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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00364819 |
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Date of registration:
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15/08/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Initial Study of Rituximab to Treat Primary Biliary Cirrhosis
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Scientific title:
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Effects of Rituximab (Rituxan) on B Cell and AMA Response in Patients With Primary Biliary Cirrhosis |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00364819 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Christopher L Bowlus, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Davis |
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Name:
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M. Eric Gershwin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Davis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Liver biopsy showing histological PBC stages I, II, or III
- Presence of all criteria for the diagnosis of PBC
- serum AMA at titer >1:40
- alkaline phosphatase >2X normal value for >6 months
- compatible liver histology
- Incomplete response to UDCA after 6 months of treatment.
- Negative pregnancy test (female patients in fertile age)
- Adequate renal function (serum creatinine < 1.2)
Exclusion Criteria:
- End-stage/decompensated liver disease
- ascites
- jaundice with serum bilirubin > 2mg/dl
- history of digestive bleeding secondary to portal hypertension or endoscopic evidence
of varices at stage F2
- history of hepatic encephalopathy
- INR>1.2
- Other coexisting causes of liver disease
- Use of other immunosuppressive medications 4 weeks prior to enrollment
- Diuretics use
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cirrhosis
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Intervention(s)
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Drug: rituximab
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Primary Outcome(s)
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Number of Participants With Adverse Events
[Time Frame: 52 weeks]
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Secondary Outcome(s)
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Change in Serum Alkaline Phosphatase
[Time Frame: 52 Weeks]
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Change in Serum Immunoglobulin A
[Time Frame: 52 Weeks]
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Change in Serum Immunoglobulin G
[Time Frame: 52 Weeks]
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Change in Serum Immunoglobulin M
[Time Frame: 52 Weeks]
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Secondary ID(s)
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200614025
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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