Effect of Rifaximin on Thrombocytopenia in Patients With HCV-Related Liver Cirrhosis

NCT07791940 | Completed Phase 4

• 1 other identifier: FUH M118
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

Brief Summary

Cirrhosis is a common complication of chronic hepatitis C virus (HCV) infection in Egypt. Thrombocytopenia (TP) is the most common cytopenia in patients with cirrhosis and may be associated with variceal bleeding, rebleeding, morbidity, and mortality. Although TP has traditionally been attributed to portal hypertension and splenic sequestration, other mechanisms include impaired thrombopoietin activity, bone marrow suppression, and increased platelet destruction. Rifaximin is a poorly absorbed, broad-spectrum intestinal antimicrobial agent widely used in patients with cirrhosis, particularly for hepatic encephalopathy. Its minimal systemic absorption limits systemic adverse effects. Rifaximin may reduce intestinal bacterial overgrowth and bacterial translocation, thereby decreasing circulating endotoxin and proinflammatory cytokines that may contribute to haematological abnormalities in cirrhosis. Previous observations have suggested that intestinal decontamination with rifaximin may increase platelet counts in patients with cirrhosis and thrombocytopenia. This randomised controlled trial was designed to investigate whether rifaximin treatment could improve platelet count in patients with HCV-related liver cirrhosis and thrombocytopenia.

Conditions

Thrombocytopenia Related to Chronic Liver Disease

Keywords

Rifaximin, Thrombocytopenia, HCV, Liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• Impact of Rifaximin treatment for four weeks on platelet count

  Change in platelet count from baseline to 4 weeks in the rifaximin and placebo groups.

  Four weeks of treatment

Secondary Outcomes (4)

• Impact of rifaximin treatment for 4 weeks on haemoglobin level

  Four weeks of treatment

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  4 weeks

• Impact of Rifaximin treatment for four weeks on white blood cell count

  Four weeks of treatment

• Treatment Adherence Rate

  Four weeks

Study Arms (2)

Rifaximin

EXPERIMENTAL

Participants received rifaximin 550 mg orally twice daily for 4 weeks.

Drug: Rifaximin (drug)

Rifaximin Placebo

PLACEBO COMPARATOR

Participants received a placebo twice daily for 4 weeks.

Other: Rifaximin Placebo

Interventions

Rifaximin (drug) DRUG

Rifaximin 550 mg tab twice daily for four weeks

Also known as: Xifaxan

Rifaximin

Rifaximin Placebo OTHER

Twice daily for 4 weeks

Rifaximin Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of liver cirrhosis was based on a combination of clinical findings (e.g., splenomegaly, ascites, and/or oesophageal varices), laboratory investigations, and imaging studies, including abdominal ultrasonography, computed tomography, or magnetic resonance imaging. Histological confirmation by liver biopsy was available in selected cases.

You may not qualify if:

• \) Evidence of bacterial infections in the body by:-
• Clinical history
• Physical examination
• Laboratory investigations:
• WBCs (total and differential count)
• CRP.
• Urine analysis.
• Chest X-ray.
• \) History of significant cardiac, pulmonary, renal, or metabolic comorbidities.
• \) overt hepatic encephalopathy. 8) Active alcohol consumption within the preceding six months. 9) Rifaximin hypersensitivity, 10) Active viral hepatitis requiring direct-acting antiviral therapy 11) Pregnancy or breastfeeding and HIV infection.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (2)

Faculty of Medicine, Fayoum University Hospital

Al Fayyum, 63514, Egypt

Location

Faculty of Medicine, Beni Suef University Hospital

Banī Suwayf, Egypt

Location

Related Publications (9)

• Qamar AA, Grace ND. Abnormal hematological indices in cirrhosis. Can J Gastroenterol. 2009 Jun;23(6):441-5. doi: 10.1155/2009/591317.

  PMID: 19543577 BACKGROUND

• Koo HL, DuPont HL. Rifaximin: a unique gastrointestinal-selective antibiotic for enteric diseases. Curr Opin Gastroenterol. 2010 Jan;26(1):17-25. doi: 10.1097/MOG.0b013e328333dc8d.

  PMID: 19881343 BACKGROUND

• Afdhal N, McHutchison J, Brown R, Jacobson I, Manns M, Poordad F, Weksler B, Esteban R. Thrombocytopenia associated with chronic liver disease. J Hepatol. 2008 Jun;48(6):1000-7. doi: 10.1016/j.jhep.2008.03.009. Epub 2008 Mar 31.

  PMID: 18433919 BACKGROUND

• Kalambokis G, Tsianos EV. Endotoxaemia in the pathogenesis of cytopenias in liver cirrhosis. Could oral antibiotics raise blood counts? Med Hypotheses. 2011 Jan;76(1):105-9. doi: 10.1016/j.mehy.2010.08.043. Epub 2010 Sep 15.

  PMID: 20832949 BACKGROUND

• Garcia-Tsao G, Wiest R. Gut microflora in the pathogenesis of the complications of cirrhosis. Best Pract Res Clin Gastroenterol. 2004 Apr;18(2):353-72. doi: 10.1016/j.bpg.2003.10.005.

  PMID: 15123075 BACKGROUND

• Kalambokis G, Tsianos EV. Thrombocytopenia associated with chronic liver disease: effects of rifaximin on platelet count. Am J Gastroenterol. 2010 Dec;105(12):2705-7. doi: 10.1038/ajg.2010.364. No abstract available.

  PMID: 21131941 BACKGROUND

• Witters P, Freson K, Verslype C, Peerlinck K, Hoylaerts M, Nevens F, Van Geet C, Cassiman D. Review article: blood platelet number and function in chronic liver disease and cirrhosis. Aliment Pharmacol Ther. 2008 Jun 1;27(11):1017-29. doi: 10.1111/j.1365-2036.2008.03674.x. Epub 2008 Mar 5.

  PMID: 18331464 BACKGROUND

• Liangpunsakul S, Ulmer BJ, Chalasani N. Predictors and implications of severe hypersplenism in patients with cirrhosis. Am J Med Sci. 2003 Sep;326(3):111-6. doi: 10.1097/00000441-200309000-00001.

  PMID: 14501224 BACKGROUND

• Balabaud C, Bioulac-Sage P. Cirrhosis: what else? Gastroenterol Clin Biol. 2010 Apr-May;34(4-5):252-4. doi: 10.1016/j.gcb.2010.03.007. Epub 2010 May 27.

  PMID: 20537484 BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia; Hepatitis C; Liver Cirrhosis

Interventions

Rifaximin; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Ahmed A. Gomaa, MD

  Faculty of Medicine, Fayoum University

  PRINCIPAL INVESTIGATOR

• Mohamed M. Tawfiq, MD

  Faculty of Medicine, Beni Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Endemic Medicine

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 28, 2026
• Study Start: October 19, 2015
• Primary Completion: December 30, 2016
• Study Completion: December 30, 2016
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)