Thrombocytopenia Related to Chronic Liver DiseasePhase 4NCT07791940
Effect of Rifaximin on Thrombocytopenia in Patients With HCV-Related Liver Cirrhosis
A Phase 4 study testing Rifaximin (drug) in people with Thrombocytopenia Related to Chronic Liver Disease, run by Fayoum University Hospital at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thrombocytopenia Related to Chronic Liver Disease
- What is being tested?
- Rifaximin (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 19 Oct 2015to 30 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1) Evidence of bacterial infections in the body by:-
- Clinical history
- Physical examination
- Laboratory investigations:
- WBCs (total and differential count)
- CRP.
Show all 12Show fewer
- Urine analysis.
- Chest X-ray.
- Ascitic fluid analysis (WBCs \& culture and sensitivity) 2) History of variceal bleeding within the 2 weeks preceding this study. 3) Treatment with an antibiotic (including rifaximin) or agents which could have modified the inflammatory process or cytokines (pentoxifylline, steroidal or non-steroidal anti-inflammatory or immunosuppressive drugs) during the last 8 weeks before inclusion.
- 4) Evidence of neoplasia, including hepatocellular carcinoma (HCC). 5) History of red cell or plasma transfusion in the month prior to inclusion in this study.
- 6) History of significant cardiac, pulmonary, renal, or metabolic comorbidities.
- 7) 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine, Fayoum University Hospital
Al Fayyum, 63514
Faculty of Medicine, Beni Suef University Hospital
Banī Suwayf
About this study
Official title: Evaluation of the Role of Rifaximin on Thrombocytopenia in Patients With Hepatitis C-Related Liver Cirrhosis
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.
Read the detailed description
After approval by the Ethics Committee of the Faculty of Medicine, Fayoum University, patients were recruited from two tertiary university hospitals in Egypt. Written informed consent was obtained from all patients before enrolment. This was a double-blind, randomised controlled clinical trial that included 165 adults aged 18-75 years with HCV-related liver cirrhosis and thrombocytopenia who had previously received treatment for HCV and achieved a sustained virologic response.
Cirrhosis was diagnosed based on clinical findings (splenomegaly, ascites, and/or esophageal varices), laboratory findings (hypoalbuminemia, hyperbilirubinemia, and/or prolonged prothrombin time), and imaging findings on abdominal ultrasonography, computed tomography, and/or magnetic resonance imaging, with liver biopsy considered when available. The severity of cirrhosis was assessed using the Child-Pugh classification.
Thrombocytopenia was defined as a platelet count <150,000/mm³ and classified as mild (>75,000/mm³), moderate (50,000-75,000/mm³), or severe (<50,000/mm³). Anaemia was defined as haemoglobin <13.5 g/dL in men and <11.5 g/dL in women, and leukopenia as a white blood cell count <4,000/mm³.
Patients were randomly assigned in a 1:1 allocation ratio to the rifaximin group (n=100), which received rifaximin 550 mg orally twice daily for 4 weeks, or the placebo group (n=100). At baseline, all patients underwent clinical evaluation, complete blood count, liver and kidney function tests, and abdominal ultrasonography. A follow-up complete blood count was performed after 4 weeks. Patients were followed weekly in the outpatient hepatology clinic to assess treatment compliance, adverse effects, and cirrhosis-related complications
- Being tested
- Rifaximin (drug), Rifaximin Placebo
- Keywords
- Rifaximin, Thrombocytopenia, HCV, Liver cirrhosis
- Medical subject headings
- Thrombocytopenia, Hepatitis C, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin (drug)Drug
Also called Xifaxan
Rifaximin 550 mg tab twice daily for four weeks
Rifaximin PlaceboOther
Twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Participants received rifaximin 550 mg orally twice daily for 4 weeks. Receives: Drug: Rifaximin (drug) |
| Rifaximin Placebo | Placebo comparator | Participants received a placebo twice daily for 4 weeks. Receives: Other: Rifaximin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks of treatment
Secondary outcomes (4)
Impact of rifaximin treatment for 4 weeks on haemoglobin level
Change in haemoglobin level from baseline to 4 weeks in the rifaximin and placebo groups.
Measured: Four weeks of treatment
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and tolerability are evaluated by recording the number of participants experiencing adverse drug reactions. Participants are monitored during weekly outpatient follow-up visits to assess for drug reactions and cirrhosis-related complications. Adverse events are classified according to the Medical Dictionary for Regulatory Activities (MedDRA), version 26.1, using the appropriate System Organ Class and Preferred Term.
Measured: 4 weeks
Impact of Rifaximin treatment for four weeks on white blood cell count
Change in white blood cell count from baseline to 4 weeks in the rifaximin and placebo groups.
Measured: Four weeks of treatment
Treatment Adherence Rate
Treatment adherence is evaluated during weekly outpatient follow-up visits. Compliance is defined as the intake of ≥75% of the prescribed study medication during the overall treatment period.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start19 Oct 2015
- Primary completion30 Nov 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Thrombocytopenia Related to Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mahmoud Fares, Fayoum University Hospital
- Investigators
- Ahmed A. Gomaa, MD, Principal investigator, Faculty of Medicine, Fayoum UniversityMohamed M. Tawfiq, MD, Principal investigator, Faculty of Medicine, Beni Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791940
- Sponsor's protocol ID
- FUH M118
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qamar AA, Grace ND. Abnormal hematological indices in cirrhosis. Can J Gastroenterol. 2009 Jun;23(6):441-5. doi: 10.1155/2009/591317.
PubMed 19543577Koo 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.
PubMed 19881343Afdhal 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.
PubMed 18433919Kalambokis 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.
PubMed 20832949Garcia-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.
PubMed 15123075Kalambokis 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.
PubMed 21131941Witters 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.
PubMed 18331464Liangpunsakul 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.
PubMed 14501224Balabaud 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.
PubMed 20537484
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Rifaximin on Thrombocytopenia in Patients With Hepatitis C-Related Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT07791940
- Acronym / sponsor ID
- FUH M118
- Keywords
- Rifaximin, Thrombocytopenia, HCV, Liver cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After approval by the Ethics Committee of the Faculty of Medicine, Fayoum University, patients were recruited from two tertiary university hospitals in Egypt. Written informed consent was obtained from all patients before enrolment. This was a double-blind, randomised controlled clinical trial that included 165 adults aged 18-75 years with HCV-related liver cirrhosis and thrombocytopenia who had previously received treatment for HCV and achieved a sustained virologic response.
Cirrhosis was diagnosed based on clinical findings (splenomegaly, ascites, and/or esophageal varices), laboratory findings (hypoalbuminemia, hyperbilirubinemia, and/or prolonged prothrombin time), and imaging findings on abdominal ultrasonography, computed tomography, and/or magnetic resonance imaging, with liver biopsy considered when available. The severity of cirrhosis was assessed using the Child-Pugh classification.
Thrombocytopenia was defined as a platelet count <150,000/mm³ and classified as mild (>75,000/mm³), moderate (50,000-75,000/mm³), or severe (<50,000/mm³). Anaemia was defined as haemoglobin <13.5 g/dL in men and <11.5 g/dL in women, and leukopenia as a white blood cell count <4,000/mm³.
Patients were randomly assigned in a 1:1 allocation ratio to the rifaximin group (n=100), which received rifaximin 550 mg orally twice daily for 4 weeks, or the placebo group (n=100). At baseline, all patients underwent clinical evaluation, complete blood count, liver and kidney function tests, and abdominal ultrasonography. A follow-up complete blood count was performed after 4 weeks. Patients were followed weekly in the outpatient hepatology clinic to assess treatment compliance, adverse effects, and cirrhosis-related complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: Rifaximin (drug)Participants received rifaximin 550 mg orally twice daily for 4 weeks. |
| Rifaximin Placebo | Placebo comparator | Other: Rifaximin PlaceboParticipants received a placebo twice daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 1) Evidence of bacterial infections in the body by:-
- Clinical history
- Physical examination
- Laboratory investigations:
- 4) Evidence of neoplasia, including hepatocellular carcinoma (HCC). 5) History of red cell or plasma transfusion in the month prior to inclusion in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin (drug)Also: XifaxanRifaximin 550 mg tab twice daily for four weeks | Drug | Rifaximin |
| Rifaximin PlaceboTwice daily for 4 weeks | Other | Rifaximin Placebo |
Primary outcome
Impact of Rifaximin treatment for four weeks on platelet count
Time frame: Four weeks of treatment
Change in platelet count from baseline to 4 weeks in the rifaximin and placebo groups.
4 secondary outcomes
Impact of rifaximin treatment for 4 weeks on haemoglobin level
Time frame: Four weeks of treatment
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 4 weeks
Impact of Rifaximin treatment for four weeks on white blood cell count
Time frame: Four weeks of treatment
Treatment Adherence Rate
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 19543577Qamar AA, Grace ND. Abnormal hematological indices in cirrhosis. Can J Gastroenterol. 2009 Jun;23(6):441-5. doi: 10.1155/2009/591317.
- Background: PubMed 19881343Koo 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.
- Background: PubMed 18433919Afdhal 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.
- Background: PubMed 20832949Kalambokis 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.
- Background: PubMed 15123075Garcia-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.
- Background: PubMed 21131941Kalambokis 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.
- Background: PubMed 18331464Witters 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.
- Background: PubMed 14501224Liangpunsakul 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.
- Background: PubMed 20537484Balabaud 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A. Gomaa, MD principal investigator
Faculty of Medicine, Fayoum University
Mohamed M. Tawfiq, MD principal investigator
Faculty of Medicine, Beni Suef University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin (drug) in people with Thrombocytopenia Related to Chronic Liver Disease, run by Fayoum University Hospital at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Rifaximin treatment for four weeks on platelet count (time frame: Four weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07791940, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.