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Liver CirrhosisPhase 2/3RECOVERNCT01897051

Rifaximin and Propranolol Combination Therapy Versus Propranolol Monotherapy in Cirrhotic Patients

A Phase 2/3 study testing Rifaximin + propranolol in people with Liver Cirrhosis and Portal Hypertension, run by Yonsei University at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To reduce portal pressure, the only recommended medication is nonselective beta blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor response rate and compliance. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Liver Cirrhosis, Portal Hypertension
What is being tested?
Rifaximin + propranolol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
2 sitesSouth Korea
Study dates
Jul 2013to Jun 2017
Phase
Phase 2/3
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 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Liver cirrhosis:diagnosed based on histology or unequivocal clinical, sonographic, and laboratory findings
  • 19≤age≤75
  • Hepatic venous pressure gradient > 12 mmHg
  • Informed consent

Who cannot join

  • Shock status requiring vasopressor
  • Active infection, for example Spontaneous bacterial peritonitis
  • Acute renal failure patients of any cause
  • Clinically relevant coronary artery disease(NYHA functional angina classification III/IV),congestive heart failure NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the past 12 months
  • Poorly controlled hypertension (BP 150/100mmHg)
  • Hepatocellular carcinoma
Show all 13Show fewer
  • History of another primary malignancy ≤ 3years
  • Medical or psychological conditions that would not permit the subject to complete thte study or sign informed consent
  • Pregnancy or lactation period
  • Serum creatinine ≧ 6mg/dL
  • Involvement in the conduct of other study within 30 days
  • Known hypersensitivity to Rifaximin or propranolol
  • Dysarrhythmia, inappropriate for study on investigator's judgment

Trial locations and contacts

2 sites in 1 country.

Moon Young Kim, MD,PhD contact

82-33-741-1225

drkimmy@yonsei.ac.kr

South Korea2 sites, 2 recruiting

  • Yonsei University Wonju Severance Cristian Hospital

    Wŏnju, Gangwon-do, 220-701

    Moon Young Kim, MD,PhD, 82-33-741-1225, drkimmy@yonsei.ac.kr

    Moon Young Kim, MD,PhD

    Not yet recruiting

  • Wonju Severance Christian Hospital

    Wŏnju

    Moon Young Kim, MD., PhD.

    Recruiting

Other trials in South Korea

About this study

Official title: Hemodynamic Response of Rifaximin and Non-selective β-blocker Combination Therapy Versus Non-selective β-blocker Monotherapy in Cirrhotic Patients With Esophageal Varices

To reduce portal pressure, the only recommended medication is nonselective beta blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor response rate and compliance.

Recent literature has supported the role of bacterial translocation as a mediator of splanchnic vasodilatation and portal hypertension. This stimulates the release of pro-inflammatory cytokines and the activation of the vasodilator NO resulting in a more pronounced deterioration of the baseline hyperdynamic circulatory state. Selective gut decontamination with Rifaximin can induce inhibition of bacterial translocation and associated worsening of portal hypertension. The investigators hypothesized that Rifaximin plus NSBB could result in decrease of portal pressure in cirrhotic patients with esophageal varices.

Being tested
Rifaximin + propranolol, Propranolol + Placebo
Keywords
Liver cirrhosis, Portal hypertension, Hepatic Venous Pressure Gradient, Rifaximin
Medical subject headings
Liver Cirrhosis, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rifaximin + propranololDrug

    Also called Normix, Propranolol

    1. Rifaximin : taking 400mg three times a day in the study period (total 1,200 mg per day)
    2. Propranolol : taking 40mg twice a day to start. If patient is tolerable and systolic blood pressure is above 90 mmHg, the dosage can be increased by doubling to every other day upto the 360mg per day. (Target heart rate : 25% reduction in baseline heart rate or at least 55 times per minute).

    If patient is not tolerable, we can reduce the dosage step-by-step until the adverse symptoms is disappeared.

  • Propranolol + PlaceboDrug

    Also called Non-selective beta-blocker, Placebo of Rifaximin

    1. Placebo of Rifaximin : taking 400mg three times a day in the study period (total 1,200 mg per day)
    2. Propranolol : taking 40mg twice a day to start. If patient is tolerable and systolic blood pressure is above 90 mmHg, the dosage can be increased by doubling to every other day upto the 360mg per day. (Target heart rate : 25% reduction in baseline heart rate or at least 55 times per minute).

    If patient is not tolerable, we can reduce the dosage step-by-step until the adverse symptoms is disappeared.

Study groups in NCT01897051
Study groupRoleWhat they receive
Combination therapyExperimentalRifaximin(normix®)+nonselective beta-blocker(Propranolol)
Receives: Drug: Rifaximin + propranolol
MonotherapyPlacebo comparatornonselective beta-blocker(Propranolol) + Placebo(of Rifaximin)
Receives: Drug: Propranolol + Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hepatic vein pressure gradient(HVPG)

    After measurement of baseline HVPG, patients will be randomized to treatment group of Rifaximin + Propranolol or Propranolol + Placebo. And 6 weeks after treatment, follow-up measurement of HVPG will be performed to evaluate efficacy of two regimens

    Measured: Change from baseline heptic vein pressure gradient at 6 weeks

Secondary outcomes (1)

  1. occurence of gastrointestinal bleeding

    when gastrointestinal bleeding occurs, after initiation of treatment, endoscopy will be performed to evaluate status of bleeding

    Measured: upto 6 months after initiation of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionFeb 2017 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897051
Sponsor's protocol ID
CR310037
Acronym
RECOVER
Status last verified
Apr 2015
First submitted
1 Jul 2013
Last updated
21 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Rasaratnam B, Kaye D, Jennings G, Dudley F, Chin-Dusting J. The effect of selective intestinal decontamination on the hyperdynamic circulatory state in cirrhosis. A randomized trial. Ann Intern Med. 2003 Aug 5;139(3):186-93. doi: 10.7326/0003-4819-139-3-200308050-00008.

    PubMed 12899586

  • Vlachogiannakos J, Saveriadis AS, Viazis N, Theodoropoulos I, Foudoulis K, Manolakopoulos S, Raptis S, Karamanolis DG. Intestinal decontamination improves liver haemodynamics in patients with alcohol-related decompensated cirrhosis. Aliment Pharmacol Ther. 2009 May 1;29(9):992-9. doi: 10.1111/j.1365-2036.2009.03958.x. Epub 2009 Feb 7.

    PubMed 19210289

  • Gonzalez A, Augustin S, Perez M, Dot J, Saperas E, Tomasello A, Segarra A, Armengol JR, Malagelada JR, Esteban R, Guardia J, Genesca J. Hemodynamic response-guided therapy for prevention of variceal rebleeding: an uncontrolled pilot study. Hepatology. 2006 Oct;44(4):806-12. doi: 10.1002/hep.21343.

    PubMed 17006916

  • Ripoll C, Banares R, Rincon D, Catalina MV, Lo Iacono O, Salcedo M, Clemente G, Nunez O, Matilla A, Molinero LM. Influence of hepatic venous pressure gradient on the prediction of survival of patients with cirrhosis in the MELD Era. Hepatology. 2005 Oct;42(4):793-801. doi: 10.1002/hep.20871.

    PubMed 16175621

  • Kumar M, Kumar A, Hissar S, Jain P, Rastogi A, Kumar D, Sakhuja P, Sarin SK. Hepatic venous pressure gradient as a predictor of fibrosis in chronic liver disease because of hepatitis B virus. Liver Int. 2008 May;28(5):690-8. doi: 10.1111/j.1478-3231.2008.01711.x.

    PubMed 18433395

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rifaximin + propranolol in people with Liver Cirrhosis and Portal Hypertension, run by Yonsei University at 2 sites in South Korea.

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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 21 Apr 2015. 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 South Korea. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Moon Young Kim, MD,PhD (82-33-741-1225, drkimmy@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hepatic vein pressure gradient(HVPG) (time frame: Change from baseline heptic vein pressure gradient at 6 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 NCT01897051, which also lists 5 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 21 Apr 2015.

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