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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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Hepatitis C

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

mark aldersley, mbbs phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

national health service

Authority:

United Kingdom: Research Ethics Committee

Study ID:

2011-002781-21

NCT ID:

NCT01413490

Start Date:

May 2012

Completion Date:

May 2017

Related Keywords:

  • Hepatitis C
  • hepatitis C virus
  • Interferon
  • rimantadine
  • liver
  • Hepatitis
  • Hepatitis A
  • Hepatitis C

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