Actively Recruiting
ADAPT Study: Long-term Safety Study of INZ-701 in Patients With ENPP1 Deficiency and ABCC6 Deficiency
Led by Inozyme Pharma · Updated on 2024-11-29
200
Participants Needed
5
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study (Study INZ701-304 \[ADAPT\]) is to assess the long-term safety of INZ-701 in patients with ENPP1 Deficiency or ABCC6 Deficiency who have received INZ-701 in an existing clinical study and choose to continue dosing for the potential treatment of their condition.
CONDITIONS
Official Title
ADAPT Study: Long-term Safety Study of INZ-701 in Patients With ENPP1 Deficiency and ABCC6 Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written or electronic informed consent before any study procedures
- Provide assent if under 18 years old according to local regulations
- Male or female participants older than 1 year
- Must have completed required safety and efficacy periods of a prior INZ-701 clinical study for ENPP1 or ABCC6 Deficiency
- Female participants of childbearing potential must use effective contraception from one month before first dose through 30 days after last dose and agree not to donate ova during this time
- Male participants must use condoms from first dose through 30 days after last dose and agree not to donate sperm during this time
- Able to complete all study aspects in the opinion of the Investigator
You will not qualify if you...
- Presence of any significant disease or lab abnormality unrelated to ENPP1 or ABCC6 Deficiency that could affect study participation or results
- Known intolerance to INZ-701 or its ingredients
- Participation in another interventional clinical study or use of investigational drugs/devices within specified timeframes before first dose
- Pregnant, trying to become pregnant, or breastfeeding
- Male participants trying to father a child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Clinilabs Drug Development Corporation
Eatontown, New Jersey, United States, 07724
Actively Recruiting
3
Necker-Enfants Malades Hospital
Paris, France
Actively Recruiting
4
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
Actively Recruiting
5
VCTC
Oxford, United Kingdom
Actively Recruiting
Research Team
I
Inozyme Clinical Trial Information
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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