunodeficiency virus (HIV)
    17) Recipients of a solid organ transplant
    18) Currently participating in another clinical trial with an investigational agent in the 30 days prior to study participation and/or has not recovered from any reversible effects or side effects of prior investigational agent
    19) Currently pregnant or lactating. Sexually active women of childbearing potential or less than 1 year post-menopausal and sexually active men who are not surgically sterile must use a reliable form of birth control during study treatment and for at least 3 months after the last dose of study drug. Surgically sterile females are not considered to be of childbearing potential. Reliable forms of birth control include oral or depot contraceptives and double-barrier methods.
    20) Active, extraocular and/or systemic infection requiring the prolonged or chronic use of antimicrobial agents or the presence of active hepatitis A, B or C, as determined by positive serology results for anti-HAV IgM, hepatitis B surface antigen or anti-HCV.
    21) Patients with anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 2500 mm3), thrombocytopenia (platelet count < 80,000 mm3), polycythemia (Hct > 54% [male] or Hct > 49% [female]), neutropenia (ANC < 2500 mm3) or clinically significant coagulopathy
    22) Current malignancy or a history of malignancy (within the previous 5 years) except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix that has been treated successfully
    23) Active peptic ulcer disease
    24) Co-morbid conditions that require immunosuppression
    25) Medically significant co-morbid conditions that substantially impair normal activities or any medical condition that would likely have an impact on the subject’s ability to comply with the study visit schedule.
    26) Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects experiencing efficacy failure within 52 weeks following penetrating keratoplasty with LX201/placebo implantation where efficacy failure is defined as either an episode of graft rejection or graft failure.
    The presence of one or more of the following will constitute evidence of rejection:
    • ≥ 1 keratic precipitate on the donor endothelium
    • subepithelial infiltrates
    • increased corneal thickness without aqueous cells
    • increased aqueous cells above the subject’s post-operative background level
    without an increase in corneal thickness
    • increased corneal thickness and increased aqueous cells
    • an endothelial rejection line of any length
    • inflammatory cells in the corneal stroma
    Grafts that do not clear within 10 days of surgery will be defined as primary donor failures. Grafts that clear within 10 days after surgery and later become cloudy for a continuous period of ≥ 3 months will be declared a failure.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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) 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 Yes
    E.8.1.4Double blind No
    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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA8
    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
    N/A
    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 months8
    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) 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 350
    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)
    At week 52 visit all subjects will undergo explantation of the study drug. A follow up visit will be conducted 3 months after study implant explantation for all subjects. Should the study implant be explanted prior to week 52, the date and reason shall be recorded in the CRF. Subjects who have the study drug explanted prior to week 52 will continue to be followed for secondary efficacy and safety assessments through week 52 or for 3 months following the date of explantation, whichever is later.
    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 Decision2007-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-22
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