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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

August 9, 2011
October 5, 2012
May 2012
May 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01413490 on ClinicalTrials.gov Archive Site
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Hepatitis C Rimantadine and Antiviral Combination Therapy
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

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

patients with hepatitis c virus infection who are attending the department of hepatology for treatment with standard combination therpay

Hepatitis C
Drug: rimantadine
12 weeks of rimantadine therapy in addition to standard combination therapy with interferon and ribavirin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22
May 2017
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
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
 
NCT01413490
2011-002781-21
Yes
Lynsey Corless, The Leeds Teaching Hospitals NHS Trust
The Leeds Teaching Hospitals NHS Trust
Cancer Research 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
The Leeds Teaching Hospitals NHS Trust
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP