E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C |
Epatite C cronica |
|
E.1.1.1 | Medical condition in easily understood language |
Epatite C cronica |
Chronic Hepatitis C |
|
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 compare rates of SVR12, defined as HCV RNA < LOQ (detectable or
undetectable) at follow-up Week 12, for genotype 1 patients treated
with either BMS-790052 or TVR in combination with pegIFNα-2a/RBV |
Comparare i tassi di SVR12, definita come HCV RNA < LOQ (rilevabile o non rilevabile) alla settimana di 12 follow-up post-trattamento, per i soggetti con genotipo 1 trattati con il farmaco sperimentale BMS-790052 o TVR in combinazione con PegINFα-2a/RBV. |
|
E.2.2 | Secondary objectives of the trial |
To compare the proportion of patients with :
• hemoglobin laboratory value < 10 g/dL during the first 12 weeks of
treatment;
• rash-related dermatologic "events of special interest" reported during
the first 12 weeks of treatment;
• HCV RNA undetectable at Week 12;
• HCV RNA undetectable at Week 4;
• HCV RNA undetectable at Weeks 4 and 12;
• SVR24, defined as HCV RNA < LOQ (detectable or undetectable) at
follow-up Week 24;
• SVR12 by IL28B rs12979860 SNP genotype. |
Comparare la proporzione dei soggetti con:
-un valore dell’ emoglobina < 10 g/dL durante le prime 12 settimane di trattamento;
- “eventi di particolare interesse” (EOSI) dermatologici correlati a eruzioni cutanee, riportati durante le 12 prime settimane di trattamento;
-HCV RNA non rilevabile alla settimana 12;
-HCV RNA non rilevabile alla settimana 4;
-HCV RNA non rilevabile alle settimane 4 e 12;
-una SVR24, definita come HCV RNA < LOQ (rilevabile o non rilevabile) alla settimana 24 di follow-up post trattamento;
-SVR12 a seconda del polimorfismo del nucleotide singolo rs12979860 (SNP) nel gene IL28B. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects chronically infected with HCV genotype 1
- HCV RNA viral load ≥ 10,000 IU/mL
- No prior treatment including but not limited to interferon, ribavirin and
direct-acting antivirals
- if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan
within 1 year
- Body Mass Index (BMI) of 18 to 35 kg/m²
- Negative for HIV and Hepatitis B |
- soggetti cronicamente infetti daHCV Genotipo 1;
-HCV RNA ≥10,000 IU/mL;
-Nessun precedente trattamento per l’ HCV incluso ma non limitato a interferone, ribavirina o agenti antivirali ad azione diretta
-Se nessuna storia precedente di cirrosi, biopsia epatica entro 3 anni, o Fibroscan entro 1 anno
-Indice di massa corporea (BMI) da 18 a 35 kg/m²
-negatività per HIV ed epatite B |
|
E.4 | Principal exclusion criteria |
- Evidence of decompensated liver disease
- Evidence of medical condition contributing to chronic liver disease
other than HCV |
-Evidenze di malattia epatica scompensata
-Evidenze di una condizione medica che contribuisca alla malattia epatica cronica diversa da HCV |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with SVR12, defined as HCV RNA less than limit of
quantitation at follow-up Week 12 in each group |
Proporzione dei soggetti con SVR12, definita come la quantità di HCV RNA al di sotto del limite di quantificazione alla settimana 12 di follow-up in ciasscuna coorte |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Follow-up Week 12 |
settimana 12 di follow-up |
|
E.5.2 | Secondary end point(s) |
Proportion of patients with
1) hemoglobin value less than 10 g/dL
2) rash events
3) HCV RNA undetectable Week 12
4) HCV RNA undetectable Week 4
5) HCV RNA undetectable Weeks 4 and 12
6) SVR24
7) SVR12 based on IL28B genotype |
Proporzione dei soggetti con:
1. valore dell’emoglobina <10 g/dL
2. eruzioni cutanee
3. HCV RNA non rilevabile alla settimana 12;
4. HCV RNA non rilevabile alla settimana 4;
5. HCV RNA non rilevabile alle settimane 4 e 12;
6. SVR24
7. SVR12 a seconda del polimorfismo del nucleotide singolo rs12979860 (SNP) nel gene IL28B |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Proportion of patients with
1) hemoglobin value less than 10 g/dL
2) rash events
3) HCV RNA undetectable Week 12
4) HCV RNA undetectable Week 4
5) HCV RNA undetectable Weeks 4 and 12
6) SVR24
7) SVR12 based on IL28B genotype |
1. Fino alla settimana 12
2. Fino alla settimana 12
3. settimana 12
4. settimana 4
5. settimana 4 e 12
6. settimana 24 di follow-up
7. settimana 12 di follow-up |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker Assessments; Virologic Resistance Testing; Serum IP-10 Assessment and Healthcare Resource |
anal dei marcatori biol, test sulla resisit virale, anal dell'IP-10 e anal dell'uso risorsesanitarie |
|
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
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 |
Brazil |
Canada |
Israel |
Russian Federation |
Switzerland |
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
|
LPLV |
LPLV: ULTIMA VISITA DELL’ULTIMO SOGGETTO |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 28 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 28 |
E.8.9.2 | In all countries concerned by the trial days | 0 |