Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-13

Study Completion Date

2013-07-08

Brief Summary

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This study will evaluate safety and clinical outcomes of treatment with Replagal in adult participants with Fabry disease who have completed Study TKT028 (NCT00864851).

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Detailed Description

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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

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Fabry Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Replagal 0.2 mg/kg EOW

Intravenous, 0.2mg/kg EOW

Group Type EXPERIMENTAL

Replagal

Intervention Type BIOLOGICAL

0.2 mg/kg administered intravenously \[IV\] every other week

Interventions

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Replagal

0.2 mg/kg administered intravenously \[IV\] every other week

Intervention Type BIOLOGICAL

Other Intervention Names

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algalsidase alfa alpha-Galactosidase DRX005B

Eligibility 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 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No