Alcoholic HepatitisPhase 2AHNCT01912404
Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy
A Phase 2 study testing IDN-6556 in people with Alcoholic Hepatitis, run by Conatus Pharmaceuticals Inc. at 3 sites in United States.
Trial summary
The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- IDN-6556
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2013to Aug 2015
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent (either from patient or patient's legally acceptable representative), and understand and willing to comply with the requirements of the study
- Male or female patients 21 years of age or older
- Patients with alcoholic hepatitis defined as:
- History of heavy alcohol abuse use: >40 g/day in females and >60 g/day in males for most days in a minimum period of 6 months
- Consumed alcohol within 6 weeks of entry into the study
- Biochemical parameters of severe disease as evidenced by MELD score >20 but <35, or MELD score 35-40 if the SOFA score is <10
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- Willingness to utilize 2 reliable forms of contraception (for both males and females of childbearing potential) from screening to 1 month after the completion of study treatment
- Patients with established contraindications to steroid use including but not limited to the following:
- GI bleed
- Active infection, including spontaneous bacterial peritonitis, based on positive blood culture, urine culture, or chest x-ray (if positive, must have been on antibiotics for at least 24 hours prior to study entry)
- Acute pancreatitis (increased lipase > 3x ULN or radiologic evidence)
- Positivity for hepatitis B (HBsAg+) or C virus (HCV+), and
- Renal failure
Who cannot join
- Other or concomitant cause of liver disease as a result of:
- Autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer >1:160)
- Metabolic liver disease (abnormal ceruloplasmin levels)
- Vascular liver disease
- Drug induced liver disease Note: Concurrent viral hepatitis is not excluded.
- Co-infection with human immunodeficiency virus (HIV)
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- Sepsis as evidenced by positive blood or urine culture, or pneumonia as confirmed by x-ray
- History of renal transplant and/or on dialysis at time of entry into study
- Inflammatory bowel disease
- Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
- Hepatocellular carcinoma (HCC) at entry into the study
- Active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
- Active tuberculosis on chest x-ray at study entry
- History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec)
- Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the patient from participating in and completing the study
- Patients requiring the use of vasopressors or inotropic support
- Liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis
- Any patient that has received any investigational drug or device within 30 days of dosing or who is scheduled to receive another investigational drug or device in the course of the study Note: Investigational drug includes any drug that is used off-label.
- If female, known pregnancy, or has a positive urine or serum pregnancy test, or lactating/breastfeeding
- If male, if partner is known to be pregnant at time of entry into study or becomes pregnant while patient is on study drug or up to 1 month after completion of study drug
- Appropriate candidate for corticosteroid therapy
- Treatment for alcohol hepatitis within 1 month of study entry with use of corticosteroids for >1 week or corticosteroid use at the time of entry into the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University
Indianapolis, Indiana, 46202
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Corticosteroid Therapy
The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.
Read the detailed description
The study will also see if overall patient survival is affected at 6 months, and if the study drug improves liver function.
- Conditions
- Alcoholic Hepatitis
- Being tested
- IDN-6556, Placebo
- Keywords
- alcoholic hepatitis
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDN-6556Drug
Also called emricasan, PF-03491390
25 mg BID for 28 days
PlaceboDrug
Placebo controlled
| Study group | Role | What they receive |
|---|---|---|
| IDN-6556 | Experimental | IDN-6556 capsules, 25 mg BID Receives: Drug: IDN-6556 |
| Placebo | Placebo comparator | Placebo capsules BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Due to concern for high systemic drug levels that could exceed levels in toxicology studies.
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 Alcoholic HepatitisStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- David Hagerty, MD, Study director, Conatus Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912404
- Sponsor's protocol ID
- IDN-6556-04
- Other IDs
- 5U01AA021788
- Acronym
- AH
- Status last verified
- Sep 2016
- First submitted
- 29 Jul 2013
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Study was terminated early with insufficient subjects for meaningful analysis.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Corticosteroid Therapy
- ClinicalTrials.gov ID
- NCT01912404
- Acronym / sponsor ID
- AH / IDN-6556-04
- Conditions
- Alcoholic Hepatitis
- Keywords
- alcoholic hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to concern for high systemic drug levels that could exceed levels in toxicology studies.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Conatus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Posted 4 Nov 2016
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 the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.
Detailed description
The study will also see if overall patient survival is affected at 6 months, and if the study drug improves liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDN-6556 | Experimental | Drug: IDN-6556IDN-6556 capsules, 25 mg BID |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules BID |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Able to provide written informed consent (either from patient or patient's legally acceptable representative), and understand and willing to comply with the requirements of the study
- Male or female patients 21 years of age or older
- Patients with alcoholic hepatitis defined as:
- Willingness to utilize 2 reliable forms of contraception (for both males and females of childbearing potential) from screening to 1 month after the completion of study treatment
- Patients with established contraindications to steroid use including but not limited to the following:
Key exclusion criteria (22 listed)
- Other or concomitant cause of liver disease as a result of:
- Co-infection with human immunodeficiency virus (HIV)
- Sepsis as evidenced by positive blood or urine culture, or pneumonia as confirmed by x-ray
- History of renal transplant and/or on dialysis at time of entry into study
- Inflammatory bowel disease
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 |
|---|---|---|
| IDN-6556Also: emricasan, PF-0349139025 mg BID for 28 days | Drug | IDN-6556 |
| PlaceboPlacebo controlled | Drug | Placebo |
Primary outcome
Survival
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Study was terminated early with insufficient subjects for meaningful analysis.
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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.
David Hagerty, MD study director
Conatus Pharmaceuticals Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IDN-6556 in people with Alcoholic Hepatitis, run by Conatus Pharmaceuticals Inc. at 3 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 13 inclusion and 22 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Yes. Results are posted in the registry (first posted 4 Nov 2016). 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?
Survival (time frame: 28 days). 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 4 Nov 2016.