Indianapolis, INNCT04250259Now EnrollingIRB Ready

Alcoholic Cirrhosis Clinical Trial in Indianapolis, IN

Access cutting-edge alcoholic cirrhosis treatment through this phase 2 clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by Indiana University

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Expert Care in Indianapolis

Access alcoholic cirrhosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related alcoholic cirrhosis treatment provided free

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Check if you qualify for this alcoholic cirrhosis clinical trial in Indianapolis, IN

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Alcoholic Cirrhosis Study in Indianapolis

The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortalit

Sponsor: Indiana University

Who Can Participate

Inclusion Criteria

for patients with alcoholic cirrhosis
Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and/or histopathology by biopsy and
subjects with clinical presentation either in Child Class A or B at the time of enrollment
individuals 18 to 70 years old and may or may not consume alcohol during study. Inclusion criteria for healthy control : ) individuals 18 to 70 years old (2) able to provide informed consent (3) subjects do not consume any alcohol or those who drink \< 50 grams per day on average in women and \< 80 grams per day on average in men (4) subjects are healthy without underlying acute or chronic medical conditions.

Exclusion Criteria

for patients with alcoholic cirrhosis
Active infection as evidenced by positive urine culture, blood culture, or pneumonia,
Known co-existing infection with hepatitis C, hepatitis B, or HIV
Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study
Gastrointestinal bleeding within the prior 28 days3
Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
Women who are pregnant, may become pregnant, or nursing
Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of SAMe such as those with gastric bypass surgery
Subjects with history of/diagnosis of hepatocellular carcinoma
Members from the same family of study participant. This is based on the recent paper on the non-random sampling in randomized controlled trials4. We acknowledge that if we assign family members to identical treatment, randomization would not be totally correct; but if properly randomized, there is a chance that the members of the family might mix the pills. To avoid this issue and maintain the integrity of randomized blinded fashion, we will not include members from the same family into the study
Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and
Subjects who are immunocompromised Exclusion criteria for all healthy control participants:
subjects with an active and serious medical disease
subjects with an infectious disease
consume any alcohol within 3 months before the study
subjects with localized or systemic infection

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Indianapolis?

Yes, this clinical trial (NCT04250259) has an active research site in Indianapolis, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Alcoholic Cirrhosis Treatment Options in Indianapolis, IN

If you're searching for alcoholic cirrhosis treatment options in Indianapolis, IN, this clinical trial (NCT04250259) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Indianapolis research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced alcoholic cirrhosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all alcoholic cirrhosis clinical trials near you to find additional studies recruiting in your area.

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