Cirrhoses, LiverPhase 2LIVERHOPENCT03150459
Simvastatin Plus Rifaximin in Decompensated Cirrhosis
A Phase 2 study testing Simvastatin 20 mg, Simvastatin 40mg and Rifaximin 400 mg in people with Cirrhoses, Liver, run by Judit Pich at 9 sites in 6 countries.
Trial summary
The main purpose of this study is to investigate whether the combination of two different drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhoses, Liver
- What is being tested?
- Simvastatin 20 mg, Simvastatin 40mg and Rifaximin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 26 Jul 2017to 12 Mar 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Cirrhosis defined by standard clinical criteria and ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included. Patients with cirrhosis of autoimmune etiology on treatment with corticosteroids must be on stable corticosteroid dose for ≥3-month period before study inclusion.
- Child Pugh B/C patients (from 7 to 12 points).
- Women of child-bearing potential must have a negative pregnancy test in urine before the inclusion of the study and agree to use highly effective contraceptive methods (combined oral pill, injectable or implanted contraceptive, intrauterine device / intrauterine hormone-releasing system) during the study.
Who cannot join
- Patients on treatment with statins or rifaximin one month before study inclusion.
- Patients on the waiting list for liver transplantation.
- Patients with acute-on-chronic liver failure according to the criteria published by Moreau et al.
- Serum creatinine ≥2 mg/dL.
- Serum bilirubin>5 mg/dL.
- INR ≥2.5.
Show all 27Show fewer
- Patients with CK elevation of 50% or more above the upper limit of normal at study inclusion.
- Bacterial infection within 15 days before study inclusion.
- Gastrointestinal bleeding within 15 days before study inclusion.
- Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy.
- HIV infection.
- Hepatocellular carcinoma outside Milan criteria, defined as a single nodule ≤5 cm or a maximum of 3 nodules with none >3 cm.
- Patients on antiviral therapy for HCV or those who have received it within the last 6 months.
- Patients with previous history of myopathy.
- Patients on treatment with potent inhibitors of CYP3A4 enzyme (See section 5.2: Concomitant, nonpermitted and permitted medication)
- Patients on treatment with drugs with potential interactions with simvastatin
- Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
- Patients with current extrahepatic malignancies including solid tumours and hematologic disorders.
- Patients with previous history or increased risk of intestinal obstruction.
- Pregnancy or breastfeeding.
- Patients included in other clinical trials in the previous month.
- Patients with active alcohol consumption of more than 3 units per day.
- Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
- Severe alcoholic hepatitis requiring corticosteroid therapy (Maddrey's Discriminant function ≥ 32 and/or ABIC score > 6.7).
- Refusal to give informed consent.
- Patients with contraindications for statins or rifaximin.
- Known hypersensitivity to rifaxamin (or rifamycin derivatives) or to simvastatin.
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Italy3 sites
Bologna University Hospital
Bologna
Padova University Hospital
Padova, 35128
San Giovanni Battista Hospital
Torino, 10129
Spain2 sites
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
About this study
Official title: Safety and Tolerability of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis: a Multicenter, Double-blind, Placebo Controlled Randomized Clinical Trial.
The main purpose of this study is to investigate whether the combination of two different drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated cirrhosis.
The secondary purpose is to see if this combination results in an improvement in inflammation markers in patients with cirrhosis and in an improvement in analytic parameters of progression of liver disease.
Read the detailed description
Cirrhosis is the final stage of liver diseases, and currently, there is no effective treatment, with liver transplantation being the only curative solution in selected patients. As the number of donor organs for liver transplantation is limited and criteria for transplantation are strict, the current management of cirrhosis consists of treating its complications.
However, there is no effective therapy that prevents or cures the disease itself.
Rifaximin is an antibiotic that acts in the gastrointestinal tract. It is poorly absorbed to the general circulation and has low toxicity and good tolerability. Itis currently approved for use in patients with cirrhosis to prevent recurrent hepatic encephalopathy. Rifaximin decreases the transit of bacteria and bacterial products from the gut to the general circulation, preventing the chronic inflammation that takes place in cirrhotic patients.
Recent investigations have shown that simvastatin, a drug which is widely used to treat high cholesterol levels for the prevention of cardiovascular diseases, may have beneficial effects in patients with cirrhosis by preventing the progression of the disease and its complications. Although in the past decades there was a concern about its use in patients with liver disease due to its rare adverse effects (liver and muscle toxicity), recent clinical trials have shown that it can be safely used in patients with cirrhosis.
LIVERHOPE_SAFETY clinical trial have been designed to investigate whether the combination of these two drugs is safe in patients with cirrhosis, and also if it has potential beneficial effects in decreasing inflammation and improving analytical markers of progression of liver disease.
- Conditions
- Cirrhoses, Liver
- Being tested
- Simvastatin 20 mg, Simvastatin 40mg, Rifaximin 400 mg, Placebo of Simvastatin, Placebo of Rifaximin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 20 mgDrug
Simvastatin 20 mg/day for 12 weeks (Group 1)
Simvastatin 40mgDrug
Simvastatin 40 mg/day for 12 weeks (Group 2)
Rifaximin 400 mgDrug
Rifaximin 400 mg/8 hours for 12 weeks (Group 1 and 2)
Placebo of SimvastatinOther
Placebo of Simvastatin for 12 weeks (Group 3)
Placebo of RifaximinOther
Placebo of Rifaximin for 12 weeks (Group 3)
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin 20 mg + Rifaximin 400 mg (group 1) | Experimental | Simvastatin 20 mg/day and rifaximin 400 mg/8 hours orally for 12 weeks Receives: Drug: Simvastatin 20 mg; Drug: Rifaximin 400 mg |
| Simvastatin 40 mg + Rifaximin 400 mg (group 2) | Experimental | Simvastatin 40 mg/day and rifaximin 400 mg/8 hours orally for 12 weeks Receives: Drug: Simvastatin 40mg; Drug: Rifaximin 400 mg |
| Placebo of Simvastatin + Placebo of Rifaximin (group 3) | Placebo comparator | Placebo simvastatin and placebo rifaximin orally for 12 weeks Receives: Other: Placebo of Simvastatin; Other: Placebo of Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in transaminases during the treatment period, to evaluate treatment-related toxicity.
This quantitative analysis will consist of liver toxicity assessed by the development of liver injury defined as 3-fold increase in serum transaminases to a final value at least 3 times the upper normal limit
Measured: Week 12
Change from baseline in alkaline phosphatase during the treatment period, to evaluate treatment-related toxicity.
This quantitative analysis will consist of liver toxicity assessed by the development of liver injury defined as 2-fold increase in serum levels of alkaline phosphatase with respect to baseline value to a final value at least 2 times the upper normal limit
Measured: Week 12
Change from baseline in creatine kinase during the treatment period, to evaluate treatment-related toxicity.
This quantitative analysis will consist of muscle toxicity defined as 5-fold increase in creatine kinase (CK) levels during treatment
Measured: Week 12
Secondary outcomes (27)
Appearance of muscle toxicity at weeks 2, 4, 6, 8, 10 and 12 as defined using a specific statin-associated myopathy questionnaire
Measured: Weeks 2, 4, 6, 8, 10 and 12
Changes from baseline in plasma renin concentration levels at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in serum aldosterone levels at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in plasma norepinephrine levels at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in plasma copeptin levels at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, VCAM-1 and ICAM-1
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, VEGF-A
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, Fractalkine
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, MIP-1α
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, Eotaxin
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, IP-10
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, RANTES
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, GM-CSF
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, IL-1β, IL-2, IL-6 and IL-8
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, MCP-1
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, oxidized form of albumin
Measured: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, HNA2
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in plasma biomarker FABP4 at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in plasma biomarker CD-163 at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker NGAL at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker IL-18 at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker MCP-1 at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker osteopontin at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker albumin at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Changes in blood levels of bacterial DNA or bacterial products at weeks 2, 4, 8 and 12.
Measured: Weeks 2, 4, 8 and 12
Number of patients with genetic polymorphisms of statins membrane transporter OATPB1 in patients developing treatment-related toxicity (defined as the primary endpoint of the study).
Measured: Week 12
Proportion of patients with treatment-related serious adverse events during the study period.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start26 Jul 2017
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhoses, LiverStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II, multicenter, double-blind placebo controlled, randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Judit Pich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Judit Pich, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Investigators
- Pere Ginès, MD, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150459
- Sponsor's protocol ID
- LIVERHOPE_SAFETY
- Other IDs
- 2016-004499-23, 2016
- Acronym
- LIVERHOPE
- Status last verified
- Mar 2019
- First submitted
- 3 May 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pose E, Napoleone L, Amin A, Campion D, Jimenez C, Piano S, Roux O, Uschner FE, de Wit K, Zaccherini G, Alessandria C, Angeli P, Bernardi M, Beuers U, Caraceni P, Durand F, Mookerjee RP, Trebicka J, Vargas V, Andrade RJ, Carol M, Pich J, Ferrero J, Domenech G, Llopis M, Torres F, Kamath PS, Abraldes JG, Sola E, Gines P. Safety of two different doses of simvastatin plus rifaximin in decompensated cirrhosis (LIVERHOPE-SAFETY): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):31-41. doi: 10.1016/S2468-1253(19)30320-6. Epub 2019 Oct 10.
PubMed 31607677
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis: a Multicenter, Double-blind, Placebo Controlled Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03150459
- Acronym / sponsor ID
- LIVERHOPE / LIVERHOPE_SAFETY
- Conditions
- Cirrhoses, Liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Judit PichUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 12 May 2017 (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.
The main purpose of this study is to investigate whether the combination of two different drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated cirrhosis.
The secondary purpose is to see if this combination results in an improvement in inflammation markers in patients with cirrhosis and in an improvement in analytic parameters of progression of liver disease.
Detailed description
Cirrhosis is the final stage of liver diseases, and currently, there is no effective treatment, with liver transplantation being the only curative solution in selected patients. As the number of donor organs for liver transplantation is limited and criteria for transplantation are strict, the current management of cirrhosis consists of treating its complications.
However, there is no effective therapy that prevents or cures the disease itself.
Rifaximin is an antibiotic that acts in the gastrointestinal tract. It is poorly absorbed to the general circulation and has low toxicity and good tolerability. Itis currently approved for use in patients with cirrhosis to prevent recurrent hepatic encephalopathy. Rifaximin decreases the transit of bacteria and bacterial products from the gut to the general circulation, preventing the chronic inflammation that takes place in cirrhotic patients.
Recent investigations have shown that simvastatin, a drug which is widely used to treat high cholesterol levels for the prevention of cardiovascular diseases, may have beneficial effects in patients with cirrhosis by preventing the progression of the disease and its complications. Although in the past decades there was a concern about its use in patients with liver disease due to its rare adverse effects (liver and muscle toxicity), recent clinical trials have shown that it can be safely used in patients with cirrhosis.
LIVERHOPE_SAFETY clinical trial have been designed to investigate whether the combination of these two drugs is safe in patients with cirrhosis, and also if it has potential beneficial effects in decreasing inflammation and improving analytical markers of progression of liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Phase II, multicenter, double-blind placebo controlled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Simvastatin 20 mg + Rifaximin 400 mg (group 1) | Experimental | Drug: Simvastatin 20 mg, Drug: Rifaximin 400 mgSimvastatin 20 mg/day and rifaximin 400 mg/8 hours orally for 12 weeks |
| Simvastatin 40 mg + Rifaximin 400 mg (group 2) | Experimental | Drug: Simvastatin 40mg, Drug: Rifaximin 400 mgSimvastatin 40 mg/day and rifaximin 400 mg/8 hours orally for 12 weeks |
| Placebo of Simvastatin + Placebo of Rifaximin (group 3) | Placebo comparator | Other: Placebo of Simvastatin, Other: Placebo of RifaximinPlacebo simvastatin and placebo rifaximin orally for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- Cirrhosis defined by standard clinical criteria and ultrasonographic findings and/or histology. Cirrhosis of any etiology may be included. Patients with cirrhosis of autoimmune etiology on treatment with corticosteroids must be on stable corticosteroid dose for ≥3-month period before study inclusion.
- Child Pugh B/C patients (from 7 to 12 points).
- Women of child-bearing potential must have a negative pregnancy test in urine before the inclusion of the study and agree to use highly effective contraceptive methods (combined oral pill, injectable or implanted contraceptive, intrauterine device / intrauterine hormone-releasing system) during the study.
Key exclusion criteria (27 listed)
- Patients on treatment with statins or rifaximin one month before study inclusion.
- Patients on the waiting list for liver transplantation.
- Patients with acute-on-chronic liver failure according to the criteria published by Moreau et al.
- Serum creatinine ≥2 mg/dL.
- Serum bilirubin>5 mg/dL.
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 |
|---|---|---|
| Simvastatin 20 mgSimvastatin 20 mg/day for 12 weeks (Group 1) | Drug | Simvastatin 20 mg + Rifaximin 400 mg (group 1) |
| Simvastatin 40mgSimvastatin 40 mg/day for 12 weeks (Group 2) | Drug | Simvastatin 40 mg + Rifaximin 400 mg (group 2) |
| Rifaximin 400 mgRifaximin 400 mg/8 hours for 12 weeks (Group 1 and 2) | Drug | Simvastatin 20 mg + Rifaximin 400 mg (group 1), Simvastatin 40 mg + Rifaximin 400 mg (group 2) |
| Placebo of SimvastatinPlacebo of Simvastatin for 12 weeks (Group 3) | Other | Placebo of Simvastatin + Placebo of Rifaximin (group 3) |
| Placebo of RifaximinPlacebo of Rifaximin for 12 weeks (Group 3) | Other | Placebo of Simvastatin + Placebo of Rifaximin (group 3) |
Primary outcome
Change from baseline in transaminases during the treatment period, to evaluate treatment-related toxicity.
Time frame: Week 12
This quantitative analysis will consist of liver toxicity assessed by the development of liver injury defined as 3-fold increase in serum transaminases to a final value at least 3 times the upper normal limit
Change from baseline in alkaline phosphatase during the treatment period, to evaluate treatment-related toxicity.
Time frame: Week 12
This quantitative analysis will consist of liver toxicity assessed by the development of liver injury defined as 2-fold increase in serum levels of alkaline phosphatase with respect to baseline value to a final value at least 2 times the upper normal limit
Change from baseline in creatine kinase during the treatment period, to evaluate treatment-related toxicity.
Time frame: Week 12
This quantitative analysis will consist of muscle toxicity defined as 5-fold increase in creatine kinase (CK) levels during treatment
27 secondary outcomes
Appearance of muscle toxicity at weeks 2, 4, 6, 8, 10 and 12 as defined using a specific statin-associated myopathy questionnaire
Time frame: Weeks 2, 4, 6, 8, 10 and 12
Changes from baseline in plasma renin concentration levels at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in serum aldosterone levels at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in plasma norepinephrine levels at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in plasma copeptin levels at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, VCAM-1 and ICAM-1
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, VEGF-A
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, Fractalkine
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, MIP-1α
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, Eotaxin
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, IP-10
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, RANTES
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, GM-CSF
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, IL-1β, IL-2, IL-6 and IL-8
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, MCP-1
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, oxidized form of albumin
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline of plasma cytokine levels including, but not limited to, HNA2
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in plasma biomarker FABP4 at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in plasma biomarker CD-163 at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker NGAL at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker IL-18 at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker MCP-1 at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker osteopontin at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes from baseline in urine biomarker albumin at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Changes in blood levels of bacterial DNA or bacterial products at weeks 2, 4, 8 and 12.
Time frame: Weeks 2, 4, 8 and 12
Number of patients with genetic polymorphisms of statins membrane transporter OATPB1 in patients developing treatment-related toxicity (defined as the primary endpoint of the study).
Time frame: Week 12
Proportion of patients with treatment-related serious adverse events during the study period.
Time frame: Week 12
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 28 Mar 2019.
- Derived from this study: PubMed 31607677Pose E, Napoleone L, Amin A, Campion D, Jimenez C, Piano S, Roux O, Uschner FE, de Wit K, Zaccherini G, Alessandria C, Angeli P, Bernardi M, Beuers U, Caraceni P, Durand F, Mookerjee RP, Trebicka J, Vargas V, Andrade RJ, Carol M, Pich J, Ferrero J, Domenech G, Llopis M, Torres F, Kamath PS, Abraldes JG, Sola E, Gines P. Safety of two different doses of simvastatin plus rifaximin in decompensated cirrhosis (LIVERHOPE-SAFETY): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):31-41. doi: 10.1016/S2468-1253(19)30320-6. Epub 2019 Oct 10.
- 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.
Pere Ginès, MD study chair
Hospital Clinic of Barcelona
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin 20 mg, Simvastatin 40mg and Rifaximin 400 mg in people with Cirrhoses, Liver, run by Judit Pich at 9 sites in 6 countries.
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 27 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Spain, France, Germany, Netherlands and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in transaminases during the treatment period, to evaluate treatment-related toxicity. (time frame: Week 12). The study lists 3 primary outcomes in all. 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 NCT03150459, which also lists 1 linked publication.
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 28 Mar 2019.