Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT02787304
Last Updated: 2019-11-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
197 participants
INTERVENTIONAL
2016-10-24
2018-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SHP626 5 Milligram (mg)
Subject will be administered 5 mg SHP626 capsule by orally once daily in a double-blinded fashion
SHP626
5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion
SHP626 10 Milligram (mg)
Subject will be administered 10 mg SHP626 capsule by orally once daily in a double-blinded fashion
SHP626
5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion
SHP626 20 Milligram (mg)
Subject will be administered 20 mg SHP626 capsule by orally once daily in a double-blinded fashion
SHP626
5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion
Placebo (PBO)
Subject will be administered SHP626 matching PBO capsule by orally once daily in a double-blinded fashion
Placebo
Matching placebo
Interventions
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SHP626
5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion
Placebo
Matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative, as applicable) informed consent to participate in the study.
3. Age 18-80 years inclusive. This inclusion criterion will only be assessed at the first screening visit.
4. Male, or non-pregnant, non-lactating female, who is sexually active and who agrees to comply with the contraceptive requirements of the protocol, or females of non-childbearing potential. Males and females of child-bearing potential who are sexually active must agree to use acceptable contraception during the study and for 30 days following the last dose of the investigational product (IP).
5. Presence of greater than equals to (\>=) 5 percent (%) steatosis on screening magnetic resonance imaging (MRI) from a centrally read radiologist performed either during the screening period or within 6 months prior to the first visit.
6. Histologic confirmation of nonalcoholic steatohepatitis (NASH) without cirrhosis (F0-F3) from a centrally read liver biopsy performed either during the screening period or within 6 months prior to the first visit with a NAS of \>=4 with a score of at least 1 in each component (steatosis, lobular inflammation, and hepatocyte ballooning).
Exclusion Criteria
2. History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings including, but not limited to: active hepatitis B virus (HBV) infection (hepatitis B surface antigen \[HBsAg\] positive and/or hepatitis B virus deoxyribonucleic acid (HBVDNA) positive; subjects who are hepatitis B core antibody \[HBcAb\] positive may be eligible as long as HBsAg is negative and HBVDNA is non detectable), active hepatitis C virus (HCV) infection (prior exposure to HCV \[defined as HCVAb positive\] without a current or prior history of a detectable HCVRNA) may be eligible, alcoholic liver disease, proven autoimmune hepatitis, primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, bile duct obstruction, liver primary or metastatic cancer.
3. Current or recurrent disease that could affect the action, absorption, disposition, or laboratory assessment of the IP (including bile salt metabolism in the intestine) example (e.g,) uncontrolled inflammatory bowel disease, uncontrolled celiac disease, gastric bypass procedures (gastric lap band or gastric sleeve is acceptable), ileal or ileocecal resection, uncontrolled irritable bowel syndrome with predominant diarrhea, or history of chronic diarrhea or loose stools of any etiology.
4. Weight change \>=5% after qualifying liver biopsy and/or MRI performed. If the subject had a liver biopsy and/or MRI within 6 months of screening, but experienced a weight change of \>=5% since the date of liver biopsy and/or MRI, the liver biopsy and/or MRI must be repeated at screening.
5. Contraindications to MRI (e.g, claustrophobia, coronary stents, coronary implantable devices, girth, etc.). Stents or other devices may be allowed, at the investigator's discretion, if they do not interfere with the functioning of the MRI machine.
6. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to complete the study.
7. Treatment with Vitamin E, thiazolidinediones (TZD), or glucagon-like peptide-1 receptor agonists (GLP-1 RA) unless subject on a stable dose for 6 months prior to qualifying liver biopsy and not initiated after qualifying liver biopsy and will continue the same dosing regimen throughout study participation.
8. Uncontrolled diabetes defined as HbA1c of \>=9.5% within 60 days prior to enrollment.
9. Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect the action, absorption, or disposition of the IP, or clinical or laboratory assessment. (Current use is defined as use within 14 days of screening). Subjects currently taking insulin will not be excluded; however, they must be on a stable dose for at least 30 days prior to screening, or a sliding scale of insulin is allowed as long as the subject's HbA1c remains less than (\<) 9.5%.
10. Use of drugs, herbs or supplements historically associated with causing or worsening NAFLD/NASH for less than 6 months prior to liver biopsy, or initiated any time after liver biopsy performed, including the use of total parenteral nutrition (TPN).
11. Serum aspartate aminotransferase (AST) greater than (\>) 7 times upper limit of normal (ULN) at screening.
12. Serum alanine aminotransferase (ALT) \>7 times ULN at screening.
13. Elevated serum creatinine \>=2.0 milligram/deciliter (mg/dL).
14. International normalized ratio (INR) \>1.3
15. Total bilirubin (TB) \>2.0 times ULN at screening (Except for documented Gilbert's syndrome with bilirubin levels 20 micromole per liter (mcmol/L) to 90 mcmol/L (1.2 to 5.3 mg/dL) and with a ratio of unconjugated/conjugated bilirubin that is commensurately higher).
16. Platelet count \<130 × 10\^9/liter (L)
17. Medical history of impaired hemostasis or use of anticoagulant medication (use of antiplatelet medications, such as low-dose, that is 81 mg, aspirin \[ASA\] or clopidogrel \[Plavix\] will be allowed).
18. Uncontrolled thyroid disease.
19. Type 1 diabetes mellitus.
20. Known or suspected intolerance or hypersensitivity to the IP, closely-related compounds, or any of the stated ingredients.
21. Known history of alcohol or other substance abuse within the last year or at any time during the study based on investigator's discretion. Weekly alcohol intake greater than 21 grams/day for males and 14 grams/day for females on average or inability to reliably quantify alcohol consumption based on investigator's judgment.
22. Within 6 months of MRI and liver biopsy:
* Have used any IP.
* Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
23. Inability to safely obtain a liver biopsy.
24. Females who are pregnant, planning to become pregnant, or are breastfeeding, or males who are planning to father a child during study participation.
25. The anticipated need for a surgical procedure during the study that could interfere with the treatment.
26. Known positivity for human immunodeficiency virus (HIV) infection.
27. Cancer within 5 years of screening, except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma that has been treated with no evidence of recurrence.
28. History of noncompliance with medical regimens, unreliability, mental instability or incompetence that could compromise the validity of informed consent or lead to noncompliance with the study protocol.
29. Any other conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the subject, or interfere with the subject participating.
30. Subject is currently enrolled in this study at any study site (unless the subject is transferring to another qualified study site with prior sponsor approval).
31. Subjects who are employees at the unit of the investigational site that is conducting the study.
18 Years
80 Years
ALL
No
Sponsors
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Mirum Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Mirum
Locations
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Southern California Research Center
Coronado, California, United States
Fresno Clinical Research Center
Fresno, California, United States
Ceders-Sinai Medical Center
Los Angeles, California, United States
California Liver Research Institute
Pasadena, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
South Denver Gastroenterology, PC
Englewood, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
George Washington (GW) Medical Faculty Associates
Washington D.C., District of Columbia, United States
Schiff Center for Liver Diseases
Miami, Florida, United States
South Florida Center of Gastroenterology
Wellington, Florida, United States
Internal Medicine Associates of Wellstar Atlanta Medical
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
The Queen's Medical Center - Liver Center
Honolulu, Hawaii, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Liver Research Center
Louisville, Kentucky, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates
Catonsville, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Henry Ford Health System
Novi, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Northwell Health Inc.
Manhasset, New York, United States
Concorde Medical Group PLLC
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Center for Liver Disease
Charlotte, North Carolina, United States
DUMC-Gastroenterology
Durham, North Carolina, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
Carolinas Center for Liver Disease
Statesville, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Clinsearch, LLC
Chattanooga, Tennessee, United States
University of TN Health Science Center
Memphis, Tennessee, United States
Quality Medical Research
Nashville, Tennessee, United States
Austin Center for Clinical Research
Austin, Texas, United States
Methodist Health Systems Clinical
Dallas, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
DHAT Research Institute
Richardson, Texas, United States
UVM Medical Center
Burlington, Vermont, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Bon Secours Liver Institute of Virginia
Richmond, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
UW Digestive Health Center (DHC)
Madison, Wisconsin, United States
University of Calgary Liver Unit
Calgary, Alberta, Canada
LAIR Centre
Vancouver, British Columbia, Canada
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, Canada
Nova Scotia Heath Authority
Halifax, Nova Scotia, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
CRCHUM
Montreal, Quebec, Canada
UPR: Medical Sciences Campus
San Juan, , Puerto Rico
Royal Free Hospital
Hampstead, London, United Kingdom
Norfolk & Norwich University Hospital
Norwich, Norfolk, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
NHS Tayside
Dundee, Tayside, United Kingdom
University Hospital Birmingham
Birmingham, West Midlands, United Kingdom
Royal London Hospital
London, , United Kingdom
Nottingham Digestive Diseases Centre and Biomedical Research Unit
Nottingham, , United Kingdom
Abertawe Bro Morgannwg University
Swansea, , United Kingdom
York Clinical Research Facility
York, , United Kingdom
Countries
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References
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Newsome PN, Palmer M, Freilich B, Sheikh MY, Sheikh A, Sarles H, Herring R, Mantry P, Kayali Z, Hassanein T, Lee HM, Aithal GP; Volixibat in Adults study group. Volixibat in adults with non-alcoholic steatohepatitis: 24-week interim analysis from a randomized, phase II study. J Hepatol. 2020 Aug;73(2):231-240. doi: 10.1016/j.jhep.2020.03.024. Epub 2020 Mar 29.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2016-000203-82
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHP626-201
Identifier Type: -
Identifier Source: org_study_id
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