Hepatic InsufficiencyNCT04147936
Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency
A study testing AXA1665 in people with Hepatic Insufficiency, run by Axcella Health, Inc at 11 sites in United States.
Trial summary
This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- AXA1665
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 11 sitesUnited States
- Study dates
- 30 Mar 2019to 24 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate in the study and provide written informed consent
- Male and female adults aged > 18 years
- Child-Pugh score ≤9 (i.e. Child-Pugh class A or B)
- Liver Frailty Index (LFI) of ≥3.6
- Willing and able to engage in 30 minutes of walking/physical activity at least 3 days per week
Who cannot join
- Hospitalization for any complication of cirrhosis or taking new medications intended to treat hepatic encephalopathy within 2 months prior to Screening or any hospitalization for any cause/reason within 30 days prior to Screening
- Prior history or presence of a transjugular intrahepatic portal systemic shunt (TIPS)
- Current or history of significant alcohol consumption
- Other poorly controlled medical condition [e.g., renal disease with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2)
- Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.)
- Any extreme or unbalanced diet such as Ketogenic, Atkins, Paleo, Vegan, etc.
Show all 9Show fewer
- Unable or unwilling to adhere to contraception requirements
- Any contraindications to a MRI scan
- Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Delta Research Partners
Bastrop, Louisiana, 71220
Indiana University Health
Indianapolis, Indiana, 46202
Panax Clinical Research
Miami Lakes, Florida, 33014
Catalina Research Institute, LLC
Montclair, California, 91762
OMEGA Research Maitland, LCC
Orlando, Florida, 32810
UPMC Center for Liver Disease
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University
Richmond, Virginia, 23298
Texas Liver Institute
San Antonio, Texas, 78215
Avita Clinical Research
Tampa, Florida, 33613
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A 12-Week, Single-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety, Tolerability, and Physiological Regulation of an Amino Acid Food Product, AXA1665, in Subjects With Mild and Moderate Hepatic Insufficiency
This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.
- Conditions
- Hepatic Insufficiency
- Being tested
- AXA1665, Placebo
- Keywords
- Amino acids, food study
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXA1665Dietary supplement
Dietary supplement: AXA1665
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AXA1665 29.4g | Active comparator | Dietary Supplement: AXA1665 Amino acids, food study Receives: Dietary Supplement: AXA1665 |
| AXA1665 53.9 g | Active comparator | Dietary Supplement: AXA1665 Amino acids, food study Receives: Dietary Supplement: AXA1665 |
| Placebo 29.4 g | Placebo comparator | Dietary Supplement: Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline to Week 12
Secondary outcomes (9)
Change in muscle mass by MRI
Measured: Baseline to Week 12
Change in Fischer's ratio [measured by ratio of branched-chain amino acids (leucine, valine, isoleucine) to aromatic amino acids (phenylalanine, tyrosine)]
Measured: Baseline to Week 12
Change in plasma ammonia
Measured: Baseline to Week 12
Change in blood urea nitrogen concentration
Measured: Baseline to Week 12
Change in creatinine concentration
Measured: Baseline to Week 12
Change in gait speed
Measured: Baseline to Week 12
Change in Liver Frailty Index
Measured: Baseline to Week 12
Change in overall physical activity (measured by actigraphy watch)
Measured: Baseline to Week 12
Change in cognitive function measured by the Psychometric Hepatic Encephalopathy Score (PHES)
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start30 Mar 2019
- Primary completion20 May 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axcella Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arun J Sanyal, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147936
- Sponsor's protocol ID
- AXA1665-002
- Status last verified
- Sep 2020
- First submitted
- 21 Oct 2019
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Single-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety, Tolerability, and Physiological Regulation of an Amino Acid Food Product, AXA1665, in Subjects With Mild and Moderate Hepatic Insufficiency
- ClinicalTrials.gov ID
- NCT04147936
- Acronym / sponsor ID
- AXA1665-002
- Conditions
- Hepatic Insufficiency
- Keywords
- Amino acids, food study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Axcella Health, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 1 Nov 2019 (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.
This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AXA1665 29.4g | Active comparator | Dietary Supplement: AXA1665Dietary Supplement: AXA1665 Amino acids, food study |
| AXA1665 53.9 g | Active comparator | Dietary Supplement: AXA1665Dietary Supplement: AXA1665 Amino acids, food study |
| Placebo 29.4 g | Placebo comparator | Dietary Supplement: PlaceboDietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to participate in the study and provide written informed consent
- Male and female adults aged > 18 years
- Child-Pugh score ≤9 (i.e. Child-Pugh class A or B)
- Liver Frailty Index (LFI) of ≥3.6
- Willing and able to engage in 30 minutes of walking/physical activity at least 3 days per week
Key exclusion criteria (9 listed)
- Hospitalization for any complication of cirrhosis or taking new medications intended to treat hepatic encephalopathy within 2 months prior to Screening or any hospitalization for any cause/reason within 30 days prior to Screening
- Prior history or presence of a transjugular intrahepatic portal systemic shunt (TIPS)
- Current or history of significant alcohol consumption
- Other poorly controlled medical condition [e.g., renal disease with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2)
- Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.)
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 |
|---|---|---|
| AXA1665Dietary supplement: AXA1665 | Dietary supplement | AXA1665 29.4g, AXA1665 53.9 g |
| PlaceboPlacebo | Dietary supplement | Placebo 29.4 g |
Primary outcome
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline to Week 12
9 secondary outcomes
Change in muscle mass by MRI
Time frame: Baseline to Week 12
Change in Fischer's ratio [measured by ratio of branched-chain amino acids (leucine, valine, isoleucine) to aromatic amino acids (phenylalanine, tyrosine)]
Time frame: Baseline to Week 12
Change in plasma ammonia
Time frame: Baseline to Week 12
Change in blood urea nitrogen concentration
Time frame: Baseline to Week 12
Change in creatinine concentration
Time frame: Baseline to Week 12
Change in gait speed
Time frame: Baseline to Week 12
Change in Liver Frailty Index
Time frame: Baseline to Week 12
Change in overall physical activity (measured by actigraphy watch)
Time frame: Baseline to Week 12
Change in cognitive function measured by the Psychometric Hepatic Encephalopathy Score (PHES)
Time frame: Baseline to 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 18 Sep 2020.
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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.
Arun J Sanyal, MD principal investigator
Virginia Commonwealth University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AXA1665 in people with Hepatic Insufficiency, run by Axcella Health, Inc at 11 sites 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 5 inclusion and 9 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. 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.
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 study product emergent adverse events (AEs) and serious adverse events (SAEs) (time frame: Baseline to Week 12). 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 18 Sep 2020.