Genotype 3 HCV
Conditions
Interventions
Trade Name: INCIVO
Product Name: INCIVO
Pharmaceutical Form: Film-coated tablet
CAS Number: 402957-28-2
Other descriptive name: TELAPREVIR
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with genotype 3 HCV and advanced fibrosis - defined as a liver biopsy within 2 years showing an Ishak fibrosis score of >4 OR rdiological evidence of cirrhosis (ultrasound scan or fibroscan reading >10.6) Previous therapy with pegylated interferon and ribavirin for at least 24 weeks with undetectable HCV RNA at the end of therapy and detectable HCV RNA six months after treatment cessation Chronic genotype 3 HCV infection, RNA positivity with genotype 3 infection confirmed at a local laboratory. HBsAg negative and no clinical evidence of co-infection with HIV Platelet count >20,000 cells/mm3, Neutrophil count > 600 cells/mm3 Negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end • Able and willing to give informed consent and able to comply with study requirements Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Evidence of other cause of significant liver disease – serum ferritin > 1000, biochemical evidence of Wilson’s disease, autoantibody titres in excess of 1:160 Poorly controlled diabetes that, in the investigators opinion, precludes therapy Severe retinopathy that, in the opinion of the investigator, precludes therapy Ascites Haemoglobin concentration 10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management Other on-going serious medical condition in the opinion of the investigator that would prohibit treatment Poorly controlled thyroid dysfunction History of major organ transplantation with an existing functional graft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Proportion of patients treated with telaprevir who achieve a sustained virolgical response;Timepoint(s) of evaluation of this end point: 24 weeks after last dose of medication;Main Objective: Do patients with genotype 3 hepatitis C and cirrhosis who have failed to respond to pegylated interferon and ribavirin respond to retreatment with pegylated interferon, ribavirin and telaprevir? Does pre-treatment viral phenotyping identify patients who respond to pegylated interferon, ribavirin and telaprevir?;Secondary Objective: What are the side effects of therapy with pegylated interferon/ribavirin and telaprevir in a cohort of patients with genotype 3 HCV and cirrhosis? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Does pre-treatment phenotyping of hepatitis C allow us to identify which patients will respond to pegylated interferon, ribavirin and telaprevir;Timepoint(s) of evaluation of this end point: 28 weeks after last dose of medication | — |
Countries
United Kingdom
Contacts
Public ContactFoster
Queen Marys School of Medicine
Outcome results
None listed