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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-New Enrollment Study


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General
Study Status Progress Adequate
Application Number H130001 / PAS001
Date Current Protocol Accepted 08/24/2015
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective of the study is to assess the safety of Lixelle column in patients with (dialysis-related amyloidosis) DRA in the US. The secondary objective of the study is to assess the probable benefit of Lixelle column to increase the 2M reduction rate in a single dialysis session.



This is a new enrollment study. This is a prospective study with two arms; DRA patients treated with Lixelle column (treatment arm) and DRA patients treated with conventional hemodialysis(HD) (natural history arm)

Study Population Description Treatment arm will consist of patients treated with Lixelle column. Control arm will consist of patients treated with conventional HD who reject Lixelle treatment but accept follow-up questionnaire.

Sample Size 30 DRA patients treated with Lixelle column (study arm) and 10 DRA patients treated with conventional HD. The sample size is based on clinical considerations and is not statistically driven.

Data Collection Primary endpoint

The primary endpoint is the rate of every SAE in the through 2 years of Lixelle treatment during the study period. The data will be assessed by descriptive statistics and will be compared to the SAE rate observed in the natural history arm.

Secondary endpoints

There are three secondary endpoints to assess the probable benefit of Lixelle in serum 2M reduction rate in a single Lixelle-treatment:

1. In study arm, 2M reduction rates obtained in Stage 2 (2nd week to 7th week) will be statistically compared with that in Stage 1 (1st week).

2. In study arm, 2M reduction rates obtained in Stage 3 (any week from 46th to 53rd week) will be statistically compared with that in Stage 1.

3. Differences in 2M reduction rates will be statistically compared between Stage 1 and Stage 3 in the natural history arm and study arm respectively.

Follow-up Visits and Length of Follow-up Patients will be followed for 2 years


OSB Lead-New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/03/2015 08/31/2015 On Time
one year report 03/04/2016 02/25/2016 On Time
18 month report 09/02/2016 08/25/2016 On Time
two year report 03/04/2017 02/21/2017 On Time
three year report 03/04/2018    
four year report 03/04/2019    
Final Report 05/24/2019    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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