Trials / Completed
CompletedNCT01124643
Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease
An Open-label Extension of Study TKT028 Evaluating Safety and Clinical Outcomes of Replagal® Enzyme Replacement Therapy Administered to Adult Patients With Fabry Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate safety and clinical outcomes of treatment with Replagal in adult participants with Fabry disease who have completed Study TKT028 (NCT00864851).
Detailed description
HGT-REP-060 was designed to provide participants who participated in TKT028 an additional 52 weeks of treatment with Replagal at the standard dose of 0.2 milligram per kilogram (mg/kg) every other week (EOW) to assess the effect of continued Replagal therapy on long-term safety and clinical outcomes for this participant population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Replagal | 0.2 mg/kg administered intravenously \[IV\] every other week |
Timeline
- Start date
- 2010-04-13
- Primary completion
- 2013-07-08
- Completion
- 2013-07-08
- First posted
- 2010-05-17
- Last updated
- 2021-06-08
- Results posted
- 2014-08-22
Locations
9 sites across 7 countries: United States, Australia, Czechia, Finland, Poland, Slovenia, United Kingdom
Source: ClinicalTrials.gov record NCT01124643. Inclusion in this directory is not an endorsement.