NCT02078882

Brief Summary

The purpose of this study is to determine if abatacept (Orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment with ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 30, 2020

Completed
Last Updated

April 9, 2020

Status Verified

March 1, 2020

Enrollment Period

4.1 years

First QC Date

March 3, 2014

Results QC Date

January 27, 2020

Last Update Submit

March 28, 2020

Conditions

Primary Biliary Cirrhosis

Keywords

Primary Biliary CirrhosisUrsodeoxycholic acidAbataceptCytotoxic T-Lymphocyte Antigen 4 (CTLA-4)

Outcome Measures

Primary Outcomes (1)

  • Biochemical Response

    Number of Participants with a decrease of alkaline phosphatase by \> 40%of the Day 0 level at 24 weeks of treatment.

    Week 24

Secondary Outcomes (7)

  • Drug Safety

    Weeks 2, 4, 12, 24, and 36

  • Absolute Change in Alkaline Phosphatase

    Week 24

  • Absolute Change in Alanine Transferase (ALT)

    Week 24

  • Liver Stiffness Measured by Magnetic Resonance Elastography

    Week 24

  • Primary Billiary Cholangitis Quality of Life

    Week 24

  • +2 more secondary outcomes

Other Outcomes (3)

  • Immunoglobulin M (IgM) Levels

    Week 24

  • Memory T Cell Frequencies

    Week 24

  • Abatacept Levels

    Day 0 and Weeks 4, 12, 24, and 36

Study Arms (1)

Abatacept 125 mg weekly

EXPERIMENTAL

Open label treatment with Abatacept

Biological: abatacept

Interventions

abataceptBIOLOGICAL

125 mg subcutaneously each week for 24 weeks

Also known as: Orencia
Abatacept 125 mg weekly

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed PBC diagnosis based upon at least 2 of 3 criteria
  • Anti-mitochondrial antibody (AMA) titer \> 1:40
  • Alkaline phosphatase \> 1.5 times the upper limit of normal for at least 6 months
  • Liver biopsy findings consistent with PBC
  • Incomplete response to UDCA defined by an alkaline phosphatase \> 1.67 X the upper limit of normal after 6 months of UDCA at a minimum dose of 13 mg/kg/d
  • Taking a stable dose of UDCA for at least 3 months prior to Day 0
  • aspartate aminotransferase (AST) and alanine aminotransferase ALT \< 5 times the upper limit of normal

You may not qualify if:

  • Presence of concomitant liver diseases including viral hepatitis, primary sclerosing cholangitis, alcoholic liver disease, Wilson's disease, hemochromatosis, or Gilbert's syndrome.
  • Prior liver transplantation
  • Decompensated liver disease
  • Use of immunosuppressants within 6 months of Day 0
  • Use of biologic agents within 12 months of Day 0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Links

MeSH Terms

Conditions

Liver Cirrhosis, BiliaryDiabetes Mellitus, Insulin-Dependent, 12

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Results Point of Contact

Title
Christopher L Bowlus
Organization
University of California Davis
clbowlus@ucdavis.edu
9167348696

Study Officials

  • Christopher L Bowlus, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • M. Eric Gershwin, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Gastroenterology and Hepatology, Internal Medicine

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

April 9, 2020

Results First Posted

March 30, 2020

Record last verified: 2020-03

Locations

US(1)