Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/4/2019
Start Date:December 12, 2017
End Date:March 2022
Contact:Pol F Boudes, MD
Email:PBoudes@cymbay.com
Phone:510-293-8815

Use our guide to learn which trials are right for you!

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in
Subjects with Primary Biliary Cholangitis (PBC)

Primary:

To evaluate the long-term safety and tolerability of seladelpar

Secondary:

To evaluate the long-term efficacy of seladelpar

Inclusion Criteria:

1. Must have given written informed consent (signed and dated) and any authorizations
required by local law

2. Participated in a PBC study with seladelpar

3. Females of reproductive potential must use at least one barrier contraceptive and a
second effective birth control method during the study and for at least 90 days after
the last dose. Male subjects who are sexually active with female partners of
reproductive potential must use barrier contraception and their female partners must
use a second effective birth control method during the study and for at least 90 days
after the last dose

Exclusion Criteria:

Exclusion criteria are applicable only for subjects with study drug interruption greater
than four weeks prior to Day 1 of this study.

1. Treatment-related adverse event leading to study drug discontinuation in a previous
PBC study with seladelpar (MBX-8025)

2. A medical condition, other than PBC, that in the investigator's opinion would preclude
full participation in the study or confound its results (e.g., cancer)

3. AST or ALT above 3 × ULN

4. Total bilirubin above 2.0 mg/dL

5. Creatine kinase above 2.5 × ULN

6. Serum creatinine above 1.5 × ULN

7. Auto-immune hepatitis

8. Primary sclerosing cholangitis

9. Known history of alpha-1-antitrypsin deficiency

10. Known history of chronic viral hepatitis

11. For females, pregnancy or breast-feeding

12. Use of colchicine, methotrexate, azathioprine, or systemic steroids within two months
prior to screening

13. Current use of fibrates or simvastatin

14. Current use of obeticholic acid

15. Use of an experimental or unapproved treatment for PBC

16. Use of experimental or unapproved immunosuppressant

17. Any other condition(s) that would compromise the safety of the subject or compromise
the quality of the clinical study, as judged by the Investigator
We found this trial at
17
sites
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Atlanta, Georgia 30309
Phone: 404-355-3200
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Calgary,
Click here to add this to my saved trials
Coronado, California 92118
Phone: 619-990-1698
?
mi
from
Coronado, CA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Jackson, Mississippi 39216
Phone: 769-251-5674
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Live Oak, Texas 78233
Phone: 210-447-9500
?
mi
from
Live Oak, TX
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
462 1st Avenue
New York, New York 10010
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport News, Virginia 23602
?
mi
from
Newport News, VA
Click here to add this to my saved trials
Novi, Michigan 48377
?
mi
from
Novi, MI
Click here to add this to my saved trials
Palo Alto, California 94305
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials