Spironolactone Therapy In Young Women With NASH
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The following treatment regimens will be used: Experimental treatment - spironolactone, 100 mg once daily Placebo or Comparator - one capsule, once daily Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Due to the objectives of the study, the identity of test and control treatments will not be known to investigators, research staff, or patients. The following study procedures will be in place to ensure double-blind administration of study treatments Access to the randomization code will be strictly controlled. A color and size-matched placebo capsule that looks identical to the spironolactone capsule will be used. Packaging and labeling of test and control treatments will be identical to maintain the blind. The study blind will be broken on completion of the clinical study, after all study endpoints have been ascertained by blinded study coordinators and after the study database has been locked. During the study, the blind may be broken only in emergencies when knowledge of the patient's treatment group is necessary for further patient management. The UCSF investigational pharmacy would then be notified and responsible for unblinding.Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only males
Description
This is a single center, double-blind, placebo-controlled, randomized, (2:1) parallel group pilot clinical trial of spironolactone in women with biopsy-proven NASH receiving 6 or 12 months of spironolactone or placebo. 30 women are targeted for enrollment. Each participant will be administered a sin...
This is a single center, double-blind, placebo-controlled, randomized, (2:1) parallel group pilot clinical trial of spironolactone in women with biopsy-proven NASH receiving 6 or 12 months of spironolactone or placebo. 30 women are targeted for enrollment. Each participant will be administered a single dose of spironolactone or placebo once daily for a total of 6 or 12 months. In person evaluations will take place at Month 1, 3, 6, 9, and 12. There will be a telephone follow up visit within 3 months of end of treatment (up to Month 9 or 15). This is a pilot clinical trial that is largely feasibility focused. Study outcomes will include Change in liver stiffness on Magnetic Resonance Elastography (MRE) Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF) Change in visceral adipose tissue (VAT) volume by Magnetic Resonance Imaging (MRI) Change in NASH histology as assessed by the continuous NAFLD activity score (NAS), which measures different components of NASH on liver biopsy. Biochemical endpoints: serum lipids & HOMA-IR Feasibility outcomes including Rates (and reasons) for the following: a) % women that decline/women contacted for study inclusion (i.e. need for a second liver biopsy, concern regarding randomization to placebo) b) % women enrolled/women screened (i.e. exclusion criteria too narrow), c) study dropout (i.e. medication side effects, too frequent study visits, and/or phlebotomy)
Tracking Information
- NCT #
- NCT03576755
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Monika A Sarkar University of California, San Francisco
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