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Hepatitis C Rimantadine and Antiviral Combination Therapy

Information source: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: rimantadine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: The Leeds Teaching Hospitals NHS Trust

Official(s) and/or principal investigator(s):
mark aldersley, mbbs phd, Principal Investigator, Affiliation: national health service
lynsey corless, mbchb phd, Principal Investigator, Affiliation: national health service
stephen griffin, bsc phd, Principal Investigator, Affiliation: University of Leeds

Summary

Hepatitis C virus is one of the leading causes of liver failure and liver cancer worldwide. Current treatment of hepatitis C infection is only successful in about half of those who are eligible. The current treatment aims to boost the host immune system but does not directly act on the virus. Many drugs are in various stages of development that target the virus

directly - their specific mode of action is confirmed by showing the virus is forced to

adapt in the presence of the drug. As with many viruses, treating with only one specific drug would quickly lead to the virus adapting and becoming resistant. We therefore need to find new combinations of directly acting drugs. Rimantadine has already been shown in the laboratory to target hepatitis C directly. We have designed this study to see if it happens in real life as well. If so, we could use rimantadine to help fight hepatitis c more effectively.

Clinical Details

Official title: A Clinical Study to Evaluate the Biological Effects of Administering Rimantadine in Patients With Hepatitis C Virus (HCV) Infection Alongside Standard Combination Therapy With Pegylated Interferon and Ribavirin

Study design: Observational Model: Cohort, Time Perspective: Prospective

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have a diagnosis of HCV infection, genotype 1 or genotype 3

- Be eligible for standard combination therapy with pegylated IFN and ribavirin

- Be at least 18 but no more than 65 years of age

- Have signed an informed consent indicating that the patient is aware of the

infectious nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts

- Be willing and able to comply with scheduled visits, the treatment plan, and

laboratory tests

- Have no contraindications to receiving rimantadine therapy

- Have blood results within defined acceptable haematological and biochemical

parameters (haemoglobin >10 g/dl, platelet count >150 x 109/L, bilirubin <25 umol/L, albumin >35 g/L, creatinine <150 umol/L Exclusion Criteria:

- Have dementia or altered mental status that would prohibit informed consent

- Have previously received treatment for HCV infection (i. e. are currently treatment

naïve)

- Have any condition which would deem the patient ineligible for combination therapy

with pegylated IFN or ribavirin. This includes pregnancy, significant cardiac, renal or autoimmune disease, severe depression or psychosis, and previous organ transplantation

- Cirrhosis or liver failure as evidenced by clinical (cutaneous stigmata of chronic

liver disease, ascites, encephalopathy), ultrasonic (cirrhotic appearance of liver, ascites) or biochemical (platelet count >150 x 109/L, bilirubin <25 umol/L, albumin >35 g/L) evidence, routinely collated in all patients diagnosed with HCV

- Any condition which would preclude the use of rimantadine. This comprises significant

renal impairment (creatinine >150), pregnancy, epilepsy or history of unexplained seizures

- Have any other severe, acute, or chronic medical or psychiatric condition or

laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Chief Investigators, would make the patient inappropriate for this study. This includes the presence of end stage liver disease (cirrhosis), and HIV infection

Locations and Contacts

St James University Hospital, Leeds, West Yorkshire ls97tf, United Kingdom
Additional Information

Starting date: May 2012
Last updated: March 30, 2015

Page last updated: August 20, 2015

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