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Postoperativ bruk av FS2 for å dempe arrdannelse hos forbrenningspasienter

29. september 2026 oppdatert av: Birch BioMed Inc

Postoperativ aktuell administrering av fibrose som hemmer forbindelsen FS2 i en dobbeltblind, randomisert, kjøretøykontrollert studie som evaluerer sikkerhet og avbøtning av kutan arrdannelse i hudtransplantasjon og donorsteder hos forbrenningspasienter

The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery. A cream with FS2 will be used on both the area where the skin graft was placed and the area where the skin was taken (donor site). The cream will be applied after the skin has healed. This study will help us understand if FS2 is safe and effective for mitigating skin scar formation in burn patients.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

For the first 90 days of the study, neither the patient nor the investigator will know which cream is being used: either the control cream (IP1) or the treatment cream (IP2), which contains 0.5% FS2. The assigned study product will be applied to the donor site and the skin graft site. After the first 90 days, all patients will use the FS2 cream for another 90 days in an open-label period where everyone knows they are receiving FS2.

The graft and donor sites will be photographed and assessed (POSAS and VSS), scored and recorded at the initial visit and again at every assessment visit thereafter.

An interim analysis will take place when about half of the participants (36 people) have finished their Day 90 visit. Based on the results, the study may continue as planned with the two-treatment, blinded design, or it may switch to an open-label format where all patients (those already in the study or newly enrolled) will use the FS2 cream.

Oversight - Human Subjects Protection Review section continued:

Site #02 (Edmonton) Approval Number: Pro00151882 Board Name: HREB - Biomedical Panel Board Affiliation: HREB - University of Alberta Board Contact Information: 780-492-8320 (Phone), vnadeau@ualberta.ca (Email)

Studietype

Intervensjonell

Registrering (Antatt)

70

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Rekruttering
        • University of Alberta, Division of Plastic Surgery
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alex Morzycki, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Rekruttering
        • Centre for Burn Research - Hamilton Health Sciences
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marc Jeschke, PHD
        • Underetterforsker:
          • Stephanie Chadwick, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 65 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Medically able and willing to consent/assent to study requirements
  2. Male and female burn patients
  3. 12 to 65 years of age (inclusive)
  4. Able to understand the study requirements and consent without a translator. Where applicable, participant's legally authorized representative (LAR) is willing and able to agree to the requirements and restrictions of the study, be willing to give voluntary informed consent (or assent, if capable), be able to understand and read the questionnaires, carry out all study-related procedures, and communicate effectively with the study staff.
  5. Have a BMI between 15 and 35 kg/m2 (inclusive)
  6. Have clinically acceptable results in the safety laboratory tests as deemed by the investigator
  7. Have full thickness burn injury that required partial thickness skin graft (meshed or sheet) for any location other than the face and genitalia
  8. Skin graft size is between 50 cm2 and 800 cm2 (post-meshing, if a meshed graft)
  9. If skin graft is meshed, maximum skin graft expansion ratio is 1:1.5
  10. Able to apply the IPs as instructed, whether by the participants themselves or their accompanying caregivers

Exclusion Criteria:

  1. Medically unable to consent to study requirements
  2. Treatment site(s) (skin graft site) located on the face and genitalia
  3. Treatment site(s) (skin graft site and skin donor site) that has not reached complete re-epithelization at baseline, based on the investigator's assessment
  4. Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
  5. Pregnant, or attempting to become pregnant
  6. Subjects who had taken part in an interventional clinical trial within 3 months prior to admission to this trial or who are currently participating in a clinical trial, whether an investigational drug was used or not
  7. Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness within the last year
  8. Subjects who smoke more than 20 cigarettes a day
  9. Subjects who have a history of heavy drinking in the past month, defined as more than 14 drinks per week for men or more than 7 drinks per week for women
  10. Subjects who have a history of substance abuse within the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention)
  11. Subjects with severe inhalation injury requiring FiO2 >50%, renal failure requiring dialysis or hemodynamic instability requiring vasopressor therapy at the time of initiation of study treatment
  12. Subjects who have scarring from previous interventions or evidence of thermal, electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the treatment sites
  13. Subjects with a history of abnormal keloid scarring
  14. Subjects with additional concurrent illnesses or conditions that may have interfered with wound healing like neoplastic, immune-mediated, or primary infectious disease (e.g. carcinoma, vasculitis, connective tissue disease, immune system disorders, uncontrolled HIV infection, rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled congestive heart failure or diabetes mellitus) or any clinically significant medical condition or history of any condition which may impair wound healing
  15. Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial (including psoriasis, dermatitis, eczema)
  16. A history of radiotherapy to the study scar area
  17. Subjects who have known sensitivity to any components of the IPs
  18. Any other diagnosis, condition, physical or geographical limitation with the participant

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Skin Grafted wound

The wound site (injury)
Legemiddel: IP1 control cream (Vehicle base)

Without FS2

Legemiddel: IP2 - 0.5% w/w FS2

FS2 in pharmaceutical compounding base
Eksperimentell: Donor Skin Graft Harvest wound

A Surgical wound
Legemiddel: IP1 control cream (Vehicle base)

Without FS2

Legemiddel: IP2 - 0.5% w/w FS2

FS2 in pharmaceutical compounding base

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Scar condition of the skin grafted wound on Day 90 as assessed by VSS
Tidsramme: 90 days

To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by Vancouver Scar Scale (VSS) at the skin grafted wound (Study Arm 1)
90 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS
Tidsramme: 90 days

To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at the donor skin graft harvest site (Study Arm 2)
90 days
Scar condition of the skin graft wound on Day 28 and Day 60 as assessed by VSS
Tidsramme: Day 28 and Day 60

To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: skin grafted wound (Study Arm 1)
Day 28 and Day 60
Scar condition of the donor skin graft harvest site on Day 28 and Day 60 as assessed by VSS
Tidsramme: Day 28 and Day 60

To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: donor skin graft harvest site (Study Arm 2)
Day 28 and Day 60
Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS
Tidsramme: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by the Observer component of Patient and Observer Scar Assessment Scale (POSAS) at skin grafted wound (Study Arm 1)
Day 28, Day 60 and Day 90
Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS
Tidsramme: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by (POSAS) at: donor skin graft harvest site (Study Arm 2)
Day 28, Day 60 and Day 90
Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS
Tidsramme: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on patient-reported scar condition at: skin grafted wound (Study Arm 1)
Day 28, Day 60 and Day 90
Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS
Tidsramme: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2)
Day 28, Day 60 and Day 90
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - POSAS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - VSS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - VSS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on patient-reported scar condition at: skin grafted wound (Study Arm 1) -POSAS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - POSAS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - VSS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - VSS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on patient-reported scar condition at: skin grafted wound (Study Arm 1)
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS
Tidsramme: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2)
Day 120 and Day 180
Quality of life on Day 28, Day 60, and Day 90 as assessed by the Burn Specific Health Scale-Brief (BSHS-B)
Tidsramme: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on burn injury-related quality of life
Day 28, Day 60 and Day 90
Quality of life on Day 120 and Day 180 as assessed by BSHS-B
Tidsramme: Day 120 and Day 180

Quality of life on Day 120 and Day 180 as assessed by BSHS-B To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on burn injury-related quality of life in those randomized to control for the first 90 days of study
Day 120 and Day 180
Quality of life on Day 120 and Day 180 as assessed by BSHS-B
Tidsramme: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on burn injury-related quality of life in those randomized to FS2 cream for the first 90 days of study Quality of life on Day 120 and Day 180 as assessed by BSHS-B
Day 120 and Day 180

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
Tidsramme: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)
Day 28, Day 60 and Day 90
Scar height(cm) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
Tidsramme: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)
Day 28, Day 60 and Day 90
Scar size(cm2) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs
Tidsramme: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)
Day 28, Day 60 and Day 90
Scar height(cm) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs
Tidsramme: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)
Day 28, Day 60 and Day 90
Scar size(cm2) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs
Tidsramme: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: skin grafted wound (Study Arm 1)
Day 120 and Day 180
Scar height(cm) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs
Tidsramme: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on wound scarring from: skin grafted wound (Study Arm 1)
Day 120 and Day 180
Scar size(cm2)at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs
Tidsramme: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: donor skin graft harvest site (Study Arm 2)
Day 120 and Day 180
Scar height(cm) at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs
Tidsramme: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on wound scarring from: donor skin graft harvest site (Study Arm 2)
Day 120 and Day 180
To evaluate the Safety of FS2 Cream - Adverse events
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Report of Adverse Events
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Whole Blood Hemoglobin (g/dl)
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Hematocrit (%)
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Red Blood Cell Count
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Red Cell distribution Width
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean corpuscular Volume
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin Concentration
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - White Blood Cell Count and Differential
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Platelet Count
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean Platelet Volume
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - AST
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory parameters: Clinical Chemical Parameters
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - ALT
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters: Clinical chemistry parameters:
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - GGT
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Alkaline Phosphate
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters: Clinical chemistry parameters
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Creatinine
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters Clinical chemistry parameters.
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - BUN
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Bilirubin Total
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters: Clinical chemistry parameters.
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Bilirubin Direct
Tidsramme: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters: Clinical chemistry parameter.
Day 0, Day 28, Day 60, Day 90 and Day 180

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Birch BioMed Inc

Samarbeidspartnere

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Etterforskere

  • Studieleder: Carlos Camozzi, MD, PHD, BirchBioMed Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mars 2027

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

22. januar 2025

Først innsendt som oppfylte QC-kriteriene

31. januar 2025

Først lagt ut (Faktiske)

4. februar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • B04-23-01-T0058

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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