Freedom of Information request on the study protocol, amendments, related study manuals and clinical study report for clinical trial GS-US-174-0149 (FOI 21-732)
Updated 27 April 2022
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16th July 2021
FOI 21/732
Dear
Thank you for your information request, dated 28 June 2021, where you asked for the study protocol, amendments, related study manuals and clinical study report for clinical trial GS-US-174-0149 (ClinicalTrials.gov Identifier: NCT01277601).
I am pleased to provide you with some of the information requested, as listed below.
• Clinical study report for clinical trial GS-US-174-0149 • Protocol Amendment 1; 12 January 2011 • Protocol Amendment 2; 15 April 2011 • Protocol Amendment 3; 02 August 2011 • Protocol Amendment 4.1; Europe; 20 February 2012 • Protocol Amendment 5.1; Europe; 29 June 2012 • Protocol Amendment 6.1; Europe; 17 May 2013
These documents are provided with any personal information or sensitive data redacted.
The study manuals are not provided because they are not regulatory documents and are not submitted to or held by the MHRA.
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MHRA Customer Service Centre
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