Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease

ClinicalTrials.gov ID: NCT05098028

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT05098028
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Bausch Health Americas, Inc.; Industry
Enrollment: 44 participants

Conditions and interventions

Conditions

Sickle Cell Disease

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 70 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 22, 2022 (Actual)
Primary completion: Sep 4, 2023 (Actual)
Completion: Sep 4, 2023 (Actual)
Last update posted: Sep 19, 2024

2022 – 2023

United States locations

U.S. sites: 5
U.S. states: 5
U.S. cities: 5

Facility	City	State	ZIP	Site status
Bausch Site 105	Orange	California	92868	—
Bausch Site 103	Denver	Colorado	80220	—
Bausch Site 104	Atlanta	Georgia	30329	—
Bausch Site 101	Syracuse	New York	13210	—
Bausch Site 102	Greenville	North Carolina	27834	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05098028, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 19, 2024 · Synced Nov 15, 2026