- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04546802
HepATocellular Cancer Hcv Therapy Study (HATCHeT)
Open Label Trial to Study the Efficacy and Safety of MK-5172 and MK-8742 +/- Ribavirin (RBV) in the Treatment of Hepatitis C G1 and 4, in Patients Eligible for Liver Transplant (HCC) or Curative Therapy or Clinically Stable Disease Post Local Resection, Embolization or Ablative Therapy
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Two cohorts (A and B) of patients with chronic HCV infection will be enrolled. Patients will be eligible for enrollment if they fulfill the study inclusion and exclusion criteria and have achieved a complete tumour response (CR) 3 months (+/- 14 days) following HCC treatment
- Cohort A: Patients with Barcelona Clinic Liver Cancer (BCLC) stage 0 or A HCC who have received curative therapy defined as either; liver transplantation, surgical resection or local ablation with curative intent and attained a radiologically confirmed CR. (N=50)
- Cohort B: Patients who are non-eligible for curative therapy but have attained a radiologically confirmed CR. post embolization or ablative therapy and have chronic HCV infection. (N=50) Given the existing uncertainty regarding the impact of direct acting antiviral (DAA) therapy on HCC recurrence, study participants will be randomized to receive DAA treatment as "immediate" ie upon study enrollment or "delayed" ie treatment commenced ≥ 6months following documentation of complete response based on radiological assessment indicating no residual arterial enhancing disease..
Tipo de estudio
Fase
- Fase 3
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Hepatitis C diagnosed as the HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
- Genotype inclusions
- Have documented chronic HCV GT1 or GT4, (with no evidence of nontypeable or mixed genotype) infection
- HCC diagnosed on the basis of histology or according to AASLD radiological criteria,
- Written informed consent granted prior to initiation of any study-specific screening procedures
- Patients aged 18 to 70 years-old;
- Child-Pugh ≤≤ A6
- BCLC stage 0, A HCC or no detectable HCC in a patient who has undergone a curative form of treatment (liver transplantation, surgical resection of local ablative therapy with curative intent) OR BCLC-B disease but clinically stable with non-evidence of disease progression as demonstrated by either Triphasic CT or contrast MRI at least 3 months after the last HCC treatment.
Exclusion Criteria:
Enrolment in other investigation / experimental therapies
- Prior or current use of Sorafenib or other systemic chemotherapy
- Life expectancy < 12 months (unless transplantation eligible)
- Unable to provide informed consent
- Previous or concurrent cancer that is distinct from HCC in primary site or histology, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to enrollment is permitted.
- Any condition that in the opinion of the investigator would impair participation in the trial.
- Coinfected with human immunodeficiency virus (HIV) infection or Hepatitis B virus (e.g. HBsAg positive).
- History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification within 6 months prior to study entry; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as ≥ Grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is permitted)
- Active clinically serious infections defined as ≥ Grade 3 according to NCI CTCAE, version 4.03 6. Any medical, psychological, or social conditions, particularly if unstable, including substance abuse, that may, in the opinion of the Investigator, interfere with the subject's safety or participation in the study, protocol compliance, or evaluation of the study results
- Concomitant interferon therapy or therapies for active Hepatitis C Virus (HCV) infection. Prior interferon and/or ribavirin therapy is not a contraindication to enrolment however previous treatment with direct acting antiviral treatment is an exclusion
- Pregnancy or breast-feeding
- Inability to swallow oral medications
- Clinically significant gastrointestinal bleeding occurring ≤ 3 months prior to study entry or Large gastric-esophageal varices (larger than 5 cm) or previous history of gastric-esophageal bleeding due to varices.
Fulfills exclusion criteria on biochemistry results:
- Creatinine Clearance <50 mL/min
- Hemoglobin <11 g/dL for females and <12 g/dL for males
- Platelets <75 x 103/μL
- Serum Albumin < 3.0 g/dL
- INR >1.7
- HbA1c >10%
- ALT >10XULN, AST >10XULNtherapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Immediate treatment
This group will undergo immediate treatment of the HCV once HCC complete response (CR) has been confirmed
|
Elbasvir / Grazoprevir
|
Comparador activo: Delayed treatment
This group will delay commencement of the HCV treatment until 6 months after HCC complete response (CR) has been confirmed
|
Elbasvir / Grazoprevir
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Viral eradication
Periodo de tiempo: 12 weeks
|
Eradication of Hepatitis C virus determined by undetectable viral load
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Supervivencia libre de enfermedad
Periodo de tiempo: 5 años
|
Supervivencia libre de enfermedad
|
5 años
|
HCC recurrence rate following HCC treatment
Periodo de tiempo: 6 and 12 month
|
impact of DAA therapy on 6 and 12 month HCC recurrence rate following HCC treatment
|
6 and 12 month
|
Recurrence free survival
Periodo de tiempo: 5 years
|
Recurrence free survival
|
5 years
|
Time to HCC recurrence / progression
Periodo de tiempo: 5 years
|
Time to HCC recurrence / progression
|
5 years
|
Adverse events
Periodo de tiempo: Up to 5 years
|
Safety and tolerability of Elbasvir/grazoprevir determined by adverse events
|
Up to 5 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall survival
Periodo de tiempo: Up to 5 years
|
Overall survival determined by proportion surviving
|
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: William kemp, MBBSFRACPPhD, The Alfred
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Neoplasias Hepaticas
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Carcinoma
- Hepatitis
- Carcinoma Hepatocelular
- Hepatitis A
- Hepatitis C
- Agentes antiinfecciosos
- Agentes Antivirales
- Grazoprevir
- Combinación de fármacos elbasvir-grazoprevir
Otros números de identificación del estudio
- 288/18
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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