Search of: "Wilson disease" - List Results

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20 Studies found for: "Wilson disease"

Also searched for Hepatolenticular degeneration. See Search Details

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NCT03334292

Recruiting

Natural History of Wilson Disease

Wilson Disease

Observational

Yale University

Other

Observational Model: Cohort
Time Perspective: Prospective

Create registry for Wilson disease

300

All

Child, Adult, Older Adult

NCT03334292

1609018429

December 18, 2017

November 15, 2022

November 15, 2027

November 7, 2017

January 9, 2018

Yale University
New Haven, Connecticut, United States

NCT01472874

Completed
Has Results

Single Daily Dosage of Trientine for Maintenance Treatment for Wilson Disease

Wilson Disease

Drug: Once a day Trientine

Interventional

Not Applicable

Yale University
Valeant Pharmaceuticals International, Inc.

Other / Industry

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

ALT
Cu Serum
INR
(and 3 more...)

All

18 Years and older (Adult, Older Adult)

NCT01472874

ORPH-SYP-001

January 2010

July 2011

November 17, 2011

May 22, 2014

May 19, 2014

Yale University
New Haven, Connecticut, United States

NCT03299829

Recruiting

A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients

Trientine Treatment for Wilson's Disease

Drug: Trientine

Observational

Excelsior

Industry

Observational Model: Cohort
Time Perspective: Retrospective

The improvement in liver function
The improvement in urine copper excretion

All

3 Years to 75 Years (Child, Adult, Older Adult)

NCT03299829

EB-TR-001

January 10, 2018

August 31, 2018

October 30, 2018

October 3, 2017

March 26, 2018

Chang Gung Memorial Hospital, Linkou
Taoyuan City, Taiwan

NCT03539952

Not yet recruiting
New

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

Wilson Disease

Drug: TETA 4HCL
Drug: Penicillamine

Interventional

Phase 3

GMP-Orphan SAS

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Serum NCC concentration
24-hour urinary copper excretion
Clinical Global Impression of Change (CGIC) rating scale

All

18 Years to 75 Years (Adult, Older Adult)

NCT03539952

GMPO-131-002

May 2018

September 2019

March 2021

May 30, 2018

NCT03403205

Recruiting

Efficacy and Safety of WTX101 Administered for 48 Weeks Versus Standard of Care in Wilson Disease Subjects

Wilson Disease

Drug: WTX101
Drug: SOC Therapy

Interventional

Phase 3

Wilson Therapeutics AB

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Evaluate the efficacy of WTX101 using standard of care as comparator and copper as the control assessed in terms of the percentage change from baseline (Day 1) to 48 weeks in non-ceruloplasmin-bound copper levels
Safety and tolerability of individualized dosing of WTX101 by descriptive statistics via the Safety Analysis Set dataset
Effects of WTX101 on hepatic status
(and 4 more...)

102

All

18 Years and older (Adult, Older Adult)

NCT03403205

WTX101-301

February 15, 2018

December 18, 2019

February 14, 2024

January 18, 2018

June 7, 2018

University of California, Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States
(and 28 more...)

NCT02763215

Active, not recruiting

The Assessment of Copper Parameters in Wilson Disease Subjects on Standard of Care Treatment

Wilson Disease

Observational

Wilson Therapeutics AB

Industry

Observational Model: Cohort
Time Perspective: Prospective

Plasma Copper (Cu) parameter: Total Copper (Cu)
Plasma Copper (Cu) parameter: Total Molybdenum (Mo)
Plasma Copper (Cu) parameter: Speciation profiling
(and 7 more...)

All

18 Years and older (Adult, Older Adult)

NCT02763215

WTX101-203

May 2016

December 2018

May 5, 2016

January 20, 2017

Yale University School of Medicine
New Haven, Connecticut, United States
Northwestern University
Chicago, Illinois, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
(and 7 more...)

NCT02702765

Recruiting

sCD163 and sMR in Wilsons Disease - Associations With Disease Severity and Fibrosis

Wilsons Disease

Procedure: Fibroscan
Procedure: Ultrasound
Drug: Galactose
(and 2 more...)

Interventional

Not Applicable

University of Aarhus
Aarhus University Hospital

Other

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Measurement of the macrophage activation markers sCD163
Measurement of soluble mannose receptor (sMR)
Urinary copper excretion in 24 hour urine collection
(and 7 more...)

All

18 Years to 100 Years (Adult, Older Adult)

NCT02702765

Wilson sCD163

February 2016

February 2020

March 9, 2016

May 2, 2018

Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, Denmark

NCT02273596

Active, not recruiting

Efficacy and Safety Study of WTX101 in Adult Wilson Disease Patients

Wilson Disease

Drug: WTX101

Interventional

Phase 2

Wilson Therapeutics AB

Industry

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Nonceruloplasmin-bound copper (NCC) levels adjusted for molybdenum (Mo) plasma concentration
Change in and time to normalisation of NCC levels adjusted for Mo plasma concentration
Neurological status using the Unified Wilson's Disease Rating Scale (UWDRS)
(and 15 more...)

All

18 Years and older (Adult, Older Adult)

NCT02273596

WTX101-201

November 2014

June 2018

August 2018

October 24, 2014

December 21, 2017

UCLA Medical Center
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Northwestern University
Chicago, Illinois, United States
(and 8 more...)

NCT02426905

Active, not recruiting

Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine

Wilson Disease

Drug: trientine dihydrochloride

Interventional

Phase 4

Univar BV

Industry

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Clinical outcome specific to the retrospective part of the study
Clinical outcome specific to the prospective part of the study
Safety Endpoint Applicable to both the Retrospective and Prospective Parts of the Study
Quality of Life Endpoints for the Prospective Part of the Study

All

1 Year to 90 Years (Child, Adult, Older Adult)

NCT02426905

UNV-TRI-002

January 2016

May 2018

July 2018

April 27, 2015

August 23, 2017

Universitätsklinik Heidelberg
Heidelberg, Germany
"Aghia Sophia" Children's Hospital
Goudi, Greece
San Paolo Hospital UOC
Milan, Italy
Kings College Hospital
London, United Kingdom

NCT01874028

Completed

A Phase 1 Study to Assess the Effects in the Body of a Single Dose of Trientine Dihydrochloride in Wilson's Disease Patients

Wilson's Disease

Drug: trientine dihydrochloride

Interventional

Phase 1

Univar BV
Aptiv Solutions

Industry

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Pharmacokinetic measurements

All

6 Years to 90 Years (Child, Adult, Older Adult)

NCT01874028

TR-001PK

May 2013

March 2014

June 10, 2013

September 19, 2014

Universitätsklinik Heidelberg
Heidelberg, Germany

NCT00212355

Completed
Has Results

Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.

Wilson's Disease

Drug: NPC-02

Interventional

Phase 3

Nobelpharma

Industry

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Safety

All

1 Year and older (Child, Adult, Older Adult)

NCT00212355

NPC-02-2

March 2005

April 2008

January 2009

September 21, 2005

May 14, 2014

NCT00004338

Completed

Study of Zinc for Wilson Disease

Wilson Disease

Drug: zinc acetate

Interventional

Phase 4

National Center for Research Resources (NCRR)
University of Michigan

NIH / Other

Primary Purpose: Treatment

300

All

Child, Adult, Older Adult

NCT00004338

199/11897
UMMC-310

October 1993

October 19, 1999

June 24, 2005

University of Michigan Health Systems
Ann Arbor, Michigan, United States

NCT00004339

Completed

Study of Tetrathiomolybdate in Patients With Wilson Disease

Wilson Disease

Drug: tetrathiomolybdate
Drug: trientine

Interventional

Phase 3

National Center for Research Resources (NCRR)
University of Michigan

NIH / Other

Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

All

Child, Adult, Older Adult

NCT00004339

NCRR-M01RR00042-1850
UMMC-801
UMICH-FDU000505

January 1994

October 19, 1999

May 9, 2006

University of Michigan
Ann Arbor, Michigan, United States

NCT01378182

Completed

Efficacy of Invitro Expanded Bone Marrow Derived Allogeneic Mesenchymal Stem Cell Transplantation Via Portal Vein or Hepatic Artery or Peripheral Vein in Patients With Wilson Cirrhosis

Wilson's Disease

Genetic: allogeneic mesenchymal stem cell transplantation

Interventional

Not Applicable

Murat Kantarcioglu
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Other

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

differantiation of transplanted mesenchymal stem cells to hepatocytes in post treatment liver biopsies

All

18 Years to 65 Years (Adult, Older Adult)

NCT01378182

110S153

April 2011

March 2013

December 2014

June 22, 2011

December 31, 2014

Department of Gastroenterology; Gulhane Military Medical Academy
Ankara, Turkey

NCT02552628

Recruiting

WILSTIM - DBS (WILson STIMulation - Deep Brain Stimulation)

Severe Dystonia
Wilson's Disease

Device: Medtronic, Activa® PC "on"
Device: Medtronic, Activa® PC "off"

Interventional

Not Applicable

Hospices Civils de Lyon

Other

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Change in movement disorder evaluated by the Canadian Occupational Performance Measure (COPM) performance and satisfaction scores
Other movement disorder will be assessed by the reduction of the Burke-Fahn-Marsden (BFM) dystonia scale score
Change in other movement disorder evaluated by the Clinical global impression (CGI) scale
(and 21 more...)

All

18 Years to 60 Years (Adult)

NCT02552628

69HCL14_0448

WILSTIM DBS

January 2016

January 2022

September 17, 2015

February 26, 2018

Hospices Civils de Lyon
Lyon, France

NCT01980433

Unknown ^†

Inhibitory rTMS in Dystonic Wilson Patients

Wilson Disease
Movement Disorders
Repetitive Transcranial Magnetic Stimulation

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Other: pre and post-rTMS electroencephalogram
Other: WCRS
(and 2 more...)

Interventional

Not Applicable

Assistance Publique - Hôpitaux de Paris

Other

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment

immediate and significant improvement in writing
significant improvement in writing
improvement of dystonia on the scale WDRS
correlation between the scores and the other parameters of disease severity

All

18 Years and older (Adult, Older Adult)

NCT01980433

P121105

WILSTIM

January 2014

February 2016

November 11, 2013

June 3, 2015

Hospital Lariboisiere
Paris, Ile de France, France

NCT00212368

Completed

Efficacy and Safety Study of Zinc Acetate to Treat Wilson's Disease in Japan.

Wison's Disease

Drug: Zinc acetate

Interventional

Phase 3

Nobelpharma

Industry

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

All

1 Year and older (Child, Adult, Older Adult)

NCT00212368

NPC-02-1

October 2004

August 2005

December 2005

September 21, 2005

September 10, 2010

NCT00001971

Recruiting

Evaluation of Patients With Liver Disease

Biliary Liver Cirrhosis
Hemochromatosis
Hepatitis
(and 2 more...)

Observational

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health Clinical Center (CC)

NIH

99999999

All

2 Years and older (Child, Adult, Older Adult)

NCT00001971

910214
91-DK-0214

September 10, 1991

January 19, 2000

May 3, 2018

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States

NCT02252380

Recruiting

ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders

Movement Disorders
Essential Tremor
Holmes Tremor
(and 6 more...)

Device: Transcranial ExAblate System

Interventional

Not Applicable

InSightec

Industry

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Severity of Device and Procedure Related Complications

All

18 Years to 85 Years (Adult, Older Adult)

NCT02252380

MD003

May 2015

December 2018

September 30, 2014

March 27, 2018

Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada

NCT03131427

Recruiting

China Registry for Genetic / Metabolic Liver Diseases

Genetic/Metabolic Liver Diseases

Drug: Standard of care

Observational

Beijing Friendship Hospital
Beijing YouAn Hospital
Henan Provincial Hospital
(and 10 more...)

Other

Observational Model: Cohort
Time Perspective: Prospective

rate of liver-related events of each disease.
Genotype profile in Chinese patients of each disease
Natural history of Chinese patients with each disease of different genotype
Causes of death in Chinese patients of each disease

20000

All

Child, Adult, Older Adult

NCT03131427

CR-GMLD

June 13, 2015

April 28, 2022

April 28, 2027

April 27, 2017

Beijing Ditan Hospital
Beijing, Beijing, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing, China
Peking University First Hospital
Beijing, Beijing, China
(and 9 more...)

† Study has passed its completion date and status has not been verified in more than two years.

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