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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01124643 |
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Date of registration:
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23/04/2010 |
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Primary sponsor: |
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Public title:
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Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease
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Scientific title:
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An Open-label Extension of Study TKT028 Evaluating Safety and Clinical Outcomes of Replagal® Enzyme Replacement Therapy Administered to Adult Patients With Fabry Disease |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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43 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01124643 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Czech Republic
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Finland
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Paraguay
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Poland
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Slovenia
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United Kingdom
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United States
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Contacts
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Name:
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Lubor Golan |
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Address:
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Telephone:
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Email:
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Affiliation:
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1st School of Medicine, Charles University, Prague |
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Name:
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Bojan Vujkovac, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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General Hospital Slovenj Gradec |
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Name:
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Derlis Emilio Gonzalez Rodriguez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Privado de Hematologia e Investigacion Clinica (IPHIC) |
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Name:
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Lidia Chojinowska |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instytut Kardiologii |
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Name:
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Kathleen Nicholls, MB.BS, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Melbourne Health |
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Name:
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Ozlem Goker-Alpan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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O & O Alpan LLC |
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Name:
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Reena Sharma, MD |
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Address:
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Email:
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Affiliation:
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Salford Royal NHS Foundation Trust |
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Name:
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Jacek Musial, MD, PhD |
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Address:
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Email:
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Affiliation:
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Szpital Uniwersytecki w Krakowie |
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Name:
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Myrl Holida, PA-C |
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Address:
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Email:
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Affiliation:
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University of Iowa |
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Name:
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Ilkka Kantola, MD, PhD |
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Address:
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Email:
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Affiliation:
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University of Turku |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Complete all study requirements and assessments for Study TKT028 less than 30 days
(+/- 7 days) prior to the first dose in this extension protocol
- Voluntarily signed an Institutional Review Board/Independent Ethics Committee-
approved informed consent form after all relevant aspects of the study have been
explained and discussed.
- Has received and tolerated at least 80% of the total planned Replagal infusions in
Study TKT028
- Female patients of child-bearing potential must agree to use a medically acceptable
method of contraception at all times during the study and must have a negative
pregnancy test at the time of study entry and as required throughout participation in
study
Exclusion Criteria:
- Has received treatment with any investigational drug (other than Replagal) or device
within 30 days prior to study entry.
- Is unable to comply with the protocol, (eg, is unable to return for safety
evaluations, or is otherwise unlikely to complete the study), as determined by the
Investigator
- Has a positive test for hepatitis B surface antigen (HBsAg), hepatitis C(HCV)
antibody, or human immunodeficiency virus (HIV) antibody
- Is pregnant or lactating
- Is morbidly obese, defined as body mass index (BMI) >39 kg/m2
- Has any safety or medical issues, as assessed by the Investigator, that
contraindicate participation in the study (eg, has experienced an adverse reaction to
treatment with Replagal or has a known hypersensitivity to any of the components of
Replagal
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fabry Disease
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Intervention(s)
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Biological: Replagal
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Primary Outcome(s)
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To evaluate the safety and effect of continued dosing with Replagal
[Time Frame: 52 weeks]
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Secondary Outcome(s)
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Effect on exercise tolerance as measured by maximal oxygen consumption and distance walked in meters
[Time Frame: 52 weeks]
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Secondary ID(s)
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HGT-REP-060
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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