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Hepatitis C Rimantadine and Antiviral Combination Therapy (HepRiACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01413490
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : March 31, 2015
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Lynsey Corless, The Leeds Teaching Hospitals NHS Trust

Study Description
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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.

Condition or disease Intervention/treatment
Hepatitis C Drug: rimantadine

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : May 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Biospecimen Retention:   Samples Without DNA
blood samples of patients undegoing standard combination therpay for hepatits c virus infection

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413490


Locations
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United Kingdom
St James University Hospital
Leeds, West Yorkshire, United Kingdom, ls97tf
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
Cancer Research UK
Investigators
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Principal Investigator: 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
More Information
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Responsible Party: Lynsey Corless, doctor, The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01413490    
Other Study ID Numbers: 2011-002781-21
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Lynsey Corless, The Leeds Teaching Hospitals NHS Trust:
hepatitis C virus
Interferon
rimantadine
liver
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Rimantadine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action