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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
Males and non-pregnant females on an adequate contraceptive regimen aged 18-65
Active Crohn's disease (HBI >5 or serum CRP concentration above the upper limits of normal on initial labs.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study 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
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
will be clinical benefit which will be defined as a decrease in HBI, fecal lactoferrin, CRP and/or ESR at 6 weeks compared with baseline values
Side effects data
From 2013 Phase 4 trial • 252 Patients • NCT013010662%
Headache
2%
Upper abdominal pain
2%
Blood CK increased
2%
Diarrhoea
2%
Fatigue
1%
Diverticulitis
1%
Atrial septal defect
1%
Enterovesical fistula
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
6,903 Total Patients Enrolled
University of VirginiaLead Sponsor
748 Previous Clinical Trials
1,235,963 Total Patients Enrolled
Brian Behm, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
10 Total Patients Enrolled
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