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Immunomodulator

Abatacept 125 mg weekly for Primary Biliary Cirrhosis (PBC Trial)

Phase 4
Waitlist Available
Led By Christopher L Bowlus, MD
Research Sponsored by Christopher Bowlus, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 4, 12, 24, and 36
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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).

Eligible Conditions
  • Primary Biliary Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 4, 12, 24, and 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 4, 12, 24, and 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biochemical Response
Secondary study objectives
Absolute Change in Alanine Transferase (ALT)
Absolute Change in Alkaline Phosphatase
Drug Safety
+4 more
Other study objectives
Abatacept Levels
Immunoglobulin M (IgM) Levels
Memory T Cell Frequencies

Side effects data

From 2018 Phase 4 trial • 16 Patients • NCT02078882
13%
Nausea
6%
Right upper quadrant pain
6%
Upper respiratory infection
6%
Hilar Adenopathy
6%
Urinary Tract Infections
6%
Vomiting
6%
Elevated liver enzymes
6%
Urticarial Rash
6%
Chest Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept 125 mg Weekly

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Abatacept 125 mg weeklyExperimental Treatment1 Intervention
Open label treatment with Abatacept
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
FDA approved

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,553 Total Patients Enrolled
Christopher Bowlus, MDLead Sponsor
Christopher L Bowlus, MDPrincipal InvestigatorUniversity of California, Davis
3 Previous Clinical Trials
131 Total Patients Enrolled
~1 spots leftby Nov 2025
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