ASSURE: Estudio abierto a largo plazo para evaluar la seguridad y tolerabilidad de seladelpar en sujetos con colangitis biliar primaria (PBC)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03301506Tipo: INTERVENTIONALInicio: 12 de dic de 2017Fin estimado: 1 de nov de 2028

Resumen

Estudio abierto a largo plazo para evaluar la seguridad y tolerabilidad de seladelpar en sujetos con colangitis biliar primaria (PBC).

Descripción detallada

Primario: Evaluar la seguridad y tolerabilidad a largo plazo de seladelpar. Secundario: * Evaluar la eficacia a largo plazo de seladelpar. * Evaluar el efecto de seladelpar sobre los resultados comunicados por el paciente (prurito).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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 individuals 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

Criterios de exclusión

Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection)
AST or ALT above 3 × the upper limit of normal (ULN)
Total bilirubin above 2 × ULN
MELD score ≥ 12. For individuals 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 (eg 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 individual or compromise the quality of the clinical study, as judged by the Investigator
Immunosuppressant therapies (eg, 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:
Hepatitis B, defined as the presence of hepatitis B surface antigen
Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
Human immunodeficiency virus (HIV) antibody
Active COVID-19 infection during screening

Intervenciones

drug

Seladelpar 5 mg Capsule

Participants will be assigned to a treatment group if tolerability issues noted in the previous study.

drug

Seladelpar 10 mg Capsule

Participants will be assigned to a treatment group unless there are tolerability issues.

Ubicaciones

CINME S.A. - Centro de Investigaciones Metabólicas-Viamonte 2278

Balvanera, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

DIM Clínica Privada

El Palomar, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

Patrocinadores

PrincipalGilead Sciences

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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