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Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture

10 czerwca 2026 zaktualizowane przez: CONNEXT

A Phase 1/2, Multicenter, Dose Escalating, Dose Expanding, Adaptive Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of Collagenase CNT201 in Adult Participants With Dupuytren's Contracture

This trial is a multicenter, Phase 1/2, study to assess the safety, tolerability, efficacy, PK, and immunogenicity of CNT201 in adult participants with DC (Dupuytren's Contracture).

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is an adaptive clinical study design containing 2 steps:

  • Step 1 (dose escalation) is an open-label, dose escalating design where each participant will be enrolled into 1 of 4 dose levels and receive a single administration of CNT201. A Safety Review Committee (SRC) will decide on the dose escalation steps and which dose(s) will be selected to progress into Step 2 dose expansion stage.
  • Step 2 (dose expansion) adopts a randomized, double-blind, placebo-controlled study design. Eligible participants will be randomized to receive either CNT201 or a placebo for up to a total of 3 treatment cycles per cord at the discretion of the Investigator.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Australia
    • Queensland
      • Kippa-Ring, Queensland, Australia, 4021
        • Rekrutacyjny
        • A R Houston Medical Pty Ltd.
        • Kontakt:
          • Anthony R Houston, MD
        • Główny śledczy:
          • Anthony R Houston, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Men and women, 18 to 75 years of age, inclusive.
  • Participants with a diagnosis of DC, with a fixed flexion deformity of at least 1 finger, other than the thumb, that have a contracture at least 20°, but not greater than 100°, for MP (not greater than 80° for PIP) joints, caused by a palpable cord.
  • Participants who have a positive Table Top Test, defined as the inability to simultaneously place the affected finger(s) and palm flat against a tabletop.
  • Participants who are naive to CNT201 treatment.
  • Participants who are judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile.
  • Participants who are willing to voluntarily sign and date the Informed Consent Form (ICF) approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).

Exclusion Criteria:

  • Participants previously exposed to collagenase Clostridium histolyticum for treatment of Dupuytren's disease (Xiaflex, Xiapex®).
  • Participants who have received other treatments for advanced Dupuytren's disease, including surgery (fasciectomy or fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study treatment.
  • Participants with a chronic muscular, neurological, or neuromuscular disorder that affects the hands, or other medical condition which in the Investigator's opinion will make the participant unsuitable for enrollment in the study.
  • Participants who have a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition (eg, testing positive for tuberculosis [TB] or Coronavirus disease 2019 [COVID-19], etc), or history of alcoholism or drug abuse, which in the Investigator's opinion, would make the participant unsuitable for enrollment in the study.
  • Participants who have a known allergic response to collagenase or any other excipient of CNT201 or Xiaflex.
  • Participants who have received a doxycycline or tetracycline derivative within 14 days before the beginning of the study (tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs).
  • Participants who have received an anticoagulant (except aspirin ≤150 mg/day) within 7 days before the start of the study.
  • Female participants who are nursing or pregnant, or plan to become pregnant during the study treatment stage of the study.
  • Participants who have been treated with any investigational drug within 30 days of first dose of study treatment.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: [Step1] CNT201 First-dose
Lek: [Step1] CNT201 First-dose

CNT201: recombinant collagenase

• Unit Dose Strength(s)/ Dosage Level(s): First-dose
Eksperymentalny: [Step1] CNT201 Low-dose
Lek: [Step1] CNT201 Low-dose

CNT201: recombinant collagenase

• Unit Dose Strength(s)/ Dosage Level(s): Low-dose
Eksperymentalny: [Step1] CNT201 Intermediate-dose
Lek: [Step1] CNT201 Intermediate-dose

CNT201: recombinant collagenase

• Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose
Eksperymentalny: [Step1] CNT201 High-dose
Lek: [Step1] CNT201 High-dose

CNT201: recombinant collagenase

• Unit Dose Strength(s)/ Dosage Level(s): High-dose
Eksperymentalny: [Step2] CNT201
Lek: [Step2] CNT201
eligible participants will be randomized to 1 of 2 or more treatment arms, depending on the number of CNT201 doses selected for administration in Step 2
Komparator placebo: [Step2] Placebo
Lek: [Step2] Placebo
• Saline

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
[Step 1] Incidence of adverse events
Ramy czasowe: Day 1 through Day 57
Adverse events including TEAEs, SAEs, and AESIs assessed by frequency and severity, coded using MedDRA and graded per CTCAE v5.0. All adverse event types will be aggregated and reported as overall incidence of adverse events.
Day 1 through Day 57
[Step 1] Change from baseline in systolic and diastolic blood pressure
Ramy czasowe: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
[Step 1] Change from baseline in pulse rate
Ramy czasowe: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
[Step 1] Change from baseline in respiratory rate
Ramy czasowe: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
[Step 1] Change from baseline in body temperature
Ramy czasowe: Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
Screening, Day 1 (pre-dose and post-dose up to 6 hours), Day 2, 3, 8, 15, 29, and Day 57
[Step 1] Change from baseline in 12-lead ECG parameters
Ramy czasowe: Screening and Day 1 (1 hour post-dose)
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
Screening and Day 1 (1 hour post-dose)
[Step 1] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
Ramy czasowe: Screening and Day 57
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters. The number of participants with clinically significant changes from baseline will be summarized.
Screening and Day 57
[Step 1] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Ramy czasowe: Screening, Day 1 (pre-dose), Day29, and Day 57
Complete physical examinations were performed at scheduled visits. Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
Screening, Day 1 (pre-dose), Day29, and Day 57
[Step 1] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension
Ramy czasowe: Within 29 days of study treatment injection
Finger joint contracture (MP and PIP joints) measured by goniometry.
Within 29 days of study treatment injection
[Step 2] Incidence of TEAEs, SAEs, and AESIs by severity
Ramy czasowe: Screening through Month 12
Frequency and severity of adverse events coded using MedDRA and graded per CTCAE v5.0.
Screening through Month 12
[Step 2] Change from baseline in systolic and diastolic blood pressure
Ramy czasowe: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
Systolic and diastolic blood pressure will be measured in mmHg, and the change from baseline will be evaluated at each scheduled visit.
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
[Step 2] Change from baseline in pulse rate
Ramy czasowe: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
Pulse rate will be measured in beats per minute (bpm), and the change from baseline will be assessed at each scheduled visit.
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
[Step 2] ] Change from baseline in respiratory rate
Ramy czasowe: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
Respiratory rate will be measured in breaths per minute, and the change from baseline will be evaluated at each scheduled visit.
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
[Step 2] Change from baseline in body temperature
Ramy czasowe: Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
Body temperature will be measured in degrees Celsius (°C), and the change from baseline will be evaluated at each scheduled visit.
Screening, Day 1 of each injection cycle (pre-dose and post-dose up to 48 hours), Day 3, 8, 29 of each cycle, and Month 12 (each cycle is 28 days)
[Step 2] Change from Baseline in Electrocardiogram Parameters
Ramy czasowe: Screening and Day 1 (1 hour post-dose) of each cycle (each cycle is 28 days)
Electrocardiogram (ECG) parameters including heart rate, PR interval, QRS duration, QT interval, and corrected QT interval using Fridericia's formula (QTcF) will be assessed using automated 12-lead ECG recordings.
Screening and Day 1 (1 hour post-dose) of each cycle (each cycle is 28 days)
[Step 2] Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Ramy czasowe: Screening, Day 1 of each injection cycle (pre-dose), Day 29 of each cycle and Month 12 (each cycle is 28 days)
Complete physical examinations were performed at scheduled visits. Clinically significant abnormalities, including injection site reactions, were recorded and summarized as the number of participants with abnormalities.
Screening, Day 1 of each injection cycle (pre-dose), Day 29 of each cycle and Month 12 (each cycle is 28 days)
[Step 2] Number of Participants with Clinically Significant Changes in Clinical Laboratory Test Results
Ramy czasowe: Screening through Week 52
Clinical laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis parameters. The number of participants with clinically significant changes from baseline will be summarized.
Screening through Week 52
[Step 2] Proportion of participants achieving reduction in contracture to within 0-5° of normal extension within 29 days after the first injection
Ramy czasowe: Within 29 days after first injection
Finger joint contracture (MP and PIP joints) measured by goniometry.
Within 29 days after first injection

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
[Step 1] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Ramy czasowe: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
Assessed by finger goniometry at each scheduled visit.
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Mean percent change in degree of contracture
Ramy czasowe: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
Assessed by finger goniometry (MP and PIP joints).
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Time to clinical success (contracture ≤5°)
Ramy czasowe: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
Defined as the first study day on which treated joint contracture is ≤5°.
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Change in range of motion (full extension, full flexion, and total arc)
Ramy czasowe: Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
Assessed by finger goniometry (MP and PIP joints).
Screening, Day 1 (pre-dose and 6 hours post-dose), Day 3, 8, 15, 29, and Day 57
[Step 1] Participant Global Assessment of Treatment Satisfaction Score
Ramy czasowe: Screening, Day 29, and Day 57
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied). Lower scores indicate greater satisfaction.
Screening, Day 29, and Day 57
[Step 1] Physician Global Assessment of Disease Severity Score
Ramy czasowe: Screening, Day 29, and Day 57
Disease/contracture severity will be assessed by the investigator using a study-specific 4-point scale (1 = Normal, 2 = Mild, 3 = Moderate, 4 = Severe). Higher scores indicate greater severity.
Screening, Day 29, and Day 57
[Step 1] Physician Global Assessment of Treatment Satisfaction Score
Ramy czasowe: Screening, Day 29, and Day 57
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied). Lower scores indicate greater satisfaction.
Screening, Day 29, and Day 57
[Step 1] Peak plasma concentration (Cmax) of CNXT1 and CNXT2
Ramy czasowe: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Time to peak plasma concentration (tmax) of CNXT1 and CNXT2
Ramy czasowe: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Area under the plasma concentration-time curve (AUC) of CNXT1 and CNXT2
Ramy czasowe: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Half-life (t½) of CNXT1 and CNXT2
Ramy czasowe: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Clearance (CL) of CNXT1 and CNXT2
Ramy czasowe: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Volume of distribution (Vd/F) of CNXT1 and CNXT2
Ramy czasowe: Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
Assessed from plasma concentrations of CNXT1 and CNXT2 collected at scheduled timepoints.
Day 1 (pre-dose through 48 hours post-dose), Day 3, 4, 5, 6, 7
[Step 1] Incidence of anti-drug antibodies against CNXT1 and CNXT2
Ramy czasowe: Day 1 (pre-dose), Day 15, 29, and Day 57
Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.
Day 1 (pre-dose), Day 15, 29, and Day 57
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension at Day 85 after first injection
Ramy czasowe: Day 85 after first injection
Assessed by finger goniometry.
Day 85 after first injection
[Step 2] Proportion of participants achieving contracture ≤5° of normal extension within 29 days after the last injection
Ramy czasowe: Within 29 days after last injection
Assessed by finger goniometry.
Within 29 days after last injection
[Step 2] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Ramy czasowe: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
Assessed by finger goniometry at each scheduled visit.
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Mean percent change in degree of contracture
Ramy czasowe: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
Assessed by finger goniometry (MP and PIP joints).
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Time to clinical success (contracture ≤5°)
Ramy czasowe: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
Defined as the first study day on which treated joint contracture is ≤5°.
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Change in range of motion (full extension, full flexion, and total arc)
Ramy czasowe: Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
Assessed by finger goniometry (MP and PIP joints).
Screening, Day 1 of each injection cycle (pre-dose), Day 3, 8, 29 of each cycle, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
[Step 2] Participant Global Assessment of Treatment Satisfaction Score
Ramy czasowe: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied). Lower scores indicate greater satisfaction.
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Physician Global Assessment of Disease Severity Score
Ramy czasowe: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
Disease/contracture severity will be assessed by the investigator using a study-specific 4-point scale (1 = Normal, 2 = Mild, 3 = Moderate, 4 = Severe). Higher scores indicate greater severity.
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Physician Global Assessment of Treatment Satisfaction Score
Ramy czasowe: Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
Treatment satisfaction will be assessed by the investigator using a study-specific 5-point Likert scale (1 = Very satisfied, 2 = Satisfied, 3 = Neither satisfied nor dissatisfied, 4 = Dissatisfied, 5 = Very dissatisfied). Lower scores indicate greater satisfaction.
Screening, Day 29 of each injection cycle, and Month 12 (each cycle is 28 days)
[Step 2] Time to recurrence
Ramy czasowe: Month 2, 3, 4, 6, 9, and Month 12
Defined as an increase in joint contracture to ≥20° in the presence of a palpable cord.
Month 2, 3, 4, 6, 9, and Month 12
[Step 2] Proportion of participants with contracture recurrence at Month 12
Ramy czasowe: Month 12
Recurrence defined as joint contracture ≥20° in the presence of a palpable cord.
Month 12
[Step 2] Incidence of anti-drug antibodies against CNXT1 and CNXT2
Ramy czasowe: Screening, Day 1 of Cycle 1, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)
Antibody incidence, titers, and neutralizing antibodies assessed from blood samples.
Screening, Day 1 of Cycle 1, Month 2, 3, 4, 6, 9, and Month 12 (each cycle is 28 days)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

CONNEXT

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

23 lipca 2024

Zakończenie podstawowe (Szacowany)

1 lipca 2027

Ukończenie studiów (Szacowany)

25 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

23 sierpnia 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

10 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • DC2201

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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