Rifaximin to Modify the Disease Course in Sickle Cell Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03719729|
Recruitment Status : Unknown
Verified August 2018 by New York Medical College.
Recruitment status was: Recruiting
First Posted : October 25, 2018
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Antibiotics||Drug: Rifaximin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Rifaximin (Xifaxan) for Patients With Sickle Cell Disease (SCD)|
|Actual Study Start Date :||August 22, 2018|
|Estimated Primary Completion Date :||February 22, 2020|
|Estimated Study Completion Date :||July 22, 2020|
Each subject will receive rifaximin 550 mg twice a day for up to one year.
Administer daily rifaximin to modify intestinal microbiome to alter the course of the disease.
Other Name: Xifaxan
- Toxicity profile [ Time Frame: 24 months ]Incidence of nausea, vomiting, diarrhea, abdominal discomfort, worsening anemia.
- Changes in the annual rate of hospital admission for painful crisis [ Time Frame: 12 months ]Changes in the frequency of hospitalization for painful crisis
- Changes in the annual days of hospitalization for painful crisis [ Time Frame: 12 months ]Changes in the total number of days in hospital due to painful crisis
- Changes in the annual number of units of blood transfusion [ Time Frame: 12 months ]Changes in the number of units of blood transfused
- Changes in the quality of life as measured by the FANLTC questionnaire [ Time Frame: 24 months ]Changes in the quality of life due to treatment with rifaximin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719729
|Contact: Seah Lim, MD PhDfirstname.lastname@example.org|
|Contact: Judy Mooreemail@example.com|
|United States, New York|
|Westchester Medical Cancer Cancer Institute||Recruiting|
|Valhalla, New York, United States, 10532|
|Contact: Seah Lim, MD PhD 914-246-6600 firstname.lastname@example.org|
|Contact: Bettina Knoll, MD PhD email@example.com|
|Principal Investigator: Seah Lim, MD PhD|
|Sub-Investigator: Bettina Knoll, MD PhD|