Severe Hepatic ImpairmentPhase 4NCT03818672
Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
A Phase 4 study testing Rifaximin in people with Severe Hepatic Impairment, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to characterize the steady state plasma Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Hepatic Impairment
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 2 Feb 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically impaired subjects will have a MELD score of >25.
Who cannot join
- Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients and/or vehicles used in the formulation, or any other clinically significant allergies.
- Subject has participated in an investigational drug or device study within 30 days prior to Day 1 (Baseline).
- Subject has any concurrent illness (other than liver cirrhosis), disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Study to Evaluate the Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy Subjects and Subjects With Severe Hepatic Impairment
The primary objective of this study is to characterize the steady state plasma
Read the detailed description
The primary objective of this study is to characterize the steady state plasma PK of rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD >25), as well as healthy subjects with normal hepatic function.
- Conditions
- Severe Hepatic Impairment
- Being tested
- Rifaximin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Rifaximin 550 MG BID
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Rifaximin 550 mg BID Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Measured: 7 days
Time of the Maximum Concentration (Tmax)
Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Measured: 7 days
Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval
Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start29 Jan 2019
- Primary completion2 Feb 2020
- Study completion2 Feb 2020
Why it stopped: Study determined to be infeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Varsha Bhatt, Study director, Bausch Health Companies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818672
- Sponsor's protocol ID
- RFPK4045
- Status last verified
- Nov 2023
- First submitted
- 22 Jan 2019
- Last updated
- 30 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Evaluate the Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy Subjects and Subjects With Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT03818672
- Acronym / sponsor ID
- RFPK4045
- Conditions
- Severe Hepatic Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study determined to be infeasible.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 30 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to characterize the steady state plasma
Detailed description
The primary objective of this study is to characterize the steady state plasma PK of rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD >25), as well as healthy subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: RifaximinRifaximin 550 mg BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically impaired subjects will have a MELD score of >25.
Key exclusion criteria (3 listed)
- Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients and/or vehicles used in the formulation, or any other clinically significant allergies.
- Subject has participated in an investigational drug or device study within 30 days prior to Day 1 (Baseline).
- Subject has any concurrent illness (other than liver cirrhosis), disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the investigator.
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 |
|---|---|---|
| RifaximinRifaximin 550 MG BID | Drug | Rifaximin |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 7 days
Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Time of the Maximum Concentration (Tmax)
Time frame: 7 days
Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable
Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval
Time frame: 7 days
Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Varsha Bhatt study director
Bausch Health Companies
1 site 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 in people with Severe Hepatic Impairment, run by Bausch Health Americas, Inc. at 1 site in United States.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 Nov 2023. 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 United States. 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.
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?
Yes. Results are posted in the registry (first posted 30 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Observed Plasma Concentration (Cmax) (time frame: 7 days). 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?
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 30 Nov 2023.