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Telaprevir in Genotype 3 HCV

NCT02087111 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-01-05

No results posted yet for this study

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.

Conditions

  • Hepatitis C

Interventions

DRUG

Telaprevir

375 mg film coated tablets

DRUG

40 Kd Pegylated interferon alfa 2a

180 µg in pre-filled syringe for sub-cutaneous injection

DRUG

Ribavirin

200 mg tablets

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • Barts & The London NHS Trust

    collaborator OTHER

  • St George's Healthcare NHS Trust

    collaborator OTHER

  • Bradford Teaching Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • Nottingham University Hospitals NHS Trust

    collaborator OTHER

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Graham R Foster · Queen Mary University of London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-11-01
Completion
2016-11-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02087111 on ClinicalTrials.gov