Clinical trial NCT01413490: Hepatitis C Rimantadine and Antiviral Combination Therapy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: hepatitis C virus
Interferon
rimantadine
liver
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2011-08-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hepatitis c virus infection who are attending the department of hepatology for treatment with standard combination therpay

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: St James University Hospital
state: West Yorkshire
Study officials:
affiliation: national health service
name: mark aldersley, mbbs phd
role: PRINCIPAL_INVESTIGATOR
affiliation: national health service
name: lynsey corless, mbchb phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leeds
name: stephen griffin, bsc phd
role: PRINCIPAL_INVESTIGATOR
References: