Hepatitis C Rimantadine and Antiviral Combination Therapy

NCT01413490 | Completed DMC

• 1 other identifier: 2011-002781-21
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

hepatitis C virus; Interferon; rimantadine; liver

Interventions

rimantadine DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead
• Cancer Research UK: collaborator

Study Sites (1)

St James University Hospital

Leeds, West Yorkshire, ls97tf, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples of patients undegoing standard combination therpay for hepatits c virus infection

MeSH Terms

Conditions

Hepatitis C

Interventions

Rimantadine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cycloparaffins; Hydrocarbons, Alicyclic

Study Officials

• mark aldersley, mbbs phd

  national health service

  PRINCIPAL INVESTIGATOR

• lynsey corless, mbchb phd

  national health service

  PRINCIPAL INVESTIGATOR

• stephen griffin, bsc phd

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 10, 2011
• Study Start: May 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

GB (1)