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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

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ClinicalTrials.gov Identifier: NCT03301506
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: Seladelpar 2 mg Capsule Drug: Seladelpar 5 mg Capsule Drug: Seladelpar 10 mg Capsule Phase 2 Phase 3

Detailed Description:

Primary:

To evaluate the long-term safety and tolerability of seladelpar

Secondary:

To evaluate the long-term efficacy of seladelpar


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Seladelpar 2 mg Capsule Drug: Seladelpar 2 mg Capsule
Subjects will be assigned to a treatment group based on the seladelpar dose received at End of Treatment in a previous PBC study with seladelpar.
Other Name: MBX-8025

Experimental: Seladelpar 5 mg Capsules Drug: Seladelpar 5 mg Capsule
Subjects will be assigned to a treatment group based on the seladelpar dose received at End of Treatment in a previous PBC study with seladelpar.
Other Name: MBX-8025

Experimental: Seladelpar 10 mg Capsule Drug: Seladelpar 10 mg Capsule
Subjects will be assigned to a treatment group based on the seladelpar dose received at End of Treatment in a previous PBC study with seladelpar.
Other Name: MBX-8025




Primary Outcome Measures :
  1. Adverse events (AE) and Treatment Emergent Adverse Events (TEAEs), Biochemistry and Hematology and NCI CTCAE Version 4.0 [ Time Frame: Through study completion, up to 60 Months ]

Secondary Outcome Measures :
  1. Laboratory Value: Serum Alkaline Phosphatase (AP) [ Time Frame: Through study completion, up to 60 Months ]
    Serum Alkaline Phosphatase (AP)

  2. Laboratory Value: Aspartate Aminotransferase (AST) [ Time Frame: Through study completion, up to 60 Months ]
    Aspartate Aminotransferase (AST)

  3. Laboratory Value: Alanine Aminotransferase (ALT) [ Time Frame: Through study completion, up to 60 Months ]
    Alanine Aminotransferase (ALT)

  4. Laboratory Value: Gamma-glutamyl Transferase (GGT) [ Time Frame: Through study completion, up to 60 Months ]
    Gamma-glutamyl Transferase (GGT)

  5. Laboratory Value: 5'nucleotidase [ Time Frame: Through study completion, up to 60 Months ]
    5'nucleotidase

  6. Laboratory Value: Bilirubin - Total Bilirubin [ Time Frame: Through study completion, up to 60 Months ]
    Bilirubin - Total Bilirubin

  7. Laboratory Value: Bilirubin - Conjugated Bilirubin [ Time Frame: Through study completion, up to 60 Months ]
    Bilirubin - Conjugated Bilirubin

  8. Laboratory Value: Bilirubin - Unconjugated Bilirubin [ Time Frame: Through study completion, up to 60 Months ]
    Bilirubin - Unconjugated Bilirubin

  9. Laboratory Value: Bone Specific Alkaline Phosphatase (AP) [ Time Frame: Through study completion, up to 60 Months ]
    Bone Specific Alkaline Phosphatase (AP)

  10. Laboratory Value: Triglycerides (TG) [ Time Frame: Through study completion, up to 60 Months ]
    Triglycerides (TG)

  11. Laboratory Value: Total Cholesterol (TC) [ Time Frame: Through study completion, up to 60 Months ]
    Total Cholesterol (TC)

  12. Laboratory Value: High Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Through study completion, up to 60 Months ]
    High Density Lipoprotein Cholesterol (HDL-C)

  13. Laboratory Value: Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Through study completion, up to 60 Months ]
    Low Density Lipoprotein Cholesterol (LDL-C)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301506


Contacts
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Contact: Alexandra (Sasha) F Steinberg, MD, PhD 510-293-8817 ASteinberg@cymabay.com
Contact: Elaine Watkins 510-293-8132 ewatkins@cymabay.com

  Show 29 Study Locations
Sponsors and Collaborators
CymaBay Therapeutics, Inc.

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Responsible Party: CymaBay Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03301506     History of Changes
Other Study ID Numbers: CB8025-31731
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CymaBay Therapeutics, Inc.:
PBC
Primary Biliary Cholangitis (PBC)
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis