|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00588302 |
|
Date of registration:
|
22/12/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Moexipril for Primary Biliary Cirrhosis
|
|
Scientific title:
|
Open-Label Pilot Investigation of Moexipril for the Treatment of Primary Biliary Cirrhosis (PBC) |
|
Date of first enrolment:
|
June 2003 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00588302 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Keith D Lindor, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic and Foundation |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- PBC patients treated with UDCA (daily dose of 13 to 15 mg/kg for at least 6 months)
and an incomplete response defined by persistent elevation of serum alkaline
phosphatase activity at least 2 times the upper limit of normal
Exclusion Criteria:
- age less than 18 years
- pregnancy or nursing
- anticipated need for liver transplantation within 1 year with less than a 80%
one-year survival determined by the Mayo risk score
- complications of cirrhosis such as recurrent variceal hemorrhage, portosystemic
encephalopathy, and refractory ascites
- history of coexistent severe cardiovascular disease including aortic stenosis
- history of coexistent severe renal disease (defined as elevation of serum creatinine
more than 1.5 mg/dL) including renal artery stenosis
- history of allergy to ACE inhibitors
- current use of an ACE inhibitors or AT1 receptor antagonists in the past 3 months
- previous treatment with immunosuppressive agents or any experimental drug in the
preceding 3 months.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Primary Biliary Cirrhosis
|
|
Intervention(s)
|
|
Drug: Moexipril
|
|
Primary Outcome(s)
|
|
change in liver biochemistries and Mayo risk score for PBC
[Time Frame: 12 months]
|
|
Secondary Outcome(s)
|
|
change in health-related quality of life in PBC
[Time Frame: 12 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|