Hepatitis C Rimantadine and Antiviral Combination Therapy

Hepatitis C Clinical Trial

— HepRiACT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413490
• Other study ID #: 2011-002781-21
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2011
• Last updated: March 30, 2015
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
United Kingdom	St James University Hospital	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust	Cancer Research UK

Country where clinical trial is conducted

United Kingdom,