Hepatitis C Rimantadine and Antiviral Combination Therapy (HepRiACT)
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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 |
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) |
-
Drug: rimantadine
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients with hepatitis c virus infection who are attending the department of hepatology for treatment with standard combination therpay
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| Contact: lynsey corless, mbchb phd | +441132067223 | lynsey.corless@nhs.net |
| Contact: stephen griffin, bsc phd | +44113 3438637 | s.d.c.griffin@leeds.ac.uk |
| 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 | |
| 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 May 23, 2013