Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05098028 | Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease | PHASE2 | COMPLETED | 44 | — | — | Mar 22, 2022 | Sep 4, 2023 | Sep 19, 2024 | 8 | United States, Canada +1 |
Maximum observed plasma concentration
| Arm | Type | Description |
|---|---|---|
| Low Dose Rifaximin ER | EXPERIMENTAL | twice daily |
| Low Dose Rifaximin DER | EXPERIMENTAL | twice daily |
| High Dose Rifaximin ER | EXPERIMENTAL | twice daily |
| High Dose Rifaximin DER | EXPERIMENTAL | twice daily |
| Placebo | PLACEBO_COMPARATOR | twice daily |
| Name | Type | Description |
|---|---|---|
| Low Dose Rifaximin ER | DRUG | Low Dose Rifaximin Extended Release Twice Daily |
| Low Dose Rifaximin DER | DRUG | Low Dose Rifaximin Delayed Extended Release Twice Daily |
| High Dose Rifaximin ER | DRUG | High Dose Rifaximin Extended Release Twice Daily |
| High Dose Rifaximin DER | DRUG | High Dose Rifaximin Delayed Extended Release Twice Daily |
| Placebo | DRUG | Placebo Twice Daily |
Inclusion Criteria: 1. ability and willingness to sign a written informed consent form. 2. between the ages of 18 to 70 years old (inclusive) at the time of consent. 3. SCD of any genotype (HbSS, HbSC, HbS β-thalassemia). If the subject's genotype has not been previously documented, genotyping will...