At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 77 enrolled
Drug / intervention
Penicillamine (D1-W12) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
CHELATE STUDY: Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease
In Brief
A Phase 3 clinical trial evaluating Penicillamine (D1-W12), TETA 4HCL (W12-60), and 2 other interventions for Wilson Disease. Completed, enrolled 77 participants across 15 sites in 9 countries.
Detailed Summary
This is a multicenter, randomized, open-label study with an active standard-of-care comparator (penicillamine)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWilson Disease
CountriesBelgium, Brazil, Denmark, France, Germany, Italy, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartSep 2018
Primary CompletionAug 2020
Study CompletionJan 2022
TodayJul 2026
First PostedMay 30, 2018
Enrollment StartSep 3, 2018
Primary CompletionAug 19, 2020
Study CompletionJan 18, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.1 years ago
Interventions
Penicillamine (D1-W12)drug
Penicillamine during baseline period (D1-W12)
TETA 4HCL (W12-60)drug
TETA 4HCL during post randomisation and 1st extension period (W12-W60)
Penicillamine (W12-W60)drug
Penicillamine during rondomisation and 1st extension period period (W12-W60)
TETA 4HCL (60-<W108)drug
TETA 4HCL during 2nd extension period (W60-\<W108)