Autoimmune HepatitisPhase 2NCT00608894
LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis
A Phase 2 study testing LCP-Tacro (tacrolimus) and Azathioprine in people with Autoimmune Hepatitis, run by Veloxis Pharmaceuticals at 12 sites in 2 countries.
Trial summary
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- LCP-Tacro (tacrolimus) and Azathioprine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Dec 2007to Jul 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women at least 18 years of age with a diagnosis of definite or probable AIH defined by the revised International Autoimmune Hepatitis Group (IAIHG) criteria
- Elevation of serum ALT ≥ 1.5 times the upper limit of normal
- Liver biopsy showing chronic hepatitis consistent with AIH
- Patients able to swallow the study medication
- Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study
- Women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication and agree to use contraceptive measures to avoid pregnancy during participation in the trial.
Who cannot join
- Patients with other concurrent liver disease
- Patients with cirrhosis on liver biopsy with a MELD score > 15
- Patients with a history or presence of decompensated liver disease
- Patients with serum creatinine ≥ 1.5 mg/dL prior to enrollment
- Patients positive for HCV RNA or Hepatitis B surface antigen (HBsAg)
- Patients with a history of alcohol intake > 25 g/day within the past six months
Show all 22Show fewer
- Patients with TSH outside normal range accompanied by an abnormal T4
- Patients with alpha-fetoprotein ≥ 20 ng/mL
- Patients with severe anemia (hemoglobin < 8 g/dL), leukopenia (WBC < 4000/mm3), or thrombocytopenia (platelet count < 100,000/mm3)
- Patients with a history of recent exposure to hepatotoxic drugs
- Patients who require therapy with any immunosuppressive agent other than those prescribed in the study
- Patients unable or unwilling to provide informed consent
- Pregnant or nursing women
- Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception
- Patients who have been treated with another investigational agent in the three months prior to enrollment
- Patients receiving any drug interfering with tacrolimus metabolism
- Patients with current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully
- Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
- Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- Patients with a known hypersensitivity to azathioprine, corticosteroids or tacrolimus
- Patients with any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator
- Patients who are recipients of an organ transplant or who require treatment with immunosuppressives or corticosteroids for any disease other than AIH.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States8 sites
Northwestern University
Chicago, Illinois, 60611
St. Luke's Advanced Liver Therapies
Houston, Texas, 77030
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32216
University of Minnesota
Minneapolis, Minnesota, 55455
Mount Sinai Medical Center
New York, New York, 10029
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Canada4 sites
Heritage Medical Research Clinic
Calgary, Alberta, T2N 4N1
Zeildler Ledcor Centre
Edmonton, Alberta, T6G 2X8
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
John Buhler Research Centre, University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: A Phase II, Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro Tablets vs. Azathioprine, in Combination With Corticosteroids, for the Treatment of Autoimmune Hepatitis
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH).
Read the detailed description
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine for the treatment of autoimmune hepatitis (AIH).
Patients with histologically confirmed chronic hepatitis who fulfill criteria established by the International Autoimmune Hepatitis Group (IAIHG) and Inclusion and Exclusion criteria will be enrolled after having signed an informed consent document.
Up to 60 patients will be randomized (1:1) to receive treatment with LCP-Tacro + prednisone vs. azathioprine (AZA) + prednisone.
- LCP-Tacro will be started at 2 mg once daily (q.d.) with weekly measurement of tacrolimus whole blood trough levels and adjustment of the daily dose of LCP-Tacro to achieve target tacrolimus levels of 3 - 6 ng/mL. Patients with histological evidence of cirrhosis and a Model for End-Stage Liver Disease (MELD) score ≤ 8 will commence LCP-Tacro at a fixed dose of 1 mg once daily, with subsequent dosage adjustments to maintain tacrolimus trough levels at 3 - 6 ng/mL.
- AZA will be started at 50 - 100 mg (approximately 1 mg/kg) once daily (q.d.).
Patients will also commence treatment with prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
- Conditions
- Autoimmune Hepatitis
- Being tested
- LCP-Tacro (tacrolimus), Azathioprine
- Keywords
- Autoimmune hepatitis, Chronic active hepatitis
- Medical subject headings
- Hepatitis, Autoimmune, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCP-Tacro (tacrolimus)Drug
Also called 1,2,and 5mg tacrolimus tablets
LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
AzathioprineDrug
Also called 50mg azathioprine tablets + 5mg prednisone tablets
Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
| Study group | Role | What they receive |
|---|---|---|
| LCP-Tacro | Experimental | LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg) Receives: Drug: LCP-Tacro (tacrolimus) |
| Azathioprine | Active comparator | Azathioprine tablets(50mg)+ prednisone tablets(5mg) Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Remission of (AIH) at Month 6.
Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits.
Measured: 6 months
Secondary outcomes (2)
Biochemical Remission by Month 3.
Percent of patients who achieve biochemical remission by Month 3 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits.
Measured: 3 months
Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months
Percents of patients in each treatment group classified as having an incomplete response (defined as some or no improvement during therapy), a treatment failure (defined as permanent discontinuation of the regimen originally randomized to), or a case of relapse (recurrence following achievement of remission)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2009
- Study completionJul 2009
Why it stopped: Study was discontinued due to slow enrollment
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 Autoimmune 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
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veloxis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerald Y Minuk, M.D., Principal investigator, University of Manitoba Health Sciences Centre, WinnipegAndrew Mason, MD, Principal investigator, University of Alberta, EdmontonRussell H Wiesner, MD, Principal investigator, Mayo Clinic, Rochester, MNJohn M Vierling, MD, Principal investigator, Baylor College of MedicineVelimir A Luketic, MD, Principal investigator, Virginia Commonwealth University, Richmond, VAJoseph A Odin, MD, PhD, Principal investigator, Mount Sinai Medical Center, New York, NYElizabeth Carey, MD, Principal investigator, Mayo ClinicJohn R Lake, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608894
- Sponsor's protocol ID
- LCP-Tacro Study 2016
- Status last verified
- Mar 2020
- First submitted
- 23 Jan 2008
- Last updated
- 17 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro Tablets vs. Azathioprine, in Combination With Corticosteroids, for the Treatment of Autoimmune Hepatitis
- ClinicalTrials.gov ID
- NCT00608894
- Acronym / sponsor ID
- LCP-Tacro Study 2016
- Conditions
- Autoimmune Hepatitis
- Keywords
- Autoimmune hepatitis, Chronic active hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was discontinued due to slow enrollment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Veloxis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007 (actual)
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 6 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH).
Detailed description
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine for the treatment of autoimmune hepatitis (AIH).
Patients with histologically confirmed chronic hepatitis who fulfill criteria established by the International Autoimmune Hepatitis Group (IAIHG) and Inclusion and Exclusion criteria will be enrolled after having signed an informed consent document.
Up to 60 patients will be randomized (1:1) to receive treatment with LCP-Tacro + prednisone vs. azathioprine (AZA) + prednisone.
- LCP-Tacro will be started at 2 mg once daily (q.d.) with weekly measurement of tacrolimus whole blood trough levels and adjustment of the daily dose of LCP-Tacro to achieve target tacrolimus levels of 3 - 6 ng/mL. Patients with histological evidence of cirrhosis and a Model for End-Stage Liver Disease (MELD) score ≤ 8 will commence LCP-Tacro at a fixed dose of 1 mg once daily, with subsequent dosage adjustments to maintain tacrolimus trough levels at 3 - 6 ng/mL.
- AZA will be started at 50 - 100 mg (approximately 1 mg/kg) once daily (q.d.).
Patients will also commence treatment with prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCP-Tacro | Experimental | Drug: LCP-Tacro (tacrolimus)LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg) |
| Azathioprine | Active comparator | Drug: AzathioprineAzathioprine tablets(50mg)+ prednisone tablets(5mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women at least 18 years of age with a diagnosis of definite or probable AIH defined by the revised International Autoimmune Hepatitis Group (IAIHG) criteria
- Elevation of serum ALT ≥ 1.5 times the upper limit of normal
- Liver biopsy showing chronic hepatitis consistent with AIH
- Patients able to swallow the study medication
- Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study
Key exclusion criteria (22 listed)
- Patients with other concurrent liver disease
- Patients with cirrhosis on liver biopsy with a MELD score > 15
- Patients with a history or presence of decompensated liver disease
- Patients with serum creatinine ≥ 1.5 mg/dL prior to enrollment
- Patients positive for HCV RNA or Hepatitis B surface antigen (HBsAg)
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 |
|---|---|---|
| LCP-Tacro (tacrolimus)Also: 1,2,and 5mg tacrolimus tabletsLCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6. | Drug | LCP-Tacro |
| AzathioprineAlso: 50mg azathioprine tablets + 5mg prednisone tabletsAzathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6. | Drug | Azathioprine |
Primary outcome
Biochemical Remission of (AIH) at Month 6.
Time frame: 6 months
Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits.
2 secondary outcomes
Biochemical Remission by Month 3.
Time frame: 3 months
Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gerald Y Minuk, M.D. principal investigator
University of Manitoba Health Sciences Centre, Winnipeg
Andrew Mason, MD principal investigator
University of Alberta, Edmonton
Russell H Wiesner, MD principal investigator
Mayo Clinic, Rochester, MN
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LCP-Tacro (tacrolimus) and Azathioprine in people with Autoimmune Hepatitis, run by Veloxis Pharmaceuticals at 12 sites in 2 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 6 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. 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 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 6 Mar 2020). 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?
Biochemical Remission of (AIH) at Month 6. (time frame: 6 months). 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 17 Mar 2020.