LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis

NCT00608894 | Terminated Phase 2 Results

• 1 other identifier: LCP-Tacro Study 2016
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 12

Brief 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).

Conditions

Autoimmune Hepatitis

Keywords

Autoimmune hepatitis; Chronic active hepatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• Biochemical Remission by Month 3.

  3 months

• Incomplete Response, Treatment Failure, or a Case of Relapse at 6 Months

  6 months

Study Arms (2)

LCP-Tacro

EXPERIMENTAL

LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg)

Drug: LCP-Tacro (tacrolimus)

Azathioprine

ACTIVE COMPARATOR

Azathioprine tablets(50mg)+ prednisone tablets(5mg)

Drug: Azathioprine

Interventions

LCP-Tacro (tacrolimus) DRUG

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.

Also known as: 1,2,and 5mg tacrolimus tablets

LCP-Tacro

Azathioprine DRUG

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.

Also known as: 50mg azathioprine tablets + 5mg prednisone tablets

Azathioprine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Veloxis Pharmaceuticals: lead

Study Sites (12)

Mayo Clinic - Phoenix

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32216, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

St. Luke's Advanced Liver Therapies

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Heritage Medical Research Clinic

Calgary, Alberta, T2N 4N1, Canada

Location

Zeildler Ledcor Centre

Edmonton, Alberta, T6G 2X8, Canada

Location

John Buhler Research Centre, University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune; Hepatitis, Chronic

Interventions

Tacrolimus; Azathioprine; Prednisone

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The study was discontinued due to slow enrollment. Consequently, the number of patients enrolled in the study was too small to permit meaningful statistical analyses.

Results Point of Contact

• Title: Director, Regulatory Affairs
• Organization: Veloxis Pharmaceuticals, Inc.

bbu@veloxis.com

919-591-3090

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• John R Lake, MD

  University of Minnesota

  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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: December 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 17, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-03

Locations

CA (4); US (8)