E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C |
Hepatitis C crónica |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C |
Hepatitis C crónica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the durability of virologic response in subjects previously treated with BMS-650032 and/or BMS-790052 who achieved Sustained Virologic Response (SVR12) in the previous study. |
Determinar la durabilidad de la respuesta virológica en pacientes tratados anteriormente con Asunaprevir (BMS-650032) y/o Daclatasvir (BMS-790052) que alcanzaron una respuesta virológica sostenida (RVS12) en el estudio anterior. |
|
E.2.2 | Secondary objectives of the trial |
? To assess the presence of HCV sequence variants over time in subjects previously treated with BMS-650032 and/or BMS-790052 who did not achieve SVR12 or relapsed after achieving SVR12 in the previous study. ? To characterize the long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all-cause mortality, and liver-related mortality, among subjects previously treated with BMS-650032 and/or BMS-790052. |
?Evaluar la presencia de variantes de la secuencia del VHC con el tiempo en sujetos tratados previamente con Asunaprevir y/o Daclatasvir que no alcanzaron una RVS12 o recidivaron después de alcanzar una RVS12 en el estudio anterior. ?Describir la progresión de la hepatopatía a largo plazo, medida por la frecuencia de progresión de la hepatopatía, la mortalidad por todas las causas y la mortalidad por causa hepática entre los sujetos tratados en pacientes tratados anteriormente con Asunaprevir (BMS-650032) y/o Daclatasvir (BMS-790052) para la hepatitis C crónica en el estudio previo. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Received at least one dose of asunaprevir and/or daclatasvir and completed participation in a previous study a) Subjects participating in daclatasvir and/or asunaprevir studies may enroll regardless of virologic response (subjects who received control agents, eg, placebo, will be allowed to participate until unblinded treatment information is released for the parent protocol; at that time subjects will have the option to continue in the study) b) Subjects participating in BMS-914143 (pegylated interferon lambda 1a) studies must have HCV RNA >=LOQ at the completion of the posttreatment follow-up period 2. Enrolled within 6 months of completing previous study or within 6 months of protocol availability at the clinical site |
1)Los sujetos deben haber recibido al menos una dosis de asunaprevir y/o daclatasvir y haber terminado su participación (esto es que hayan completado el período de seguimiento postratamiento) en un estudio previo a)Los sujetos que participan en estudios de daclatasvir y/o asunaprevir (es decir, los números de protocolo que empiezan por AI444 o AI447) pueden reclutarse independientemente de la respuesta virológica; además, los sujetos que recibieron agentes de control (p. ej. placebo) en el ensayo original podrán participar hasta que se disponga de la información desenmascarada sobre el tratamiento del protocolo original; en ese momento todos los sujetos tendrán la opción de continuar en el estudio) b)Los sujetos que participan en estudios de Lambda (es decir, los números de protocolo que empiezan por AI452) deben tener ARN del VHC >= LDC al finalizar el período de seguimiento postratamiento. 2)Deben participar en este estudio en los 6 meses siguientes a la terminación del estudio de BMS o en los 6 primeros meses de disponibilidad del protocolo en el centro clínico |
|
E.4 | Principal exclusion criteria |
1. Treatment with any antiviral or immunomodulatory drug for hepatitis C after completion of the previous study |
1)Los sujetos no deben haber recibido tratamiento con ningún fármaco antiviral o inmunomodulador para la Hepatitis C después de terminar el estudio previo durante el que se administró asunaprevir y/o daclatasvir . |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with BMS-650032 and/or BMS-790052. |
La durabilidad de la respuesta virológica, evaluada por el tiempo transcurrido hasta la pérdida de la respuesta virológica después de alcanzar una RVS12 en un estudio previo de asunaprevir y/o daclatasvir. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Loss of virologic response assessed using HCV RNA at 24-week intervals |
Pérdida de la respuesta virológica evaluada usando ARN del VHC a intervalos de 24 semanas |
|
E.5.2 | Secondary end point(s) |
- Frequency of viral genotypic substitutions in subjects previously treated with asunaprevir and/or daclatasvir who did not achieve or did not maintain SVR12 - Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all-cause mortality, and liver-related mortality |
?Frecuencia de sustituciones genotípicas en los intervalos de análisis entre sujetos previamente tratados con asunaprevir y/o daclatasvir que no alcanzaron o no mantuvieron una RVS12 en el estudio previo. ?Frecuencia de progresión de la hepatopatía, mortalidad por todas las causas y mortalidad por causa hepática durante el seguimiento a largo plazo entre los sujetos tratados para la hepatitis C crónica en el estudio previo. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Assessed using resistance testing samples at 24-week intervals - Assessed at 24-week intervals |
-Evaluación usando análisis de resistencia a intervalos de 24 semanas.
-Evaluación a intervalos de 24 semanas |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Prospective, observational, long-term follow-up study of subjects who participated in a BMS-650032 and/or BMS-790052 clinical trial |
Estudio prospectivo, observacional, de seguimiento a largo plazo de los sujetos que participaron en un ensayo clínico en el que se administró asunaprevir (BMS-650032) y/o daclatasvir (BMS-790052) |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belgium |
Brazil |
Canada |
Denmark |
France |
Germany |
Ireland |
Italy |
Japan |
Mexico |
New Zealand |
Puerto Rico |
Spain |
Sweden |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LSLV |
Ultima visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |