Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease
Completed · Phase 3
Conditions studied: Fabry Disease
In brief
This study will evaluate safety and clinical outcomes of treatment with Replagal in adult participants with Fabry disease who have completed Study TKT028 (NCT00864851).
Key facts
- Study ID
- NCT01124643
- Run by
- Shire
- People needed
- 35
- Starts
- 2010-04-13
- Expected to finish
- 2013-07-08
- Last updated by the study team
- 2021-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 participants 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
You may not qualify if…
- 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
Where it is running
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- O&O Alpan LLC — Fairfax, Virginia, United States
- The Royal Melbourne Hospital — Parkville, Australia
- 1st School of Medicine Charles University — Prague, Czechia
- Turku University Central Hospital — Turku, Finland
- Szpital Uniwersytecki w Krakowie — Krakow, Poland
- Instytut Kardiologii, I Klinika Choroby Wiencowej — Warsaw, Poland
- General Hospital Slovenj Gradec — Slovenj Gradec, Slovenia
- Salford Royal NHS Foundation Trust — Salford, England, United Kingdom
Full record on ClinicalTrials.gov
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