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

PHASE3CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

September 3, 2018

Primary Completion Date

August 19, 2020

Study Completion Date

January 18, 2022

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)

Trial Locations (15)

20142

A.O. San Paolo Milano, Milan

35128

DiSCOG Gastroenterology Unit, Padua

69120

Innere Medizin, Heidelberg

69677

Hospital mother children, Bron

75475

Centre National de Référence Wilson, Hôpital Lariboisière, Paris

81377

Poliklinik Hepatologie/Transplantationsambulanz, Munich

06510

Yale University School of Medicine, New Haven

Unknown

KU Leuven, Department of Clinical and Experimental Medicine, Leuven

Hospital Nossa Senhora das Graças (HNSG), Curitiba

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

Hepato-gastroenterologisk afd, Aarhus

60430-275

Nucleo de Pesquisa e Desenvolvimento de Medicamentos - Universidade Federal do Ceará - Rodolfo Teófilo, Fortaleza

02 957

Institute of Psychiatry and Neurology, Warsaw

GU2 7XH

University of Surrey, Department of Clinical and Experimental Medicine, Guildford

LS9 7TF

Leeds Teaching Hospitals NHS Trust, Leeds

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Orphalan

INDUSTRY