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HMG-CoA Reductase Inhibitor

Statin Therapy for Primary Sclerosing Cholangitis

Q: Are there any open vacancies available for participants in this research?

Per the clinicaltrials.gov page, this medical study is presently searching for participants and was initially shared on May 31st 2023 with its latest update being June 12th of the same year.

Q: Am I eligible to join this investigation?

Eligibility for this medical trial is determined by the presence of inflammatory bowel disease and age within an 18-80 year old bracket. So far, 15 individuals have signed up to take part in the study.

Q: Does the study include geriatric participants?

This clinical trial has defined age boundaries of 18 and 80 years old as eligibility criteria.

Q: How extensive is the participant population for this research project?

Affirmative. As indicated by information published on clinicaltrials.gov, the trial is presently recruiting and was first posted on May 31st 2023 with a subsequent update occurring June 12th of that same year. Fifteen participants are needed from one location for this study to be successful.

Phase < 1

Recruiting

Led By Chiraag Kulkarni, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, week 14

Awards & highlights

Study Summary

This trial will study the effects of statin therapy in people with PSC, a liver disease with no cure that increases the risk of cancer/infection & may require a transplant.

Who is the study for?

This trial is for adults over 18 with Primary Sclerosing Cholangitis (PSC) and Inflammatory Bowel Disease. Participants must not be pregnant, have PSC-autoimmune hepatitis overlap, secondary sclerosing cholangitis conditions, serious medical issues without physician approval, or a history of statin use or allergy to it. They should also meet certain blood test criteria and not be on specific medications.Check my eligibility

What is being tested?

The study tests the effects of Rosuvastatin, a cholesterol-lowering drug (statin), in patients with PSC. It aims to understand how this treatment might help manage PSC by monitoring changes through various health markers collected from participants.See study design

What are the potential side effects?

While the side effects are not explicitly listed here, common side effects of statins like Rosuvastatin include muscle pain or weakness, headache, difficulty sleeping, flushing of the skin, nausea or dizziness. More serious but rare side effects can involve liver damage and increased blood sugar levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, week 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4, week 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in bacterial gene expression profile in the small intestine

Change in bile acid (BA) profile: conjugated:unconjugated BAs ratio

Change in bile acid (BA) profile: secondary bile acids:primary bile acids ratio

+2 more

Side effects data

From 2018 Phase 4 trial • 12 Patients • NCT03074630

genital fungal infection

100%

80%

60%

40%

20%

Study treatment Arm

Adverse Events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Rosuvastatin therapyExperimental Treatment1 Intervention

Participants will receive rosuvastatin for 12 weeks followed by a 2 week washout period prior to the final follow-up visit. All patients will receive the study drug, and will serve as their own control. No participants will receive placebo. Rosuvastatin is FDA approved for treatment of high cholesterol, but its use in this trial is off label.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rosuvastatin

2019

Completed Phase 4

~3150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,335 Total Patients Enrolled

Chiraag Kulkarni, MDPrincipal InvestigatorStanford University

Sidhartha Sinha, MDPrincipal InvestigatorStanford University

4 Previous Clinical Trials

190 Total Patients Enrolled

Media Library

Rosuvastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05912387 — Phase < 1

Primary Sclerosing Cholangitis Research Study Groups: Rosuvastatin therapy

Primary Sclerosing Cholangitis Clinical Trial 2023: Rosuvastatin Highlights & Side Effects. Trial Name: NCT05912387 — Phase < 1

Rosuvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05912387 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open vacancies available for participants in this research?

"Per the clinicaltrials.gov page, this medical study is presently searching for participants and was initially shared on May 31st 2023 with its latest update being June 12th of the same year."

Answered by AI

Am I eligible to join this investigation?

"Eligibility for this medical trial is determined by the presence of inflammatory bowel disease and age within an 18-80 year old bracket. So far, 15 individuals have signed up to take part in the study."

Answered by AI

Does the study include geriatric participants?

"This clinical trial has defined age boundaries of 18 and 80 years old as eligibility criteria."

Answered by AI

How extensive is the participant population for this research project?

"Affirmative. As indicated by information published on clinicaltrials.gov, the trial is presently recruiting and was first posted on May 31st 2023 with a subsequent update occurring June 12th of that same year. Fifteen participants are needed from one location for this study to be successful."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study

Sidhartha Ranjit Sinha 2023. "Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05912387.

All > Inflammatory Bowel Disease