רדאר קליני AI
הניסוי הקליני NCT07301216 עבור מחלת וילסון הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים

Off Treatment Urinary Copper Excretion in Wilson Disease, Pilot Study 30 מבוסס סמנים ביולוגיים

מגייס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07301216 הוא מחקר מסוג תצפיתי עבור מחלת וילסון, שנמצא כעת במצב מגייס. המחקר התחיל ב-8 בינואר 2026 ומתוכנן לכלול 30 משתתפים. המחקר מנוהל על ידי אוניברסיטת ייל וצפוי להסתיים ב-30 בספטמבר 2028. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-5 במרץ 2026.
סיכום קצר
This is a prospective study that will determine the optimal timing for 24-hour urinary copper excretion (UCE) measurement after temporary discontinuation of standard therapies in Wilson Disease (WD) patients. The primary objective is to assess whether off-treatment UCE (OT-UCE) correlates with non-ceruloplasmin-bound copper (NCC) levels, aiming to validate OT-UCE as a surrogate marker for systemic copper bioavailabil...הצג עוד
תיאור מפורט
Study procedures will include providing multiple urine samples over a 24-hour period, storing the urine samples, and returning them during the end-of-study visit. Blood samples will be collected to measure copper levels and liver function. An in-person end-of-study visit will be attended.

Participation in this study will involve a brief stoppage of current Wilson Disease treatment.

Participants will perform 24-hour...

הצג עוד
כותרת רשמית

Monitoring of Therapy in Wilson Disease With Off-Treatment Urinary Copper Excretion (OT-UCE): Comparison With Serum Non-Ceruloplasmin Copper (NCC) Assays

מצבים רפואיים
מחלת וילסון
פרסומים
מאמרים מדעיים וניירות מחקר שפורסמו על ניסוי קליני זה:
מזהי מחקר נוספים
מספר NCT
תחילת המחקר (בפועל)
2026-01-08
עדכון אחרון שפורסם
2026-03-05
סיום המחקר (מוערך)
2028-09-30
משתתפים (מתוכנן)
30
סוג המחקר
תצפיתי
סטטוס
מגייס
מילות מפתח
Urine copper excretion
Non-ceruloplasmin bound copper
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
OT-UCE and NCC for Zinc treated WD patients
OT-UCE and NCC will be measured in WD patients on Zinc therapy
לא ישים
OT-UCE and NCC for Trientine treated WD patients
OT-UCE and NCC will be measured in WD patients on trientine therapy
לא ישים
OT-UCE and NCC for Penicillamine treated WD patients
OT-UCE and NCC will be measured in WD patients on Penicillamine therapy
לא ישים
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Mean concentration of OT-UCE for each standard of care WD treatment
Urine samples will be collected daily for 4 days after stopping WD medications. The sequential evaluation of OT-UCE over a maximum of 4 days after treatment withdrawal will allow investigators to define the optimal ranges for UCE and select the best time-point for OT-UCE evaluations for WD patients on the 3 different therapies.
days 1, 2, 3 and 4 post stopping WD meds
Mean NCC concentration for each WD treatment
Measure NCC and assess the correlation between NCC and OT-UCE Urine samples will be collected daily for 4 days after stopping WD medications. The sequential evaluation of NCC over a maximum of 4 days after treatment withdrawal will allow investigators to assess the correlation between NCC and OT-UCE.
days 1, 2, 3 and 4 post stopping WD meds
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Mean OT-UCE Ranges for each WD med
Urine samples will be collected daily for 4 days after stopping WD medications. The sequential evaluation of OT-UCE over a maximum of 4 days after treatment withdrawal will allow investigators to define the optimal ranges for UCE for WD patients on the 3 different therapies.
days 1, 2, 3 and 4 post stopping WD meds
Assess the best timepoints for performance of OT-UCE for each drug
The day (or the minimal number of consecutive days) after treatment interruption at which 24-hour OT-UCE stabilizes (defined as a plateau with less than 10% variability between two consecutive measurements) for each drug (zinc, penicillamine, trientine). This will define the optimal timing of OT-UCE monitoring for each treatment.
days 1, 2, 3 and 4 post stopping WD meds
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
  • Patients with Wilson Disease as defined by Leipzig score ≥4.
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures (serial 24 h urine collections and local collection of samples for NCC, liver function and estimated GFR) and availability for the duration of the study.
  • Treated WD for at least 12 months prior to study entry.
  • Aminotransferase values (ASAT and ALAT) < 2 times the upper limit of normal (ULN).
  • INR < 1.5 or stable INR for those with initial elevated INR for at least six months prior to study entry in the absence of anticoagulation therapy.
  • Renal function defined as eGFR > 30 cc/min.
  • No change of WD therapy during the previous 6 months of study enrollment.

  • Current dual / mixed therapy for WD (i.e. zinc and d-penicillamine or trientine at the same time)

  • Current Pregnancy or lactation. *

  • Recent estrogen-based treatment (in the last month).

  • Cirrhosis with recent hepatic decompensation (within the last 6 months) - new onset of ascites, spontaneous bacterial peritonitis, esophageal variceal bleeding, or hepatic encephalopathy

  • Investigator believes the patient will be unable to do the required 24-hour urine studies and participate in the follow up visits as expected.

  • Previous non-compliance for therapy and/or to low-copper diet that would compromise the evaluation of previous UCE and/ or results from the off-treatment period.

    • Childbearing aged patients recruited outside of the registry will be reviewed, and the patients will be asked to perform an initial urine pregnancy test prior to the recommended blood testing (approximately 60 to 90 days prior to intervention). They will be permitted to continue with the screening process if the result is negative. They will be asked to perform a second urine pregnancy test as close as possible prior to study intervention (discontinuation of treatment). If the result of the second pregnancy test is negative they will be permitted to continue with the protocol, but if the result is positive they will be excluded from further participation at that time.

Childbearing aged patients recruited from the registry who meet inclusion criteria and may move directly to the study intervention will be required to perform a urine pregnancy test as close as possible to the time prior to the initiation of the study protocol (discontinuation of treatment).

Yale University logoאוניברסיטת ייל
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) logoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
איש קשר מרכזי למחקר
איש קשר: Sefa Keserci, MD, 203 737 2702, [email protected]
איש קשר: Hatice Maras, MD, [email protected]
1 מיקומי המחקר ב-1 מדינות

Connecticut

Yale School of Medicine, New Haven, Connecticut, 06520, United States
מגייס