CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Low Dose Rifaximin ER +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05098028
NCT05098028Phase 2Completed

A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Characterize the Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease

Bausch Health Americas, Inc.·interventional·Posted Oct 28, 2021·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Low Dose Rifaximin ER, Low Dose Rifaximin DER, and 3 other interventions for Sickle Cell Disease. Completed, enrolled 44 participants across 8 sites in 3 countries.

Detailed Summary

This is a randomized, double-blind, placebo-controlled study in sickle cell disease participants with a history of Vaso-occlusive Crises (VOCs). Approximately 60 participants with sickle cell disease will be enrolled and randomized: 12 participants in each of four active novel formulation rifaximin groups and 6 participants in each of 2 placebo groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Kenya, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedOct 28, 2021
Enrollment StartMar 22, 2022
Primary CompletionSep 4, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.7 years ago

Interventions

Low Dose Rifaximin ERdrug

Low Dose Rifaximin Extended Release Twice Daily

Low Dose Rifaximin DERdrug

Low Dose Rifaximin Delayed Extended Release Twice Daily

High Dose Rifaximin ERdrug

High Dose Rifaximin Extended Release Twice Daily

High Dose Rifaximin DERdrug

High Dose Rifaximin Delayed Extended Release Twice Daily

Placebodrug

Placebo Twice Daily