NCT05098028

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Low Dose Rifaximin ER	Low Dose Rifaximin Extended Release Twice Daily
DRUG	Low Dose Rifaximin DER	Low Dose Rifaximin Delayed Extended Release Twice Daily
DRUG	High Dose Rifaximin ER	High Dose Rifaximin Extended Release Twice Daily
DRUG	High Dose Rifaximin DER	High Dose Rifaximin Delayed Extended Release Twice Daily
DRUG	Placebo	Placebo Twice Daily

Timeline

• Start date: 2022-03-22
• Primary completion: 2023-09-04
• Completion: 2023-09-04
• First posted: 2021-10-28
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

8 sites across 3 countries: United States, Canada, Kenya

Regulatory

• FDA-regulated drug study