E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C Infection |
Epatite C |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C Infection |
Epatite C |
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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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
The primary objectives of this study are to assess the safety and to compare the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment) of co-formulated Ombitasvir/ABT-450/Ritonavir co-administered with RBV for 12 or 16 weeks to a clinically relevant threshold (based on SVR rates for HCV genotype 4-infected subjects treated with pegIFN/RBV) in HCV genotype 4-infected adults with compensated cirrhosis. |
Gli obbiettivi primari di questa sperimentazione sono di valutare la sicurezza e comparare la percentuale di soggetti che hanno raggiunto una risposta virologica sostenuta a 12 settimane, SVR12 (HCV acido ribonucleico (RNA) < limite inferiore di quantificazione (LLOQ) 12 setimane dopo il trattamento con la co-formulazione di ombitasvir/ABT-450/ritonavir in co-somministrazione con RBV per 12 o 16 settimane a una soglia clinicamente rilevante (che si basa sui tassi di SVR nei soggetti con infezione da HCV di genotipo 4 trattati con pegIFN/RBV) in soggetti con infezione da HCV di genotipo 4 e cirrosi compensata. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to compare SVR12 between the 12- and 16- week treatment arms, to assess the percentage of subjects with on-treatment virologic failure in each treatment arm, and to assess the percentage of subjects experiencing post-treatment relapse within 12 weeks following end of treatment (Relapse12) in each treatment arm. |
Come obiettivi secondari, questa sperimentazione intende confrontare i tassi di SVR12 fra il braccio di trattamento della durata di 12 settimane e il braccio di trattamento della durata di 16 settimane, valutare la percentuale di soggetti che manifestano fallimento virologico durante il trattamento per ciascun braccio di trattamento e valutare la percentuale di soggetti che manifestano una recidiva post trattamento nelle 12 settimane successive alla conclusione del trattamento (Recidiva12) per ciascun braccio di trattamento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Subjects must meet one of the following:
* Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
* Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV);
- Chronic HCV genotype 4 infection with cirrhosis.
- Subject has plasma HCV RNA level > 1,000 IU/mL at Screening |
- I soggetti devono soddisfare una delle seguenti caretteristiche:
* Naive al trattamento: Soggetti che non hanno mai ricevuto un trattamento antivirale per infezione da epatite C o
* Trattati in precedenza (Precedenti null responders, Partial responders o Relapsers all’IFN/RBV);
- Infezione cronica da epatite C di genotipo 4 con cirrosi.
- Soggetti con livelli di HCV RNA nel plasma > 1,000 IU/mL allo Screening
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E.4 | Principal exclusion criteria |
-Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
-Current enrollment in another interventional clinical study, previous enrollment in this study, or previous use of any protease inhibitor, non-nucleoside polymerase inhibitor, or NS5a inhibitor, either investigational or experimental (including previous exposure to ABT-450 or ombitasvir), or receipt of any investigational product within 6 weeks prior to study drug administration
-Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation including ascites, variceal bleeding, or hepatic encephalopathy
-Confirmed presence of hepatocellular carcinoma
-Any cause of liver disease other than chronic HCV infection
-Abnormal laboratory tests. |
- Risultato del test positivo allo screening per gli antigeni di superficie dell’epatite B (HBsAg) o agli anticorpi contro il virus dell’immunodeficienza umana (HIV Ab)
- Attualmente arruolato in un altro studio clinico interventistico, precedente arruolamento in questo studio, o un precedente uso di qualsiasi inibitore delle proteasi, inibitore delle polimerasi non-nucleosidico, o inibitore di NS5a, sia in fase di sperimentazione o sperimentale (compresa la precendente esposizione all’ABT-450 o ombitasvir), o la ricezione di qualsiasi prodotto sperimentale entro 6 settimane prima della somministrazione del farmaco in studio
- Qualsiasi presente o passata evidenza clinica di classificazione di Child-Pugh B o C, o storia clinica di scompenso epatico tra cui ascite, sanguinamento da varici esofagee, o encefalopatia epatica
- Confermata presenza di carcinoma epatocellulare
- Qualsiasi causa di malattia epatica diversa dall’infezione cronica da HCV
- Test di laboratorio anormali
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the percentage of subjects with SVR12. |
L’endpoint primario di efficacia è la percentuale di soggetti con SVR12. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after last dose of study drugs |
12 settimane dopo l’ultima dose del farmaco in studio |
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E.5.2 | Secondary end point(s) |
a) The percentage of subjects with sustained virologic response 12 weeks post treatment in Arm A (12 weeks treatment) compared to Arm B (16 weeks treatment)
b) Percentage of subjects in each treatment arm with on-treatment virologic failure during the Treatment Period
c) Percentage of subjects in each arm with post-treatment relapse |
a) La percentuale di soggetti con risposta virologica sostenuta 12 settimane dopo il trattamento nel braccio A (12 settimane di trattamento) comparato al braccio B (16 settimane di trattamento)
b) Percentuale di soggetti in ciascun braccio di trattamento che manifestano fallimento virologico durante il trattamento, nel corso del Periodo di trattamento
c) Percentuale di soggeti in ciascun braccio con recidiva post-trattamento.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a) 12 weeks after last dose of study drug;
b) up to 16 weeks after first dose of study drug
c) within 12 weeks after the last dose of study drug |
a) 12 settimane dopo l’ultima dose di farmaco in studio
b) fino a 16 settimane dopo l'ultima dose del farmaco in studio
c) entro 12 settimane dopo l'ultima dose del farmaco in studio
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Soglia basata sullo storico percentuale di SVR |
Threshold based on historical SVR rates |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 |
Canada |
European Union |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
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 | 1 |
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 |