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Estudio sobre la eficacia del fármaco EP547 para el alivio del prurito colestático en pacientes con colangitis biliar primaria o colangitis esclerosante primaria

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    ¿De qué trata este estudio?

    Este estudio tiene como objetivo evaluar la eficacia del potencial nuevo fármaco EP547 en el alivio del prurito colestático en personas de 18 a 80 años con colangitis biliar primaria (PBC) o colangitis esclerosante primaria (PSC). Los criterios de inclusión involucran diagnósticos documentados de PBC o PSC, la presencia de prurito de moderado a severo, y la aceptación de medicamentos antiprurísticos y anticolestáticos específicos. Los criterios de exclusión incluyen prurito no relacionado con PBC o PSC, antecedentes de trasplante de hígado, cirrosis, enfermedades hepáticas alternativas, colangitis esclerosante secundaria, estenosis significativas o stents biliares, resección de intestino delgado, y ciertos resultados de laboratorio que indiquen la no elegibilidad.

    Más información sobre este ensayo

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      Ubicaciones

      ¿Dónde se realiza el ensayo clínico?

      Puedes unirte a este estudio en:

      ¿Cuáles son los próximos pasos del estudio?

      ¿Cuál será la complejidad de mi estudio y por qué etapas pasaré?

      Based on the information provided about this clinical trial, here are the key steps a patient would likely need to take if participating:

      1. Screening: The patient would be evaluated against the inclusion/exclusion criteria to determine if they are eligible to participate. This includes being 18-80 years old, having documented PBC or PSC, and having consistent moderate to severe pruritus (itching).
      2. Randomization: If deemed eligible after screening, the patient would be randomly assigned to receive either the investigational drug EP547 (100mg once daily) or a placebo for comparison.
      3. Treatment Period: The patient would take their assigned treatment (EP547 or placebo) once daily for 6 weeks. During this time:
        • Pruritus intensity would be measured using the Worst Itch Numeric Rating Scale (WI-NRS) and other itch questionnaires
        • Safety would be monitored by tracking any adverse events
        • Blood samples would likely be collected to measure EP547 levels for pharmacokinetic analysis
      4. End of Treatment: After the 6 week treatment period, a final evaluation would be done to assess the patient’s pruritus and compare to baseline scores to determine if the drug had an effect. This would mark the end of the patient’s active participation.

      In summary, the key commitment for a patient would be taking a daily oral medication for 6 weeks and attending any required study clinic visits for assessments and blood draws over that period. The entire process from screening to end of treatment looks to last about 6-8 weeks total.


      Enfermedades en investigación

      ¿Qué condiciones me cualifican para este estudio?

      Based on the eligibility criteria in the provided clinical trial information, to join this study you need to have one of the following diseases:

      • Documented primary biliary cholangitis (PBC), or
      • Documented primary sclerosing cholangitis (PSC)

      You would not be eligible if you have:

      • Pruritus (itching) associated with a cause other than PBC or PSC
      • Evidence of compensated or decompensated cirrhosis
      • Alternative causes of liver disease
      • Documented secondary sclerosing cholangitis

      Criterios de inclusión y exclusión

      ¿Qué requisitos debo cumplir para participar en este estudio?

      ¿Cuándo puedo participar en el estudio?

      To join this clinical trial, you must meet the following criteria:

      Inclusion Criteria:

      • Age 18 to 80 years old
      • Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)
        • PBC and PSC are both chronic liver diseases that cause inflammation and scarring of the bile ducts
      • Presence of consistent moderate to severe pruritus (itching)
      • Use of anti-pruritic (anti-itch) and anti-cholestatic (bile flow improving) medication is allowed, including:
        • Ursodeoxycholic acid (UDCA)
        • Obeticholic acid

        As long as you meet additional criteria

      • If you have concomitant inflammatory bowel disease (IBD), which commonly occurs alongside PSC, you must meet additional relevant criteria

      The trial does not mention any specific indexes or scales in the inclusion criteria that require further explanation.

      In summary, the main conditions are being 18-80 years old, having documented PBC or PSC, experiencing consistent moderate to severe itching, and being allowed to continue certain medications for itching and bile flow. Additional criteria apply for those with IBD.

      ¿Qué motivos podrían excluirme del estudio?

      Based on the eligibility criteria, you cannot take part in the study if you have any of the following:

      Other causes of pruritus (itching):
      If your pruritus is due to a cause other than primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC), you are not eligible. PBC and PSC are chronic liver diseases that can cause itching.

      Previous or planned liver transplant:
      If you have had a liver transplant in the past or are planning to have one, you cannot participate.

      Cirrhosis:
      Cirrhosis is severe scarring of the liver. If you have either compensated cirrhosis (milder form) or decompensated cirrhosis (more advanced form with complications), you are excluded.

      Other liver diseases:
      If you have other causes of liver disease besides PBC or PSC, you cannot take part.

      Secondary sclerosing cholangitis:
      This is a type of liver disease similar to PSC but caused by a known separate condition. If you have documented secondary sclerosing cholangitis, you are not eligible.

      Severe bile duct narrowing or stents:
      If you currently have significant narrowing (strictures) of the bile ducts or have a biliary stent in place, you cannot participate.

      Bowel surgery:
      If you have a history of major small intestine resection surgery or short bowel syndrome, you are excluded.

      Abnormal lab results:
      Certain abnormal laboratory or biochemical results at the screening visit will prevent you from participating.


      Producto medicinal en investigación

      ¿Qué productos se utilizan en este estudio?

      The drugs involved in this study are:

      1. EP547 (active substance unknown): This is the investigational drug being evaluated for its effects on cholestatic pruritus in patients with Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC). EP547 is administered once daily in the treatment arm of the study.
      2. Placebo: A placebo is a substance with no active therapeutic effect, used as a control in the study to compare against the investigational drug EP547. It is administered once daily in the placebo arm of the study.

      The study is designed to evaluate the efficacy and safety of EP547 in reducing pruritus (itching) in patients with PBC or PSC. Participants are randomly assigned to receive either EP547 or placebo for 6 weeks, and the severity of their pruritus is measured using various scales and questionnaires. The use of a placebo helps determine if any observed improvements are due to the active drug or other factors.

      ¿Se han estudiado previamente en medicina las sustancias medicinales utilizadas en el ensayo?

      Based on the information provided in the clinical trial record, the active substances being studied are:

      1. EP547
        • EP547 appears to be an investigational drug being developed by Escient Pharmaceuticals. As an investigational therapy, it is likely a novel compound that is not yet well established in medical literature or approved as a treatment.
      2. Placebo
        • Placebos are inactive substances used as a control in clinical trials. They are well known and widely used in medical research to help determine the effectiveness of the investigational treatment.

      ID del estudio

      CT-EU-00057508

      Estado de reclutamiento

      Recruting new patients

      Inicio del juicio

      2 años ago

      Producto medicinal

      Enfermedades