Trial record 1 of 10 for:
"Autoimmune hepatitis"
LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis
This study has been completed.
Sponsor:
Veloxis Pharmaceuticals
Information provided by:
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00608894
First received: January 23, 2008
Last updated: October 21, 2009
Last verified: October 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Autoimmune Hepatitis |
Drug: LCP-Tacro (tacrolimus) Drug: Azathioprine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Prednisone
Azathioprine
Azathioprine Sodium
Tacrolimus
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by Veloxis Pharmaceuticals:
Primary Outcome Measures:
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent of patients who achieve biochemical remission by Month 3 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Percents of patients in each treatment group classified as either in remission, having an incomplete response, a treatment failure, or a case of relapse. Each patient will be classified as being one of the four states at Month 6. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LCP-Tacro
LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg)
|
Drug: LCP-Tacro (tacrolimus)
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.
Other Name: 1,2,and 5mg tacrolimus tablets
|
|
Active Comparator: Azathioprine
Azathioprine tablets(50mg)+ prednisone tablets(5mg)
|
Drug: Azathioprine
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.
Other Name: 50mg azathioprine tablets + 5mg prednisone tablets
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608894
Locations
| United States, Arizona | |
| Mayo Clinic - Phoenix | |
| Phoenix, Arizona, United States, 85054 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32216 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| United States, Texas | |
| St. Luke's Advanced Liver Therapies | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| Canada, Alberta | |
| Heritage Medical Research Clinic | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Zeildler Ledcor Centre | |
| Edmonton, Alberta, Canada, T6G 2X8 | |
| Canada, Manitoba | |
| John Buhler Research Centre, University of Manitoba Health Sciences Centre | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
Sponsors and Collaborators
Veloxis Pharmaceuticals
Investigators
| Principal Investigator: | Gerald Y Minuk, M.D. | University of Manitoba Health Sciences Centre, Winnipeg |
| Principal Investigator: | Andrew Mason, MD | University of Alberta, Edmonton |
| Principal Investigator: | Russell H Wiesner, MD | Mayo Clinic - Rochester, MN |
| Principal Investigator: | John M Vierling, MD | Baylor College of Medicine |
| Principal Investigator: | Velimir A Luketic, MD | Virginia Commonwealth University, Richmond, VA |
| Principal Investigator: | Joseph A Odin, MD, PhD | Mount Sinai Medical Center, New York, NY |
| Principal Investigator: | Elizabeth Carey, MD | Mayo Clinic - Phoenix |
| Principal Investigator: | John R Lake, MD | University of Minnesota - Clinical and Translational Science Institute |
| Principal Investigator: | Barry G Rosser, MD | Mayo Clinic |
| Principal Investigator: | Steven L Flamm, MD | Northwestern University |
| Principal Investigator: | Kevork M Peltekian, MD | Queen Elizabeth II Health Sciences Centre |
| Principal Investigator: | Mark G Swain, MD | University of Calgary |
More Information
No publications provided
| Responsible Party: | H. Eugene Griffin, MS, DVM, LifeCycle Pharma A/S |
| ClinicalTrials.gov Identifier: | NCT00608894 History of Changes |
| Other Study ID Numbers: | LCP-Tacro Study 2016 |
| Study First Received: | January 23, 2008 |
| Last Updated: | October 21, 2009 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Veloxis Pharmaceuticals:
|
Autoimmune hepatitis Chronic active hepatitis |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Autoimmune Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepatitis, Chronic Autoimmune Diseases Immune System Diseases Azathioprine Tacrolimus |
Prednisone Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 22, 2013