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Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure (CUPID)

19. August 2014 aktualisiert von: Celladon Corporation

A Phase 1/2 Trial of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects With Heart Failure in Two Stages (Open-Label, Sequential Dose-Escalation Cohorts and Randomized, Double-Blind, Placebo-Controlled, Parallel Cohorts)

The study is divided into 2 parts. In the first part, the safety of the gene transfer agent MYDICAR® will be evaluated. In the second part, the ability of MYDICAR® to improve heart function will be studied.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The American Heart Association (AHA) 2006 update on heart disease reported that 5 million Americans are believed to have symptomatic heart failure (HF), and 550,000 patients are newly diagnosed each year. The estimated direct and indirect cost of HF in the United States (U.S.) for 2006 will be ~$29.6 billion. Heart failure is a disabling chronic disease and the most frequent discharge diagnosis for hospitalization among older adults. Despite the significant resources expended on the treatment of this disease, outcomes remain poor. The five-year survival for individuals diagnosed with heart failure is less than 50%, and in end-stage heart failure, the one-year survival may be as low as 25% regardless of medical therapy.

Recent studies suggest that the failing heart is not refractory to treatment, as was previously believed. For example, the observation that a small percentage of subjects with left ventricular assist devices (LVADs) can be permanently weaned from their device strongly suggests that damaged hearts are capable of recovering lost function.

Clinical studies of MYDICAR® have not yet been conducted in humans. Celladon Corporation (Celladon) proposes to investigate gene transfer as a method to restore SERCA2a function in heart failure (HF) patients using a recombinant adeno-associated viral vector (AAV), which consists of an AAV serotype 1 capsid and contains the human SERCA2a complementary DNA (cDNA) flanked by Inverted Terminal Repeats (ITR) derived from AAV serotype 2 (AAV1/SERCA2a). MYDICAR® refers to AAV1/SERCA2a drug product intended for administration by percutaneous delivery.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

51

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • San Diego, California, Vereinigte Staaten, 92123
        • San Diego Cardiac Center
      • San Diego, California, Vereinigte Staaten, 92103
        • University of California at San Diego Medical Center
    • Florida
      • Gainesville, Florida, Vereinigte Staaten, 32608
        • Shands Hospital at University of Florida
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Northwestern University
      • Chicago, Illinois, Vereinigte Staaten, 60637
        • University Of Chicago Medical Center
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten, 64111
        • Mid America Heart Institute, Saint Luke's Hospital
      • St. Louis, Missouri, Vereinigte Staaten, 63110
        • St. Louis University Hospital
    • New Jersey
      • Newark, New Jersey, Vereinigte Staaten, 07101
        • University of Medicine and Dentistry of New Jersey
    • New York
      • New York, New York, Vereinigte Staaten, 10029
        • Mount Sinai Medical Center
      • New York, New York, Vereinigte Staaten, 10032
        • Columbia University Hospital
    • North Carolina
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27157
        • Wake Forest University
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45267
        • University of Cincinnati
      • Cleveland, Ohio, Vereinigte Staaten, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Vereinigte Staaten, 44195
        • Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • University of Pittsburgh Medical Center, Presbyterian-Shadyside Hospital
    • Tennessee
      • Tullahoma, Tennessee, Vereinigte Staaten, 37388
        • Tennessee Center for Clinical Trials & Harton Regional Medical Center
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75230
        • Cardiopulmonary Research Science and Technology Institute, Medical City Dallas Hospital
      • Houston, Texas, Vereinigte Staaten, 77030
        • Methodist Hospital
    • Utah
      • Murray, Utah, Vereinigte Staaten, 84157
        • Intermountain Medical Center
    • Wisconsin
      • Madison, Wisconsin, Vereinigte Staaten, 53792
        • University of Wisconsin

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Chronic ischemic or non-ischemic cardiomyopathy. Subjects with ischemic cardiomyopathy must have at least one major coronary vessel with Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow.
  • Left ventricular ejection fraction (LVEF) ≤35%
  • Diagnosis of New York Heart Association (NYHA) Class III/IV heart failure for a minimum of 3 months prior to screening
  • Maximal oxygen consumption (VO2 max) ≤20 mL/kg/min within 90 days prior to enrollment
  • An implantable cardioverter defibrillator (ICD) implanted a minimum of 30 days prior to enrollment
  • Treatment with appropriate heart failure therapy as tolerated
  • All women of childbearing potential must have a negative urine pregnancy test prior to administration of investigational product and agree to use adequate contraception. Men capable of fathering a child must agree to use barrier contraception or limit activity to post-menopausal, surgically sterilized, or a contraception-practicing partner, for 3 months after administration of investigational product.
  • Ability to sign Informed Consent Form (ICF) and Release of Medical Information Form

Exclusion Criteria:

  • Any intravenous therapy with positive inotropes, vasodilators, or diuretics within 30 days prior to enrollment
  • Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic LV aneurysm
  • Cardiac surgery, percutaneous coronary intervention, or valvuloplasty within 30 days prior to enrollment
  • Clinically significant myocardial infarction (e.g., ST elevation MI [STEMI] or large non-STEMI) within 6 months prior to enrollment
  • Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), surgically implanted LVAD or cardiac shunt
  • Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, heart transplant, conventional revascularization procedure, or valvular repair within 6 months following enrollment
  • Patients with prior coronary artery bypass graft(s) (CABG) will reviewed on a case-by-case basis
  • No evidence of functional or viable myocardium
  • Exercise capacity primarily limited by obesity, peripheral vascular disease, intrinsic pulmonary disease or orthopedic problems and not by underlying heart failure
  • Known hypersensitivity to octafluoropropane (component of the intravenous echocardiography contrast agent, DEFINITY®) or other contrast dyes used for angiography; history of, or likely need for, high dose steroid pretreatment prior to contrast angiography
  • A left ventricle that is difficult to image or high quality echocardiography is not obtainable at screening
  • Significant left main or ostial right coronary lumenal stenosis in the opinion of the investigator
  • Expected survival <1 year in the investigator's medical opinion
  • Suspected or active viral, bacterial, fungal, or parasitic infection within 48 hours prior to enrollment
  • Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase) >2x Upper Limit of Normal (ULN) within 30 days prior to enrollment or known intrinsic liver disease (e.g., cirrhosis, chronic hepatitis B or hepatitis C virus infection)
  • Current or likely need for hemodialysis within 12 months following enrollment
  • Bleeding diathesis or thrombocytopenia defined as platelet count <50,000 platelets/μL
  • Anemia defined as hemoglobin <10 g/dL
  • Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an absolute neutrophil count <1000 cells/mm3
  • Previous participation in a study of gene transfer
  • Presence of neutralizing anti-AAV1 antibodies at titer ≥1:2 within 3 months of screening
  • Receiving investigational intervention or participating in another clinical study within 30 days or within 5 half-lives of the investigational drug administration prior to enrollment
  • Pregnancy or lactation
  • Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair subject's ability to comply with protocol-mandated procedures, in the opinion of the investigator
  • Other concurrent medical condition(s) that, while not explicitly excluded by the protocol, could jeopardize the safety of the patient or objectives of the study

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: MYDICAR Very Low Dose
Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4x10e11 DNAase resistant particles administered by antegrade epicardial coronary artery infusion. Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) only.
Genetisch: MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)
MYDICAR administered by antegrade epicardial coronary artery infusion
Andere Namen:
  • AAV1/SERCA2a
Experimental: MYDICAR Low Dose
Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6x10e11 DNAase resistant particles administered by antegrade epicardial coronary artery infusion. Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) and MYDICAR Phase 2 (Placebo-controlled, Randomized Study)
Genetisch: MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)
MYDICAR administered by antegrade epicardial coronary artery infusion
Andere Namen:
  • AAV1/SERCA2a
Genetisch: MYDICAR Phase 2 (Placebo-controlled, Randomized Study)
MYDICAR administered by antegrade epicardial coronary artery infusion
Andere Namen:
  • AAV1/SERCA2a
Experimental: MYDICAR Mid Dose
Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3x10e12 DNAase resistant particles administered by antegrade epicardial coronary artery infusion. Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) and MYDICAR Phase 2 (Placebo-controlled, Randomized Study).
Genetisch: MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)
MYDICAR administered by antegrade epicardial coronary artery infusion
Andere Namen:
  • AAV1/SERCA2a
Genetisch: MYDICAR Phase 2 (Placebo-controlled, Randomized Study)
MYDICAR administered by antegrade epicardial coronary artery infusion
Andere Namen:
  • AAV1/SERCA2a
Experimental: MYDICAR High Dose
Single dose of MYDICAR, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1x10e13 DNAase resistant particles administered by antegrade epicardial coronary artery infusion. Used in MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study) and MYDICAR Phase 2 (Placebo-controlled, Randomized Study).
Genetisch: MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)
MYDICAR administered by antegrade epicardial coronary artery infusion
Andere Namen:
  • AAV1/SERCA2a
Genetisch: MYDICAR Phase 2 (Placebo-controlled, Randomized Study)
MYDICAR administered by antegrade epicardial coronary artery infusion
Andere Namen:
  • AAV1/SERCA2a
Placebo-Komparator: Placebo infusion
A single dose of placebo (Sodium Chloride Injection, USP) administered by antegrade epicardial coronary artery infusion.
Verfahren: Placebo Infusion
Saline; epicardial coronary artery infusion

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months
Zeitfenster: 12 months
Includes all adverse events that occurred from the time of first infusion of the investigational product or placebo to the 12-month visit. The category of "TEAEs related to the investigational product (IP)" includes TEAEs considered by the investigator to be possibly, probably, or definitely related to the IP.
12 months
Phase 2: Length of Cardiovascular-related Hospitalizations at 6 Months
Zeitfenster: 6 months
Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.
6 months
Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score
Zeitfenster: Baseline to 6 months

NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).

The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.

For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms.
Baseline to 6 months
Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 6
Zeitfenster: Baseline to 6 months
The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.
Baseline to 6 months
Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 6
Zeitfenster: Baseline to 6 months
Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.
Baseline to 6 months
Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 6
Zeitfenster: Baseline to 6 months
NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.
Baseline to 6 months
Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 6
Zeitfenster: Baseline to 6 months
Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.
Baseline to 6 months
Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) Frm Baseline to Month 6
Zeitfenster: Baseline to 6 months
Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.
Baseline to 6 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Phase 2: Length of Cardiovascular-related Hospitalizations at 12 Months
Zeitfenster: 12 months
Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.
12 months
Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score
Zeitfenster: Baseline to 12 months

NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).

The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.

For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms.
Baseline to 12 months
Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 12
Zeitfenster: Baseline to 12 months
The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.
Baseline to 12 months
Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 12
Zeitfenster: Baseline to 12 months
Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.
Baseline to 12 months
Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 12
Zeitfenster: Baseline to 12 months
NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.
Baseline to 12 months
Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 12
Zeitfenster: Baseline to 12 months
Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.
Baseline to 12 months
Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) From Baseline to Month 12
Zeitfenster: Baseline to 12 months
Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.
Baseline to 12 months
Phase 1 and Phase 2: All Subject Deaths Through 36 Months
Zeitfenster: 36 months
All subject deaths that occurred during the 12-month study or the 24-month follow-up in subjects enrolled in either the Phase 1 or Phase 2 trial. Events occurring after early termination from the trial are listed as occurring during long-term follow-up, but may have been within 12 months. Specifically, two cardiovascular (CV) deaths in placebo subjects occurred following early study termination, but within 12 months of study initiation. These deaths are therefore included under "Deaths within 12 months" but also listed as "Cardiovascular deaths in long-term follow-up." Accordingly, the number of "Cardiovascular deaths in long-term follow-up" for the placebo group is greater than the number of "Deaths after 12 months," as 2 of the deaths occurred within 12 months but after early termination.
36 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Celladon Corporation

Ermittler

  • Hauptermittler: Randall Starling, MD, The Cleveland Clinic
  • Hauptermittler: Thomas Cappola, MD, ScM, University of Pennsylvania
  • Hauptermittler: Brian Jaski, MD, San Diego Cardiac Center
  • Hauptermittler: Stephen Archer, MD, University of Chicago
  • Hauptermittler: Donna Mancini, MD, Columbia University Hospital
  • Studienstuhl: Mariell Jessup, MD, University of Pennsylvania
  • Hauptermittler: Daniel Pauly, MD, Shands Hospital, University of Florida at Gainesville
  • Hauptermittler: Barry London, MD, University of Pittsburgh Medical Center
  • Hauptermittler: Barry Greenberg, MD, University of California at San Diego Medical Center
  • Hauptermittler: A. G. Kfoury, MD, Intermountain Medical Center
  • Hauptermittler: Andrew Kao, MD, Mid America Heart Institute, Saint Luke's Hospital
  • Hauptermittler: Paul J. Hauptman, MD, St. Louis University Hospital
  • Hauptermittler: Jill Kalman, MD, Icahn School of Medicine at Mount Sinai
  • Hauptermittler: Douglas W. Losordo, MD, Northwestern University
  • Hauptermittler: Eric J. Eichhorn, MD, FACC, Cardiopulmonary Research Science and Technology Institutte, Medical City Dallas Hospital
  • Hauptermittler: Stephanie H. Dunlap, DO, University of Cincinnati
  • Hauptermittler: Vinay Thohan, MD, Wake Forest University
  • Hauptermittler: Maryl R. Johnson, MD, University of Wisconsin, Madison
  • Hauptermittler: Mark Dunlap, MD, MetroHealth Medical Center
  • Hauptermittler: Joaquin E. Cigarroa, MD, Oregon Health and Science University
  • Hauptermittler: Dinesh K. Gupta, MD, Tennessee Center for Clinical Trials, Harton Regional Medical Center
  • Hauptermittler: Marc Klapholz, MD, University of Medicine and Dentistry of New Jersey
  • Hauptermittler: Guillermo Torre, MD, The Methodist Hospital Research Institute

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2007

Primärer Abschluss (Tatsächlich)

1. August 2010

Studienabschluss (Tatsächlich)

1. August 2012

Studienanmeldedaten

Zuerst eingereicht

30. März 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. März 2007

Zuerst gepostet (Schätzen)

2. April 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

20. August 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. August 2014

Zuletzt verifiziert

1. August 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CELL-001
  • CUPID Trial (Registrierungskennung: NCT00454818)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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