Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2018-003570-26
    Sponsor's Protocol Code Number:CLN-PRO-V011
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-12
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-003570-26
    A.3Full title of the trial
    A Phase 2 Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Vascular Access for Dialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Vascular Access for Dialysis
    A.4.1Sponsor's protocol code numberCLN-PRO-V011
    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 East NC Highway 54
    B.5.3.2Town/ cityDurham
    B.5.3.3Post codeNC 27713
    B.5.3.4CountryUnited States
    B.5.4Telephone number+19193139633
    B.5.5Fax number+19192381719
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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.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) for dialysis access.
    E.1.1.1Medical condition in easily understood language
    An advanced kidney disease requiring placement of a tube in the arm (upper- or forearm) into which needles for dialysis can be inserted.
    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 evaluate the safety, efficacy and immunogenicity over 3 months after implantation of HAVs manufactured using the commercial manufacturing system (Luna).
    E.2.2Secondary objectives of the trial
    To evaluate the long-term safety and efficacy of the HAV (manufactured with the Luna system) over a period of up to 36 months after implantation.
    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) for hemodialysis therapy.
    2. Already established on hemodialysis
    3. At least 18 years of age at Screening.
    4. Suitable arterial and venous 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 45 days).
    6. Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 45 days).
    7. Normal clotting (international normalized ration [INR] ≤ 1.5 or prothrombin time ≤ 18 sec unless the patient is taking an anticoagulant for an approved indication at the time of HAV implantation.
    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:
    - Established use of oral, injectable or implanted hormonal methods of contraception
    - Placement of an intrauterine device or intrauterine system
    - 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 HAV 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 as defined as either:
    a. a biochemical diagnosis (e.g. Factor V Leiden, Protein C deficiency, etc.) - OR –
    b. a clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g deep vein thrombosis, pulmonary embolism, etc.) within the 5 previous years.
    6. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g. von Willebrand disease, etc.).
    7. Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
    a. Low dose glucocorticoid therapy (e.g. up to 10 mg 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 HAV cannot be placed more centrally than the venous outflow of any previous failed access on 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 1 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 HAV.
    14. Previous enrollment in this study or any other study with HAV.
    15. Employees of Humacyte and employees or relatives of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoints:
    • Adverse events indicating possible mechanical failure or weakness of the HAV: anastomotic rupture, anastomotic bleeding, spontaneous HAV rupture, aneurysm, pseudoaneurysm, abnormal post cannulation hemostasis;
    • HAV infections;
    • Change from baseline of PRA and anti-HAV IgG levels (at 2 months);
    • All AEs/SAEs and adverse events of special interest.

    Primary Efficacy Endpoints:
    • Primary patency- defined as being maintained until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency’, i.e., patent without interventions;
    • Primary assisted patency- defined as being maintained until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of patent access’ i.e., patent without an intervention to clear a thrombus;
    • Secondary patency- defined as being maintained until access abandonment. Access abandonment defined as no remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months post implantation
    E.5.2Secondary end point(s)
    Secondary Safety Endpoints:
    • Adverse events indicating possible mechanical failure or weakness of the HAV: anastomotic rupture, anastomotic bleeding, spontaneous HAV rupture, aneurysm, pseudoaneurysm, abnormal post cannulation hemostasis;
    • HAV infections;
    • Change from baseline of PRA and anti-HAV IgG levels (at 12 months);
    • All AEs/SAEs until 12 months post implant, after that only SAEs associated with the HAV and adverse events of special interest.

    Secondary Efficacy Endpoints:
    • Primary patency;
    • Primary assisted patency;
    • Secondary patency;
    • Interventions required to achieve/maintain secondary patency;
    • Histopathological remodeling of any HAV (based on any samples collected).
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 month post implantation
    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 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. 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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 36 follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    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 Decision2019-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands