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Undersøgelse til vurdering af sikkerheden og effekten af Larsucosterol hos deltagere med alkoholassocieret hepatitis (AH)

14. oktober 2026 opdateret af: Bausch Health Americas, Inc.

RE-AHFIRM (RandomizEret Undersøgelse af Larsucosterol i Alkoholforbundet Hepatitis til Bekræftelse af Sikkerhed og effektivitet af Behandling)

The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

350

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Rekruttering
        • University of Alabama at Birmingham (UAB) Hospital
      • Mobile, Alabama, Forenede Stater, 36608-3271
        • Ikke rekrutterer endnu
        • University of South Alabama
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85054
        • Rekruttering
        • Mayo Clinic - Phoenix
      • Phoenix, Arizona, Forenede Stater, 85006
        • Rekruttering
        • Banner - University Medical Center, Phoenix, Arizona
    • California
      • Coronado, California, Forenede Stater, 92118
        • Trukket tilbage
        • Southern California GI & Liver Centers - Coronado
      • Fresno, California, Forenede Stater, 93730
        • Ikke rekrutterer endnu
        • Fresno Clinical Research Center (FCRC)
      • La Jolla, California, Forenede Stater, 92037
        • Ikke rekrutterer endnu
        • Scripps
      • La Jolla, California, Forenede Stater, 92093
        • Ikke rekrutterer endnu
        • UC San Diego School of Medicine
      • Los Angeles, California, Forenede Stater, 90048
        • Rekruttering
        • Cedars Sinai Medical Center
      • Los Angeles, California, Forenede Stater, 90095
        • Ikke rekrutterer endnu
        • UCLA Health - Ronald Reagan Medical Center
      • Palo Alto, California, Forenede Stater, 94109
        • Rekruttering
        • Sutter Health
      • Redwood City, California, Forenede Stater, 94063
        • Ikke rekrutterer endnu
        • Stanford Medicine - Clinical and Translational Research Unit - Redwood City
      • Sacramento, California, Forenede Stater, 95816
        • Rekruttering
        • University of California at Davis Medical Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Ikke rekrutterer endnu
        • Yale School of Medicine
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20007
        • Ikke rekrutterer endnu
        • Georgetown University Medical Center
    • Florida
      • Gainesville, Florida, Forenede Stater, 32608
        • Ikke rekrutterer endnu
        • University of Florida (UF)
      • Jacksonville, Florida, Forenede Stater, 32202
        • Rekruttering
        • Mayo Clinic
      • Miami, Florida, Forenede Stater, 33136
        • Ikke rekrutterer endnu
        • University of Miami
      • Miami, Florida, Forenede Stater, 33165
        • Ikke rekrutterer endnu
        • Reliant Medical Research
      • Orlando, Florida, Forenede Stater, 32804
        • Ikke rekrutterer endnu
        • AdventHealth Transplant Institute
      • Tampa, Florida, Forenede Stater, 33606
        • Rekruttering
        • Tampa General Hospital
      • Tampa, Florida, Forenede Stater, 33613
        • Ikke rekrutterer endnu
        • AdventHealth Medical Campus
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Ikke rekrutterer endnu
        • Emory University Hospital
      • Atlanta, Georgia, Forenede Stater, 30309
        • Rekruttering
        • Piedmont Atlanta Hospital - Piedmont Transplant Institute
      • Augusta, Georgia, Forenede Stater, 30912
        • Ikke rekrutterer endnu
        • Augusta University
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rekruttering
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60601
        • Ikke rekrutterer endnu
        • Northwestern University - Feinberg School of Medicine
      • Maywood, Illinois, Forenede Stater, 60153
        • Ikke rekrutterer endnu
        • Loyola University Medical Center (LUMC)
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Ikke rekrutterer endnu
        • Indiana Institute for Medical Research (Indiana VA)
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Rekruttering
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40507
        • Ikke rekrutterer endnu
        • University of Kentucky -Chandler Medical Center
      • Louisville, Kentucky, Forenede Stater, 40206
        • Ikke rekrutterer endnu
        • Robley Rex VA Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Rekruttering
        • Tulane University Health Sciences Center - Tulane Avenue
    • Maine
      • Portland, Maine, Forenede Stater, 04102-3134
        • Ikke rekrutterer endnu
        • Maine Medical Center - Bramhall Campus
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Ikke rekrutterer endnu
        • Johns Hopkins Hospital
      • Baltimore, Maryland, Forenede Stater, 21202
        • Rekruttering
        • Mercy Medical Center - The Institute for Digestive Health and Liver Disease
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forenede Stater, 02118
        • Rekruttering
        • Boston University School of Medicine
      • Boston, Massachusetts, Forenede Stater, 02215
        • Ikke rekrutterer endnu
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02111
        • Ikke rekrutterer endnu
        • Tufts Medical Center
      • Worcester, Massachusetts, Forenede Stater, 01655
        • Rekruttering
        • UMass Chan Medical School
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Rekruttering
        • University of Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Rekruttering
        • Henry Ford Hospital System
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55414-2924
        • Ikke rekrutterer endnu
        • University of Minnesota Medical Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Ikke rekrutterer endnu
        • Saint Luke's Hospital of Kansas City
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89154-9900
        • Ikke rekrutterer endnu
        • University of Nevada Las Vegas
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Ikke rekrutterer endnu
        • Virtua Medical Group (VMG) - Virtua Center for Liver Disease - Toms River
      • Newark, New Jersey, Forenede Stater, 07103-2425
        • Rekruttering
        • Rutgers University New Jersey Medical School
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106-4713
        • Rekruttering
        • University of New Mexico (UNM) Hospital
    • New York
      • Manhasset, New York, Forenede Stater, 11030
        • Rekruttering
        • Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases
      • New York, New York, Forenede Stater, 10016
        • Rekruttering
        • NYU Langone Health
      • New York, New York, Forenede Stater, 10065
        • Ikke rekrutterer endnu
        • NewYork-Presbyterian/Weill Cornell Medical Center
      • New York, New York, Forenede Stater, 10007
        • Ikke rekrutterer endnu
        • Columbia University Medical Center (CUMC) - Presbyterian Hospital and Vanderbilt Clinic
      • Rochester, New York, Forenede Stater, 14642
        • Ikke rekrutterer endnu
        • University of Rochester Medical Center
      • The Bronx, New York, Forenede Stater, 10467
        • Rekruttering
        • Montefiore Medical Center
      • Valhalla, New York, Forenede Stater, 10595
        • Ikke rekrutterer endnu
        • Westchester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • Ikke rekrutterer endnu
        • University of North Carolina (UNC Hospitals)
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Rekruttering
        • Levine Cancer Institute / Atrium Health
      • Durham, North Carolina, Forenede Stater, 27710
        • Ikke rekrutterer endnu
        • Duke University Hospital
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Ikke rekrutterer endnu
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, Forenede Stater, 44114
        • Ikke rekrutterer endnu
        • Cleveland Clinic
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • The Ohio State University Wexner Medical Center (OSUWMC)
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Ikke rekrutterer endnu
        • Oregon Health & Science University
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Rekruttering
        • Penn State Health, Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Ikke rekrutterer endnu
        • Temple University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Rekruttering
        • University of Pennsylvania Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Ikke rekrutterer endnu
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-4551
        • Rekruttering
        • VA Medical Center - Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19141
        • Ikke rekrutterer endnu
        • Einstein Medical Center Philadelphia
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213-3232
        • Ikke rekrutterer endnu
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Rekruttering
        • Medical University of South Carolina
      • Charleston, South Carolina, Forenede Stater, 29401
        • Ikke rekrutterer endnu
        • Ralph H. Johnson Department of Veterans Affairs Medical Center
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37402
        • Ikke rekrutterer endnu
        • Galen Medical Group - Galen Hepatology
      • Nashville, Tennessee, Forenede Stater, 37232
        • Ikke rekrutterer endnu
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75203
        • Rekruttering
        • The Liver Institute at Methodist Dallas Medical Center
      • Dallas, Texas, Forenede Stater, 75246
        • Ikke rekrutterer endnu
        • Baylor Scott White Research Institute - Dallas
      • Denton, Texas, Forenede Stater, 75149-7418
        • Ikke rekrutterer endnu
        • North Texas Gastroenterology
      • Fort Worth, Texas, Forenede Stater, 76104
        • Ikke rekrutterer endnu
        • Baylor Scott & White All Saints Medical Center - Fort Worth
      • Houston, Texas, Forenede Stater, 77074
        • Rekruttering
        • Clinical Trial Network - Houston
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • Baylor College of Medicine (BCM) - Baylor Clinic
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • Methodist Healthcare - Methodist Hospital Specialty and Transplant
      • Temple, Texas, Forenede Stater, 76508
        • Ikke rekrutterer endnu
        • Baylor Scott White Research Institute - Temple
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Rekruttering
        • Intermountain Transplant Clinic
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Ikke rekrutterer endnu
        • University of Utah Health - University of Utah
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Rekruttering
        • University of Virginia Health
      • Richmond, Virginia, Forenede Stater, 23226
        • Rekruttering
        • Bon Secours Liver Institute of Richmond
      • Richmond, Virginia, Forenede Stater, 23249
        • Rekruttering
        • Richmond VA Medical Center
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Ikke rekrutterer endnu
        • Swedish Medical Center
      • Seattle, Washington, Forenede Stater, 98101
        • Ikke rekrutterer endnu
        • Virginia Mason Medical Center (VMMC) - Seattle
      • Seattle, Washington, Forenede Stater, 98104
        • Ikke rekrutterer endnu
        • UW Medicine-Harborview Medical Center
    • West Virginia
      • Huntington, West Virginia, Forenede Stater, 25701
        • Ikke rekrutterer endnu
        • Marshall Health
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53703
        • Ikke rekrutterer endnu
        • University of Wisconsin-Madison

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria-

A participant will be eligible for inclusion in this study if he/she meets all the following criteria:

  1. Able to provide written informed consent (either from participant or participant's legally acceptable representative).

  2. Onset of jaundice within 8 weeks before hospital admission.

  3. Average daily consumption of greater than (>) 40 (females) or >60 (males) grams alcohol for 6 months or longer, with less than (<) 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made and documented by the site Investigator.

  4. The determination of AH will be based on typical serum chemistry (as determined by local laboratory):

    1. Serum total bilirubin >3.0 milligrams per deciliter (mg/dL) (required at randomization)
    2. ALT <400 international unit per Liter (IU/L) (required at randomization)
    3. 50 <AST <400 IU/L
    4. AST <400 IU/L (required at randomization)
    5. AST >50 IU/L (at any time since current hospital admission or leading to this current hospitalization)
    6. AST/ALT >1.5 (at any time since current hospital admission or leading to this current hospitalization)

  5. Maddrey discriminant function (MDF) >=32, assuming a control prothrombin time of 12 seconds.

    NOTE: If a local laboratory's control time differs from 12 seconds, then the local laboratory's control time should be used. If control time is not stated or is stated as a range, the control time should be calculated by the formula prothrombin time/INR.

  6. Original Model for End-stage Liver Disease (MELD; not MELD-Na) score: 21-30 (inclusive).

  7. Male or female participants 18 years of age or older.

  8. Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the 90-day portion of the study. Acceptable methods that may be used are abstinence, birth control pills ("The Pill") or patch, diaphragm, IUD (coil), vaginal ring, condom, surgical sterilization or progestin implant or injection, or sexual activity limited to a sterile (e.g., vasectomized) male partner.

  9. Male participants must agree to use a medically acceptable method of contraception/birth control and refrain from sperm donation throughout the 90-day portion of the study.

  10. Participants must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.

  11. Participants must be dosed within 9 calendar days (216 hours) of hospital admission inclusive of time spent in other hospital(s)

Exclusion Criteria-

A participant will be excluded from the study if he or she meets any of the following criteria:

  1. Participants using systemic corticosteroids for current AH before enrollment or having a history of using systemic corticosteroids for more than 8 days in the last 30 days prior to screening.

    NOTE: Inhaled, topical, or local corticosteroid injections are permitted NOTE: A participant who has a confirmed diagnosis of hypoadrenalism and is taking a physiological replacement dose of hydrocortisone (or equivalent) is permitted to take part in the trial

  2. Participants experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.

  3. Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], cellulitis, pneumonia, bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).

    1. Participants who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.
    2. Participants with bacterial infections may be enrolled provided they remain in the enrollment window and the infection is adequately treated. For example, participants with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP.
    3. Participants with systemic fungal infection of any kind cannot be considered for this trial.

  4. Serum creatinine >2.5 mg/dL.

  5. Participants undergoing continuous veno-venous hemodialysis (CVVH).

  6. Gastrointestinal bleeding not controlled by local therapy (i.e., band ligation or injection sclerotherapy). Participant who are at high risk of rebleeding or likely in need of TIPS insertion should be excluded.

  7. TIPS insertion or variceal embolization within the last 4 weeks.

  8. Known portal vein occlusion.

  9. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.

  10. Liver biopsy (if carried out) with findings not compatible with AH. NOTE: A post-dose liver biopsy that is not compatible with AH will not be considered a protocol deviation.

  11. Stage >=3 hepatic encephalopathy by West Haven criteria.

  12. Participants with medical conditions that are expected to pose a high risk of short-term (less than or equal to [<=] 90 days) mortality unrelated to alcohol-associated hepatitis, or that may confound assessment of 90-day survival in the Investigator's judgement. Examples include, but are not limited to:

    1. Severe concomitant cardiopulmonary disease (e.g., New York Heart Association [NYHA] Class III or IV heart failure)
    2. Clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia, unmanaged atrial fibrillation, QTc >=500 msec, or high-grade AV block)
    3. Ventilator-dependent respiratory failure, or Global Initiative for Chronic Obstructive Lung Disease [GOLD] Stage III or IV chronic obstructive pulmonary disease [COPD])
    4. End-stage renal disease requiring chronic, ongoing dialysis
    5. Severe uncontrolled endocrine or metabolic disorders
    6. Severe psychiatric illness likely to interfere with study participation
    7. Hypotension/shock as defined by the North American Consortium for the study of End-stage Liver Disease (NACSELD) criteria (i.e., Mean Arterial Pressure [MAP] <60 millimeter of mercury (mmHg), despite adequate fluid resuscitation and cardiac output)

  13. Other concomitant cause(s) of liver disease as a result of:

    1. Autoimmune liver disease
    2. Ischemic hepatitis
    3. Wilson disease or alpha 1 antitrypsin deficiency
    4. Vascular liver disease (e.g., Budd-Chiari)
    5. Drug induced liver disease
    6. Surface antigen positive hepatitis B (HBsAg+). NOTE: Participants with isolated core antibody (anti-HBc) or who are on stable antiviral medication with known viral suppression are not excluded, but appropriate HBV prophylaxis should be considered if steroid dosing >4 weeks is anticipated.
    7. Acute hepatitis A (if test performed per SOC)
    8. Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. NOTE: participants with stable chronic HCV or successfully treated HCV are not excluded
    9. Acute hepatitis E (if test performed per SOC)
    10. Acute cytomegalovirus (CMV) viral hepatitis (if test performed per SOC)

  14. Any known active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).

  15. Existing or intended pregnancy or breast feeding.

  16. Participation in another interventional clinical trial within 30 days of Screening.

  17. History of organ transplantation other than corneal transplant.

  18. Underlying disease that, in the opinion of the site Investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.

  19. Participant listed for liver transplant (LT) prior to study drug administration.

  20. Concern of participant's willingness and ability to be compliant with the schedule of protocol assessments, per the Investigator's judgement.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Larsucosterol 30 mg

Participants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.
Medicin: Larsucosterol

Larsucosterol intravenous infusion.

Andre navne:
  • DUR928
  • DV928
Placebo komparator: Placebo

Participants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.
Medicin: Placebo

Matching-placebo (sterile water for injection) intravenous infusion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Transplantationsfri overlevelse op til dag 90
Tidsramme: Op til dag 90
Op til dag 90

Sekundære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse på dag 90
Tidsramme: Dag 90
Dag 90
Tid til død indtil dag 90
Tidsramme: Indtil dag 90
Indtil dag 90
Antal deltagere med dage i live og uden for hospitalet op til dag 90
Tidsramme: Op til dag 90
Op til dag 90
Tid til første indlæggelse af alle årsager efter udskrivelse indtil dag 90
Tidsramme: Op til dag 90
Op til dag 90
Antal deltagere med intensivafdelingsbrug (ICU) op til dag 90
Tidsramme: Op til dag 90
Op til dag 90
Ændring fra baseline i Model for End-Stage Liver Disease (MELD) score
Tidsramme: Dag 7 op til dag 180
Dag 7 op til dag 180
Ændring fra baseline i bilirubinniveauer
Tidsramme: Op til dag 180
Op til dag 180
Overlevelse uden transplantation op til dag 180
Tidsramme: Op til dag 180
Op til dag 180
Overlevelse efter 180 dage
Tidsramme: Dag 180
Dag 180

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bausch Health Americas, Inc.

Samarbejdspartnere

Durect

Efterforskere

  • Studieleder: Varsha Bhatt, PhD, Bausch Health Americas, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. januar 2026

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

1. februar 2028

Datoer for studieregistrering

Først indsendt

19. februar 2026

Først indsendt, der opfyldte QC-kriterier

19. februar 2026

Først opslået (Faktiske)

23. februar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LCAH3141

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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