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    Summary
    EudraCT Number:2015-003261-28
    Sponsor's Protocol Code Number:CLN-PRO-V006
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-21
    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 ConcernedGermany - PEI
    A.2EudraCT number2015-003261-28
    A.3Full title of the trial
    An Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison with ePTFE Grafts as Conduits for Hemodialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Humacyte's Human Acellular Vessel with ePTFE Grafts for Hemodialysis Access
    A.3.2Name or abbreviated title of the trial where available
    HUMANITY
    A.4.1Sponsor's protocol code numberCLN-PRO-V006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02644941
    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 SponsorHumacyte, 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 supportHumacyte, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHumacyte, Inc.
    B.5.2Functional name of contact pointHumacyte Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address2525 E Highway NC 54
    B.5.3.2Town/ cityPO Box 12695; Durham, NC
    B.5.3.3Post code27713
    B.5.3.4CountryUnited States
    B.5.4Telephone number+01 919 313 9633
    B.5.5Fax number+01 919 238 1719
    B.5.6E-mailtente@humacyte.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHumacyte’s Human Acellular Vessel
    D.3.2Product code HAV
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    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 No
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Gore® PROPATEN® Vascular Graft or Bard® Impra® Vascular Graft
    D.2.1.1.2Name of the Marketing Authorisation holderW. L. Gore & Associates, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGore® PROPATEN® Vascular Graft or Bard® Impra® Vascular Graft
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    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) 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 No
    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 typeMedical device
    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
    End-stage renal disease (ESRD) requiring placement of an arteriovenous (AV) graft in the arm (upper- or forearm) to start or maintain hemodialysis therapy.
    E.1.1.1Medical condition in easily understood language
    Advanced kidney disease requiring placement of a tube in the arm (upper- or forearm) into which needles can be inserted to start or maintain hemodialysis therapy.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10042613
    E.1.2Term Surgical and medical procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066772
    E.1.2Term Vascular access operation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the Secondary Patency of the HAV with that of the ePTFE graft when used as a conduit for hemodialysis
    E.2.2Secondary objectives of the trial
    Efficacy
    To compare the Primary Patency of the HAV with that of the ePTFE graft.
    Safety
    To compare the rate of access-related infections for the HAV with that of the ePTFE graft.

    Other Secondary Objectives:
    Efficacy
    1. To compare the rate of interventions needed to maintain/restore patency of the HAV with that of the ePTFE graft.
    2. To compare the Primary Assisted Patency of the HAV with that of the ePTFE graft.
    3. To describe the histopathological remodeling of samples from HAV and ePTFE grafts.
    4. To compare the efficiency of dialysis with the HAV with that of
    the ePTFE graft in a subset of subjects.

    Safety
    1. To compare the safety and tolerability of the HAV with that of the ePTFE.
    2. To compare the relative rates of true aneurysm and pseudoaneurysm formation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with ESRD who are not, or who are no longer candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the arm (upper- or forearm) to start or maintain hemodialysis therapy.
    2. Either on hemodialysis or expected to start hemodialysis within 12 weeks of conduit formation.
    3. At least 18 years of age at Screening.
    4. Suitable anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow).
    5. Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 0 (within 35 days).
    6. Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 35 days).
    7. Adequate liver function prior to Day 0 (within 35 days), defined as both of the following:
    a. ≤2x upper limit of normal (ULN) for serum bilirubin, aspartate transaminase (AST),and alanine transaminase (ALT)
    b. ≤1.5 for International Normalized Ratio (INR) or prothrombin time (PT) ≤ 18 seconds unless the subject is taking an anticoagulant at the time
    8. Female subjects must be either:
    a. Of non-childbearing potential, which is defined as
    post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening)
    b. Or, of childbearing potential, in which case:
    i. Must have a negative serum or urine pregnancy test at Screening, and
    ii. Must agree to use at least one form of the following birth control methods for the duration of the study:
    1. Established use of oral, injectable or implanted hormonal methods of contraception
    2. Placement of an intrauterine device or intrauterine system
    3. Barrier methods of contraception:
    condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository
    9. Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.
    10. Life expectancy of at least 1 year.
    E.4Principal exclusion criteria
    1. History or evidence of severe peripheral vascular disease in the intended arm for implantation.
    2. Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of the planned implantation, unless the stenosis is corrected prior to study conduit implantation.
    3. Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
    4. Cancer that is actively being treated with a cytotoxic agent.
    5. Documented hyper-coagulable state.
    6. Bleeding diathesis.
    7. Active clinically significant immune mediated disease, not controlled by maintenance immunosuppression.
    a. Low dose glucocorticoid therapy (e.g. up to 10mg a day prednisone or prednisolone) is acceptable.
    b. High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
    c. Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
    d. The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
    i. tacrolimus or FK506 [Prograf]
    ii. mycophenolate mofetil [Cellcept],
    iii. cyclosporine [Sandimmune or Gengraf]
    iv. Sirolimus administered systemically (Sirolimus in drug eluting stents is NOT an exclusion)
    8. Anticipated renal transplant within 6 months.
    9. Venous outflow from study conduit cannot be placed more centrally than the venous outflow of any previous failed access in that extremity.
    10. Active local or systemic infection (white blood cells [WBC] > 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before implantation.
    11. Known serious allergy to planned antiplatelet agent.
    12. Pregnant women, or women intending to become pregnant during the course of the trial.
    13. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the study conduit.
    14. Previous enrollment in this study or any other study with the HAV.
    15. Employees of Humacyte and employees or relatives of the
    investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Time to loss of Secondary Patency from implantation
    * Defined as ‘the interval from the time of access placement until access abandonment’, i.e., patent with or without interventions
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    E.5.2Secondary end point(s)
    Efficacy
    Time to loss of Primary Patency from implantation
    * Defined as ‘the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency’, i.e., patent without interventions

    Safety
    Access-related infections
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 12
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    commercially available 6 mm ePTFE grafts
    E.8.2.4Number of treatment arms in the trial2
    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 EEA17
    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
    Germany
    Israel
    Poland
    Portugal
    United Kingdom
    United States
    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
    The end of the trial occurs when the last subject remaining on study has reached Month 60 follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months4
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    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)
    AV access will be determined by the investigator and may include the implanted conduit if it remains patent. Other care of the patients will be determined by the investigator.
    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 Decision2016-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-19
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