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HMG-CoA Reductase Inhibitor

1 for Crohn's Disease

N/A
Waitlist Available
Led By Brian Behm, MD
Research Sponsored by University of Virginia
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 up to 5 years
Awards & highlights

Summary

The primary objective of this study is to provide data regarding clinical and immunologic activity of oral doses of pravastatin 80mg administered daily for 6 consecutive weeks, for the treatment of active Crohn's disease as shown by the Harvey-Bradshaw Index (HBI) and/or elevated C-reactive protein (CRP). We hypothesize pravastatin will significantly reduce symptoms of Crohn's disease, as shown by a decrease in HBI, by the end of the study period. Secondary outcomes of this study include the effect of pravastatin on C-reactive protein, ESR, proinflammatory cytokines, and fecal lactoferrin.

Eligible Conditions
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2013 Phase 4 trial • 252 Patients • NCT01301066
2%
Headache
2%
Upper abdominal pain
2%
Blood CK increased
2%
Diarrhoea
2%
Fatigue
1%
Enterovesical fistula
1%
Diverticulitis
1%
Atrial septal defect
1%
Transient ischaemic attack
1%
Multiple fractures
1%
Respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Chest pain
1%
Gastroenteritis
1%
Gastroenteritis viral
1%
Herpes dermatitis
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pitavastatin 4 mg QD
Pravastatin 40 mg QD

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Patients with active Crohn's Disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pravastatin
FDA approved

Find a Location

Who is running the clinical trial?

American College of GastroenterologyOTHER
37 Previous Clinical Trials
6,910 Total Patients Enrolled
University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,257 Total Patients Enrolled
Brian Behm, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
10 Total Patients Enrolled
~2 spots leftby Sep 2025
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