Hepatitis C Rimantadine and Antiviral Combination Therapy (HepRiACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by The Leeds Teaching Hospitals NHS Trust
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Lynsey Corless, The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01413490
First received: August 9, 2011
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Hepatitis C
Drug: rimantadine
Phase 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Leeds Teaching Hospitals NHS Trust:

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 22
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rimantadine
    12 weeks of rimantadine therapy in addition to standard combination therapy with interferon and ribavirin
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413490

Contacts
Contact: lynsey corless, mbchb phd +441132067223 lynsey.corless@nhs.net
Contact: stephen griffin, bsc phd +44113 3438637 s.d.c.griffin@leeds.ac.uk

Locations
United Kingdom
St James University Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, ls97tf
Contact: Lynsey Corless, MBChB, PhD    44 113 2067223    lynsey.corless@nhs.net   
Contact: Mark Aldersley, MBBS, PhD    44 113 2067223    mark.aldersley@leedsth.nhs.uk   
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
Cancer Research UK
Investigators
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

No publications provided

Responsible Party: Lynsey Corless, doctor, The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01413490     History of Changes
Other Study ID Numbers: 2011-002781-21
Study First Received: August 9, 2011
Last Updated: October 5, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service

Keywords provided by The Leeds Teaching Hospitals NHS Trust:
hepatitis C virus
Interferon
rimantadine
liver

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Rimantadine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014