Phase 2b Study Of NGM282 Extended Treatment In Patients With Primary Biliary Cirrhosis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 14-006137
NCT ID: NCT02135536
Sponsor Protocol Number: 14-0104
About this study
The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Completion of NGM 13-0103
- Males or females, between 18 and 75 years of age, inclusive
- PBC Diagnosis consistent with AASLD and EASL guidelines
- Stable dose of UDCA
Exclusion Criteria:
- Chronic liver disease of a non-PBC etiology
- Evidence of clinically significant hepatic decompensation
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Hugo Vargas, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available