CirrhosisRFXMNCT02991612
Rifaximin in Patients With Gastroesophageal Variceal Bleeding
A study testing Rifaximin in people with Cirrhosis and Esophageal and Gastric Varices, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2016to 28 Feb 2018
- Phase
- Interventional
- 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
- 18 y.o. ≤age≤75 y.o.;
- Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N- butyl-cyanoacrylate injection).
Who cannot join
- age <18 y.o. or age > 75 y.o.;
- Never had the variceal bleeding episode before;
- Do not have endoscopic treatment;
- Combined with other malignant tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment);
- Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
- Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics.
- Acute variceal bleeding within 5 days.
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study
The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
Read the detailed description
Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection.
However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.
- Being tested
- Rifaximin
- Medical subject headings
- Fibrosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called XIFAXAN
Patients receive Rifaximin 400mg bid for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin Treatment Group | Experimental | Rifaximin 400mg bid for 2 months, Receives: Drug: Rifaximin |
| Control Group | No intervention | Receive routine endoscopic treatment without having rifaximin for 2 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all clinical adverse events
The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks
Measured: 8 weeks
Secondary outcomes (3)
Changes of portal vein thrombosis
complete or partial recanalization of thrombosis
Measured: 2 months
Changes of intestinal flora
Metagenomics sequencing
Measured: 2 months
The changes of serum level of cytokines
Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start25 Nov 2016
- Primary completion22 Dec 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyao Chen, Shanghai Zhongshan Hospital
- Investigators
- Shiyao CHEN, M.D., Principal investigator, Zhongshan Hospital, Fudan University, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991612
- Sponsor's protocol ID
- ZS-CSY-RFXM
- Acronym
- RFXM
- Status last verified
- May 2018
- First submitted
- 10 Dec 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Huang XQ, Ai YJ, Li F, Ye ST, Wang JH, Zhang R, Zhang W, Zhu YL, Chen SY. Impact of rifaximin on cirrhosis complications and gastric microbiota in patients with gastroesophageal variceal bleeding: A pilot randomized controlled trial. J Dig Dis. 2024 Aug;25(8):504-516. doi: 10.1111/1751-2980.13314.
PubMed 39443081Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
PubMed 37467180
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study
- ClinicalTrials.gov ID
- NCT02991612
- Acronym / sponsor ID
- RFXM / ZS-CSY-RFXM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
Detailed description
Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection.
However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin Treatment Group | Experimental | Drug: RifaximinRifaximin 400mg bid for 2 months, |
| Control Group | No intervention | –Receive routine endoscopic treatment without having rifaximin for 2 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 y.o. ≤age≤75 y.o.;
- Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N- butyl-cyanoacrylate injection).
Key exclusion criteria (8 listed)
- age <18 y.o. or age > 75 y.o.;
- Never had the variceal bleeding episode before;
- Do not have endoscopic treatment;
- Combined with other malignant tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment);
- Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
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 |
|---|---|---|
| RifaximinAlso: XIFAXANPatients receive Rifaximin 400mg bid for 2 months | Drug | Rifaximin Treatment Group |
Primary outcome
Incidence of all clinical adverse events
Time frame: 8 weeks
The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks
3 secondary outcomes
Changes of portal vein thrombosis
Time frame: 2 months
Changes of intestinal flora
Time frame: 2 months
The changes of serum level of cytokines
Time frame: 8 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 11 May 2018.
- Derived from this study: PubMed 39443081Huang XQ, Ai YJ, Li F, Ye ST, Wang JH, Zhang R, Zhang W, Zhu YL, Chen SY. Impact of rifaximin on cirrhosis complications and gastric microbiota in patients with gastroesophageal variceal bleeding: A pilot randomized controlled trial. J Dig Dis. 2024 Aug;25(8):504-516. doi: 10.1111/1751-2980.13314.
- Derived from this study: PubMed 37467180Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
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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.
Shiyao CHEN, M.D. principal investigator
Zhongshan Hospital, Fudan University, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifaximin in people with Cirrhosis and Esophageal and Gastric Varices, run by Shanghai Zhongshan Hospital at 1 site in China.
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 2 inclusion and 8 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Incidence of all clinical adverse events (time frame: 8 weeks). 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 NCT02991612, which also lists 2 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 11 May 2018.