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Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease

NCT03539952 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-07-02

Study results available
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Summary

This is a multicenter, randomized, open-label study with an active standard-of-care comparator (penicillamine)

Conditions

  • Wilson Disease

Interventions

DRUG

Penicillamine (D1-W12)

Penicillamine during baseline period (D1-W12)

DRUG

TETA 4HCL (W12-60)

TETA 4HCL during post randomisation and 1st extension period (W12-W60)

DRUG

Penicillamine (W12-W60)

Penicillamine during rondomisation and 1st extension period period (W12-W60)

DRUG

TETA 4HCL (60-<W108)

TETA 4HCL during 2nd extension period (W60-\<W108)

Sponsors & Collaborators

  • Orphalan

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2020-08-19
Completion
2022-01-18
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Denmark
  • France
  • Germany
  • Italy
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03539952 on ClinicalTrials.gov