Follow on study in adault Fabry Disease patients

Phase 1

• Conditions: Fabry disease; MedDRA version: 14.0Level: PTClassification code 10016016Term: Fabry's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

• Registration Number: EUCTR2009-015985-75-GB
• Lead Sponsor: Shire Human Genetic Therapies (HGT), Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-19
• Study Completion: 2013-07-08
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Complete all study requirements and assessments for Study TKT028 less than 30 days (± 7 days) prior to the first dose in this extension protocol.
2. 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.
3. Has received and tolerated at least 80% of the total planned Replagal infusions in Study TKT028.
4. 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 their participation in the study.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 39
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Has received treatment with any investigational drug (other than Replagal) or device within 30 days prior to study entry.
2. 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.
3. Has a positive test for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antibody.
4. Is pregnant or lactating.
5. Is morbidly obese, defined as body mass index (BMI) >39 kg/m2.
6. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified