Genotype 3 Hepatitis C:Therapy with telaprevir

Phase 1

• Conditions: Genotype 3 HCV; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-003729-27-GB
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-18
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

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 <11 g/dL in females or <12 g/dL in males or any patient with an increased risk for anaemia (e.g., thalassemia, sickle cell anaemia, spherocytosis, history of gastrointestinal bleeding) or for whom anaemia would be medically problematic
Females who are pregnant or breast-feeding
History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease within the last 2 years
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis (defined as affecting >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?<br>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 Outcome Measures

Name	Time	Method
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