Last updated 26 days ago

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

500 patients around the world

Available in Argentina, United States, Spain

Primary: To evaluate the long-term safety and tolerability of seladelpar Secondary: - To evaluate the long-term efficacy of seladelpar - To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)

CymaBay Therapeutics, Inc.

10Research sites

500Patients around the world

Requirements for the patient

To 75 Years

All Gender

Medical requirements

: Must have given written informed consent (signed and dated)
Participated in a PBC study with seladelpar
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 are only applicable for subjects with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption.
Treatment-related adverse event (AE) leading to seladelpar discontinuation in a previous PBC study with seladelpar (MBX-8025)
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)
AST or ALT above 3 × the upper limit of normal (ULN)
Total bilirubin above 2 × ULN
MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
Auto-immune hepatitis
Primary sclerosing cholangitis
Known history of alpha-1-antitrypsin deficiency
Known history of chronic viral hepatitis
For females, pregnancy or breast-feeding
Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
Current use of fibrates or use of fibrates within 3 months prior to Screening
Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
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
Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis
Positive for: 1. Hepatitis B, defined as the presence of hepatitis B surface antigen 2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA) 3. Human immunodeficiency virus (HIV) antibody
Active COVID-19 infection during screening

Sites

CEDIMBA - DIM Clínica Privada - Buenos Aires

Recruiting

Belgrano 136, Ramos Mejia, Buenos Aires.

Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires

Recruiting

Viamonte, Cdad. Autónoma de Buenos Aires, Argentina

Hospital Italiano de Buenos Aires - CABA, Buenos Aires

Recruiting

Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH

Hospital Italiano de La Plata

Recruiting

Av. 51 entre 29 y 30 Nro 1725, La Plata, Buenos Aires

Centro Clinico Mediterráneo

Recruiting

Las Américas 1804, La Serena, Coquimbo

Hospital Universitario Virgen de la Victoria

Recruiting

Málaga, 29010

Hospital Universitario Germans Trias i Pujol

Recruiting

Carretera del Canyet, s/n 08916 Badalona

Hospital Vall de Hebrón

Recruiting

Pg. de la Vall d'Hebron, 119, 129, 08035 Barcelona, Spain

Hospital Universitario 12 de Octubre

Recruiting

Av. de Córdoba, s/n, 28041 Madrid

Hospital Universitario La Paz

Recruiting

Madrid, 28046

SponsorCymaBay Therapeutics, Inc.

Study typeInterventional

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT03301506