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Trial record 32 of 194 for:    serum | Non-Alcoholic Steatohepatitis

A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes (NASH)

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ClinicalTrials.gov Identifier: NCT02769091
Recruitment Status : Withdrawn (Business decision)
First Posted : May 11, 2016
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
The purpose of this study is to assess the effect of TEV-45478, as compared with placebo, on liver health and liver fat content in patients with T2DM who also have Nonalcoholic Steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Type 2 Diabetes Mellitus Drug: TEV-45478 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-Week, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of 80 mg TEV-45478 Once Daily as Treatment in Adult Patients With Nonalcoholic Steatohepatitis (NASH) Who Also Have Type 2 Diabetes Mellitus - GN
Actual Study Start Date : September 30, 2016
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : February 28, 2018


Arm Intervention/treatment
Experimental: TEV-45478
80 mg (2x40mg) tablets once daily for up to 24 weeks
Drug: TEV-45478
80 mg (2x40mg) tablets once daily for up to 24 weeks

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo



Primary Outcome Measures :
  1. serum Alanine Transaminase (ALT) levels response, defined as ALT value within reference range of <35 IU/L for women and <40 IU/L for men [ Time Frame: Week 24 ]
  2. liver fat response, defined as a reduction of ≥6% at week 24 compared to screening by the MRI-Proton Density Fat Fraction (PDFF) [ Time Frame: Week 24 ]
  3. Percentage of Participants with Adverse Events [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. percent change from baseline in ALT [ Time Frame: Baseline, Week 24 ]
  2. percent change from baseline in ALT [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 (or early withdrawal) ]
  3. percent change from baseline in Aspartate Aminotransferase (AST) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 (or early withdrawal) ]
  4. change from baseline in AST [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 (or early withdrawal) ]
  5. change from baseline in ALT [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 (or early withdrawal) ]
  6. Change from baseline in glycosylated hemoglobin ((HbA1c) [ Time Frame: Baseline, Weeks 4, 12, and 24 (or early withdrawal) ]
  7. Change from baseline in liver fibrosis measured using transient elastography (with Fibroscan) [ Time Frame: Baseline, Week 24 (or early withdrawal) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is female or male and aged 18 to 65 years, inclusive with a history of Type 2 Diabetes Mellitus (T2DM) and on stable medication for diabetes or insulin or a combination thereof for at least 3 months prior to screening.
  • The patient has a NASH Activity Score (NAS) of ≥4, with or without evidence of fibrosis, with a score of at least 1 in steatosis and lobular inflammation the subcomponents of NAS and a hepatocyte ballooning score of at least 1 score based on historical histological evaluation of liver biopsy within 12 months prior to randomization.
  • The patient has a historical diagnosis of NASH, established no more than 12 months prior to randomization based on histology (liver biopsy).
  • The patient has an ALT level at screening between 45 and 105 IU/L, inclusive, for women and between 55 and 120 IU/L, inclusive for men, at one other occasion during the 24-weeks prior to screening.
  • The patient has an MRI determined liver fat fraction of equal to or higher than 6% at Screening

    • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The patient has a history of chronic liver disease other than NASH eg, chronic or acute hepatitis, autoimmune, viral (A, B, C), genetic hepatitis, drug induced hepatotoxicity, Wilson's disease, alcoholic liver diseases, or any other non-NASH active liver disease.
  • The patient has active cancer or a history of a malignant disease (except basal cell carcinoma of the skin) within 5 years prior to screening or any history of bladder cancer.
  • The patient had an unstable metabolic condition (ie, with a history of weight loss or weight gain of >5 kg within 24 weeks prior to screening)
  • The patient has a history of bariatric surgery within 5 years prior to screening.
  • The patient has received mercaptopurine or azathioprine previously within 1 year prior to screening
  • The patient has taken within 7 days prior to the first dose of study drug (or is anticipated to take during the study) anticholinergic or other drugs known to affect gastrointestinal (GI) motility, proton-pump inhibitors, or other drugs known to affect gastric acidity or use of allopurinol.
  • The patient has received oral antibiotics within the last 4 weeks prior to randomization (day 1).
  • The patient has received treatment within the last 30 days with any drugs known to induce or inhibit endogenous hepatic drug metabolism (eg, barbiturates, phenothiazines, cimetidine, carbamazepine) or anti-coagulant therapy (eg, heparin, warfarin, acenocoumarol).
  • The patient has Type 1 Diabetes Mellitus (T1DM) or poorly controlled T2DM
  • The patient has a body mass index (BMI) <25 kg/m2.
  • The patient has a history of diabetic gastroparesis or has had gastric bypass surgery within the last 5 years.
  • The patient has a history of pancreatitis.
  • The patient has a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection or toxic megacolon or inflammatory bowel disease (IBD)
  • The patient has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, unstable angina, myocardial infarction, transient ischemic events, or stroke within 24-weeks prior to screening.
  • The patient is classified as Class II-IV via New York Heart Association
  • The patient has a history of drug abuse (defined as illicit drug use) or a history of excessive alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day for women or 3 alcoholic drinks per day for men) within 1 year prior to the screening visit.

    • Additional criteria apply, please contact the investigator for more information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769091


Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02769091     History of Changes
Other Study ID Numbers: TV45478-IMM-20019
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Fatty Liver
Non-alcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases