Hepatitis C Rimantadine and Antiviral Combination Therapy

NCT ID: NCT01413490

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-03-31

Brief 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.

Conditions

Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

rimantadine

12 weeks of rimantadine therapy in addition to standard combination therapy with interferon and ribavirin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Lynsey Corless

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mark aldersley, mbbs phd

Role: PRINCIPAL_INVESTIGATOR

national health service

lynsey corless, mbchb phd

Role: PRINCIPAL_INVESTIGATOR

national health service

stephen griffin, bsc phd

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

St James University Hospital

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

2011-002781-21

Identifier Type: -

Identifier Source: org_study_id