Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
5. června 2026 aktualizováno: 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).
Přehled studie
Postavení
Nábor
Detailní popis
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 studie
Intervenční
Zápis (Odhadovaný)
60
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Suntae Kim
- Telefonní číslo: +82-10-5682-2489
- E-mail: suntae.kim@connext.co.kr
Studijní místa
-
-
Queensland
-
Kippa-Ring, Queensland, Austrálie, 4021
- Nábor
- A R Houston Medical Pty Ltd.
-
Kontakt:
- Anthony R Houston, MD
-
Vrchní vyšetřovatel:
- Anthony R Houston, MD
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: [Step1] CNT201 First-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): 0.1 mg/cord |
|
Experimentální: [Step1] CNT201 Low-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): 0.3 mg/cord |
|
Experimentální: [Step1] CNT201 Intermediate-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): 0.6 mg/cord |
|
Experimentální: [Step1] CNT201 High-dose
|
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): 0.8 mg/cord |
|
Experimentální: [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
|
|
Komparátor placeba: [Step2] Placebo
|
• Saline
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
[Step 1] Incidence of adverse events
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Within 29 days after first injection
|
Finger joint contracture (MP and PIP joints) measured by goniometry.
|
Within 29 days after first injection
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
[Step 1] Proportion of participants achieving clinical improvement (≥50% reduction in contracture from Day 1)
Časové okno: 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
Časové okno: 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°)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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°)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
23. července 2024
Primární dokončení (Odhadovaný)
1. července 2027
Dokončení studie (Odhadovaný)
25. července 2027
Termíny zápisu do studia
První předloženo
23. srpna 2024
První předloženo, které splnilo kritéria kontroly kvality
5. června 2026
První zveřejněno (Aktuální)
10. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
10. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
5. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DC2201
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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