Initial Study of Rituximab to Treat Primary Biliary Cirrhosis

NCT00364819 | Completed Phase 1 Results DMC

• 1 other identifier: 200614025
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Primary Biliary Cirrhosis (PBC). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with PBC, a disease of the immune system. However, the safety of rituximab in PBC patients must first be established.

Conditions

Primary Biliary Cirrhosis

Keywords

Primary Biliary Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  52 weeks

Secondary Outcomes (4)

• Change in Serum Immunoglobulin G

  52 Weeks

• Change in Serum Immunoglobulin A

  52 Weeks

• Change in Serum Immunoglobulin M

  52 Weeks

• Change in Serum Alkaline Phosphatase

  52 Weeks

Study Arms (1)

1

EXPERIMENTAL

rituximab 1000 mg IV on days 1 and 15, given over 5 - 6 hours

Drug: rituximab

Interventions

rituximab DRUG

rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours

Also known as: Rituxan (R)

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Links

• American Liver Foundation
• Primary Biliary Cirrhosis Organization

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Christopher L. Bowlus, MD
• Organization: University of California Davis

clbowlus@ucdavis.edu

916-734-8986

Study Officials

• M. Eric Gershwin, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Christopher L Bowlus, MD

  University of California, Davis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2006
• First Posted: August 16, 2006
• Study Start: January 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 2, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)