Status:
COMPLETED
Hepatitis C Rimantadine and Antiviral Combination Therapy
Lead Sponsor:
The Leeds Teaching Hospitals NHS Trust
Collaborating Sponsors:
Cancer Research UK
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01413490
Start Date
May 1 2012
End Date
March 1 2015
Last Update
March 31 2015
Active Locations (1)
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1
St James University Hospital
Leeds, West Yorkshire, United Kingdom, ls97tf