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Telaprevir in Genotype 3 HCV (TIG3)

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ClinicalTrials.gov Identifier: NCT02087111
Recruitment Status : Unknown
Verified July 2014 by Queen Mary University of London.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Collaborators:
Janssen-Cilag Ltd.
Barts & The London NHS Trust
St George's Healthcare NHS Trust
Bradford Teaching Hospitals NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Information provided by (Responsible Party):
Queen Mary University of London

Brief Summary:
Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very high chance of developing fatal complications of their disease unless they receive effective treatment. Unfortunately the best drugs that are currently available to treat genotype 3 hepatitis C (pegylated interferon and ribavirin) only work in about 50% of patients with advanced liver disease and therefore a large number of patients who have failed treatment are waiting for new, better drugs. Currently there are no treatments available for these patients. Telaprevir is a new drug that is licensed to treat genotype 1 hepatitis C and which works very well in these patients. In patients with genotype 3 hepatitis C small scale trials and laboratory studies show that some patients do respond quite well and others respond a little bit when given telaprevir. In patients who have exhausted all other treatment options the investigators speculate that telaprevir treatment may help some patients by clearing their infection. The purpose of this study is to see if telaprevir can help these patients and to determine if the investigators can predict in advance which people can be helped.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Telaprevir Drug: 40 Kd Pegylated interferon alfa 2a Drug: Ribavirin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telaprevir in Patients With Genotype 3 HCV: Pilot Clinical Study to Evaluate Efficacy and Predictability of Therapy in Patients Who Have Failed to Respond to Pegylated Interferon and Ribavirin
Study Start Date : April 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
All patients who are fulfil the entry criteria are treated for 24 weeks with 40 Kd Pegylated interferon alfa 2a, Ribavirin and 12 weeks with telaprevir.
Drug: Telaprevir
375 mg film coated tablets
Other Name: INCIVO

Drug: 40 Kd Pegylated interferon alfa 2a
180 µg in pre-filled syringe for sub-cutaneous injection
Other Name: Pegasys

Drug: Ribavirin
200 mg tablets
Other Name: Copegus




Primary Outcome Measures :
  1. Sustained virological response (SVR) 12 weeks after end of treatment (SVR12) [ Time Frame: Week 36 ]
    To determine whether patients with genotype 3 HCV and cirrhosis who have relapsed following therapy with PegIFN and RBV will achieve a sustained virological response (SVR) if treated with telaprevir, PegIFN and RBV


Secondary Outcome Measures :
  1. Response rate prediction [ Time Frame: By week 12 ]
    The proportion of patients who are phenotypically poorly responsive to telaprevir (defined as virus with a poor response to telaprevir in vitro i.e. an IC50 of <0.1microMol in an in vitro assay) who achieve early and late virological clearance.

  2. Sustained virological response 24 weeks after end of treatment. [ Time Frame: week 48 ]
    The proportion of patients with a sustained virological response 24 weeks after the last dose of PegIFN and RBV (SVR24). SVR 24 is defined as undetectable HCV RNA on a blood sample taken between 24 and 30 weeks after the final dose of PegIFN and ribavirin measured using a sensitive, validated polymerase chain reaction (PCR) assay with a lower limit of quantification of at least 30IU/ml.

  3. Treatment Success [ Time Frame: After week 48 ]
    The proportion of patients who have undetectable HCV RNA (measured using a sensitive, validated polymerase chain reaction (PCR) assay with a lower limit of quantification of at least 30IU/ml) after 1,2,3 and 4 weeks of therapy with PegIFN, RBV and telaprevir.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years of age and ≤ 70 years old
  • Advanced fibrosis - defined as a liver biopsy within 2 years showing an Ishak fibrosis score of >4 OR radiological 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 >50,000 cells/mm3 (support with eltrombopag is permitted) Neutrophil count > 600 cells/mm3
  • All female patients of childbearing potential and all males with female partners of childbearing potential must be prepared to 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

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
  • Evidence of ascites seen on previous liver ultrasound
  • 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
  • Albumin levels <35 G/L
  • 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 that, in the investigators opinion, precludes therapy
  • History of major organ transplantation with an existing functional graft
  • History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months
  • History or laboratory testing showing evidence of a haemoglobinopathy
  • Concomitant administration with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These active substances include alfuzosin, amiodarone, bepridil, quinidine, astemizole, terfenadine, cisapride, pimozide, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), lovastatin, simvastatin, atorvastatin, sildenafil or tadalafil (only when used for treatment of pulmonary arterial hypertension) and orally administered midazolam or triazolam.
  • Concomitant administration with Class Ia or III antiarrhythmics, except for intravenous lidocaine (see section 4.5).
  • Concomitant administration of INCIVO with active substances that strongly induce CYP3A e.g. rifampicin, St John's wort (Hypericum perforatum), carbamazepine, phenytoin and phenobarbital and thus may lead to lower exposure and loss of efficacy of INCIVO.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087111


Contacts
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Contact: Graham R Foster 02078827242 g.r.foster@qmul.ac.uk
Contact: Sampath DeSilva sampath81@doctors.org.uk

Locations
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United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust Not yet recruiting
Bradford, United Kingdom, BD9 6RJ
Contact: Sulleman Moreea       Sulleman.Moreea@bthft.nhs.uk   
Principal Investigator: Sulleman Moreea         
Barts Health NHS Trust Not yet recruiting
London, United Kingdom, E1 1BB
Contact: Graham R Foster    02078827242    g.r.foster@qmul.ac.uk   
Contact: Sampath DeSilva       sampath81@doctors.org.uk   
Principal Investigator: Graham R Foster         
Sub-Investigator: Sampath DeSilva         
Ste Georges Healthcare NHS Trust Not yet recruiting
London, United Kingdom, SW17 0QT
Contact: Daniel Forton       daniel.forton@nhs.net   
Principal Investigator: Daniel Forton         
Nottingham University Hospitals Trust Not yet recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Stephen Ryder       Stephen.Ryder@nuh.nhs.uk   
Principal Investigator: Stephen Ryder         
Sponsors and Collaborators
Queen Mary University of London
Janssen-Cilag Ltd.
Barts & The London NHS Trust
St George's Healthcare NHS Trust
Bradford Teaching Hospitals NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Investigators
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Principal Investigator: Graham R Foster Queen Mary University of London

Publications:

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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT02087111     History of Changes
Other Study ID Numbers: 9132
2013-003729-27 ( EudraCT Number )
13/LO/1473 ( Other Identifier: Health Research Authority )
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Keywords provided by Queen Mary University of London:
Telaprevir
Genotype 3 HCV
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Interferons
Ribavirin
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs