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Saroglitazar Magnesium for Non-alcoholic Fatty Liver Disease in HIV (SARONAPLUS Trial)
SARONAPLUS Trial Summary
This trialstudies a drug to treat fatty liver in people living with HIV in the US.
SARONAPLUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSARONAPLUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SARONAPLUS Trial Design
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Who is running the clinical trial?
Media Library
- My liver biopsy confirms NASH with a NAS score of 4 or more.I am an adult with confirmed HIV.I haven't taken liver-affecting drugs or weight-changing hormones in the last 3 months.My diabetes is not under control, with an HbA1c level over 9.5%.I have been on a stable HIV treatment for at least 3 months and don't plan to change it.I have had a liver transplant.My tests show signs of cirrhosis or high blood pressure in the liver.I have a history of liver disease or hepatitis in the last 3 years.My HIV-1 levels have been under control for at least 6 months.I am not pregnant, breastfeeding, and I use effective birth control.
- Group 1: Saroglitazar Magnesium 4 mg
- Group 2: Placebo Arm
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What potential risks are posed by the utilization of Saroglitazar Magnesium 4 mg?
"Despite the lack of efficacy data, our experts at Power have judged Saroglitazar Magnesium 4 mg to be a safe medication with an assigned score of 2."
What is the current participant count of this investigation?
"This clinical trial is in need of 160 participants that meet the defined inclusion criteria. Patients can join from Zydus research site 5 located in La Jolla, CA or Zydus research site 6 based in San Francisco, IN."
Are there any vacancies available in this research endeavor?
"Affirmative. Evidence on clinicaltrials.gov shows that this research trial, which was initially listed in late September 2022, is actively enrolling participants at 8 different sites. 160 people are needed to complete the study."
How widespread is the implementation of this trial?
"This study is actively recruiting patients in 8 different sites, including Zydus research site 5 in La Jolla, Zydus research site 6 in San Francisco and Zydus research site 2 in Indianapolis. There are also other centres across the country offering this trial."
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