- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03423641
An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C
5 de agosto de 2019 actualizado por: Elizabeth A. McGlynn, Kaiser Permanente
Safety of Direct-Acting Antiviral Medications for Hepatitis C
The investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients with HCV who are untreated.
The investigators hypothesize that patients receiving DAAs do not experience higher rates of adverse events compared to patients who have not received DAAs.
The study population is adults between the ages of 18 and 88 with any indication of a diagnosis of HCV.
An intervention group (those receiving a DAA) and comparison group (those who are not treated) will be created using medication dispensing data.
Eligibility for the study will be determined from January 1, 2011 through December 31, 2017.
Covariates will be collected from January 1, 2011 through December 31, 2017.
Individual study sites may have access to historical data prior to 2011 that can be used as covariates or to identify individuals with HCV.
The primary outcomes of interest include acute myocardial infarction, neurological outcomes (e.g.
acute stroke, intracranial bleed), acute kidney failure, acute on chronic liver failure, hepatic decompensation, multiple organ dysfunction syndrome, cancer, bradyarrhythmia, and death.
The secondary outcomes include decompensated cirrhosis, hospitalization, emergency department visit, and arrhythmia.
Outcomes will be assessed from January 1, 2011 through December 31, 2017.
The investigators will use two different analytic approaches to answer the question of interest: a Poisson regression model and marginal structural modeling (MSM).
The simpler Poisson model is an extension of tabular rate of event analysis.
The more complicated MSM model incorporates modeling of the treatment decision to more flexibly control for confounding by indication.
For each outcome, the investigators will only record the first date an outcome occurs.
Each outcome will be modeled separately.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
33808
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 88 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
N/A
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
The groups/cohorts will consist of all HCV patients from Kaiser Permanente Southern California region, Kaiser Permanente Northern California region, and the OneFlorida Clinical Research Consortium.
Descripción
Inclusion Criteria:
- HCV viral load
- HCV genotype
- HCV qualitative
- HCV antibody
- HCV drug
- Continuously enrolled 12 months
Exclusion Criteria:
- Each outcome will be analyzed separately as time to first event, thus people who experience an outcome prior to their study start date are ineligible for analyses related to that particular outcome.
The results will be examined for sensitivity to the following possible exclusion criteria:
- Achieved SVR-12 prior to index date
- HCV treatment experienced prior to index date
- No visit in GI, Infectious Disease, or Liver Transplant / Hepatology
- No positive HCV test (genotype, viral load, or qualitative)
- No recent positive HCV test (genotype, viral load or qualitative)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Direct Acting Antivirals
Patients who receive a direct acting antiviral enter the DAA cohort at the time of initiation of the drug.
|
The time period during which a patient is dispensed the medication and for up to 180 days after initiation of the medication.
|
Comparison
The exposure time of patients who have not received a direct acting antiviral (patients can change from the comparison to the DAA group once they receive the medication)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of Acute Myocardial Infarction (AMI)
Periodo de tiempo: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Inpatient encounter with an ICD-9 diagnosis code of 410.xx or ICD-10 diagnosis code of I21.xx.
|
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of Acute on Chronic Liver Failure
Periodo de tiempo: Labs and diagnoses collected from clinical encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
An acute change in MELD (model for end stage liver disease) score of 5 or more and the change is deemed to have persisted (defined as meeting one of the following criteria: MELD continues to be elevated 3 months later, liver transplant, death).
The minimum value for the MELD is 6.43, but there is no maximum value.
Higher scores mean a worse outcome.
|
Labs and diagnoses collected from clinical encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of Acute Kidney Failure (AKF)
Periodo de tiempo: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Encounters with an ICD-9 diagnosis code of 584.xx or ICD-10 diagnosis code of N17.xx.
|
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of Multiple Organ Dysfunction Syndrome (MODS)
Periodo de tiempo: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Inpatient encounters with ICD-9 diagnosis code of 995.92, 995.94, 785.52 or ICD-10 code of R65.11 or R65.2x.
|
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Death
Periodo de tiempo: Death dates will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Date of death in one or more records.
Death data comes from medical records, Social Security, or state databases.
|
Death dates will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of Ischemic Stroke
Periodo de tiempo: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Inpatient encounters with ICD-9 diagnosis code of 433.xx, 434.xx or ICD-10 code of I63.xx, I65.xx.
|
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of Hemorrhagic Stroke
Periodo de tiempo: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Inpatient encounters with ICD-9 diagnosis code of 430.xx-432.xx
or ICD-10 code of I60.xx-I62.xx
|
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of Decompensated Cirrhosis
Periodo de tiempo: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
A patient will be characterized as having decompensated cirrhosis from an encounter indicating jaundice (ICD-9 diagnosis code of 782.4 or ICD-10 code of R17), ascites (ICD-9 diagnosis code of 789.5, 789.51, 789.59 or ICD-10 diagnosis code of R18.0, R18.8, K71.51, K70.11, or K70.31), or varices (ICD-9 diagnosis code of 456.0, 456.20 or ICD-10 diagnosis code of I85.01 or I85.11, or a medication dispense of lactulose or rifaximin along with a diagnosis of cirrhosis.
|
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Rate of Hospitalizations
Periodo de tiempo: Hospitalizations will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
An encounter in which the place of service is an inpatient hospitalization.
|
Hospitalizations will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Rate of Emergency Department Visits
Periodo de tiempo: ED visits will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
An encounter in which the place of service is an emergency department or urgent care center.
|
ED visits will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of Arrhythmia
Periodo de tiempo: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Inpatient encounters with an ICD-9 diagnosis code of 427.1, 427.42, 427.5, 427.9 or an ICD-10 diagnosis code of I47.2, I49.01, I49.02, I46.9, I49.9.
|
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of Liver Cancer
Periodo de tiempo: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Encounters with ICD-9 diagnosis code of 155.xx or ICD-10 code of C22.xx.
|
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of Cancers Other Than Liver Cancer
Periodo de tiempo: Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Encounters with ICD-9 codes 140.xx through 208.xx, except 155.xx or ICD-10 coes C00-C97 except C22.xx.
|
Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.
|
Incidence of HBV Reactivation
Periodo de tiempo: Labs will be for up to 180 days following the initiation of a DAA.
|
We identified HBV reactivations in three different ways [Di Bisceglie et al., 2015; Yanny et al., 2018]: (1) patients who had a history of Hepatitis B core antibody (HBcAb) positive and were Hepatitis B surface antigen (HBsAg) negative at the time of initiating DAA therapy who became HBsAg positive within 180 days after receiving a DAA; (2) patients with undetectable levels of HBV DNA at the time of initiating DAA therapy who had a numerical result within 180 days after receiving a DAA; (3) patients with a numerical HBV DNA result at the time of initiating DAA therapy whose viral load increased by a factor of 10 within 180 days after receiving a DAA.
For all methods of detecting a reactivation, we required that the reactivations be clinically significant: bilirubin at least 3, aspartate aminotransferase (AST) at least 400, or alanine aminotransferase (ALT) at least 500.
|
Labs will be for up to 180 days following the initiation of a DAA.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Elizabeth A McGlynn, PhD, Kaiser Permanente
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2011
Finalización primaria (Actual)
31 de diciembre de 2017
Finalización del estudio (Actual)
31 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
31 de enero de 2018
Primero enviado que cumplió con los criterios de control de calidad
31 de enero de 2018
Publicado por primera vez (Actual)
6 de febrero de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2019
Última verificación
1 de agosto de 2019
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
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Hepatitis Crónica
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C Crónica
- Agentes antiinfecciosos
- Agentes Antivirales
Otros números de identificación del estudio
- RI-RCR-1000
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
Current plan is to make a de-identified data set available to investigators under specified conditions.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
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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