Actively Recruiting
A Study of Replagal in Children and Adults With Fabry Disease in India
Led by Shire · Updated on 2025-09-19
5
Participants Needed
3
Research Sites
212 weeks
Total Duration
On this page
Sponsors
S
Shire
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main aim of this study is to learn more about the safety profile of Replagal. Participants will receive Replagal every 2 weeks at the clinic for about 1 year.
CONDITIONS
Official Title
A Study of Replagal in Children and Adults With Fabry Disease in India
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants of any age with confirmed Fabry disease diagnosis who have not received Replagal before and are not in any other free enzyme replacement therapy program
- Confirmed diagnosis based on gene mutation of alpha-galactosidase A or enzyme deficiency levels as specified
- Presence of clinical symptoms of Fabry disease as determined by the investigator
- Ability to understand and provide written informed consent or assent through a legal representative or guardian
- Female participants of childbearing potential must have a negative pregnancy test before starting treatment and agree to use two forms of contraception during the study
- Male participants who are sexually active with partners of childbearing potential must agree to use barrier contraception during the study
You will not qualify if you...
- Previous treatment with Replagal
- Poorly controlled high blood pressure as determined by the investigator
- Chronic kidney disease with very low kidney function (eGFR less than 15 mL/min/1.73 m²), history of kidney transplant, or current dialysis
- Serious liver disorders with abnormal liver test results exceeding defined limits and considered clinically significant
- Pregnant, breastfeeding, or intending to become pregnant or donate eggs during the study period for female participants
- Inability to understand the study or provide informed consent
- Inability or unwillingness to comply with study procedures or return for follow-up visits
- Intent to donate sperm during the study for male participants
- Participation in any other investigational drug trial within 4 weeks prior to screening
- Any other condition judged by the investigator to make the participant unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Institute of Child Health
Kolkata, India, 700017
Not Yet Recruiting
2
All India Institute of Medical Sciences (AIIMS)
New Delhi, India, 110029
Actively Recruiting
3
Sir Gangaram Hospital
New Delhi, India, 110060
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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