Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01865812
Pre Assignment Details:
Screening window was up to 20 days in duration to assess eligibility. Stable dose of ursodeoxycholic acid (UDCA) for 3 months prior to Day 0 was required. A 28-day washout period for bile acid sequestrants and no serum-lipid modifying agents for 3 months prior to Day 0 was also required. After the PTP, participants were offered the opportunity to enter the open-label, long-term safety extension (LTSE) phase of the study.
Recruitment Details:
Recruitment started 19-Nov-2013 and completed 16-May-2014 in the primary treatment phase (PTP). Thirty-three participants were screened and 27 enrolled.
Study:
NCT01865812
Study Brief:
Results Section:
NCT01865812