A clinical study to evaluate the effect of rimantadine in patients with hepatitis C virus (HCV) infection alongside standard treatment with pegylated interferon and ribavirin.

Phase 1

• Conditions: Hepatitis C Virus infection - genotype 1. Genotype 1 is least responsive to current treatment and is the focus of this study. HCV can cause severe liver damage - this study will only recruit those with no evidence of severe disease (i.e. no cirrhosis).; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002781-21-GB
• Lead Sponsor: eeds Teaching Hospitals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

Each patient MUST: • Have a diagnosis of HCV infection, genotype 1 • 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

No patient may: • Have dementia or altered mental status that would prohibit informed consent. • 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 • Any condition which would preclude the use of rimantadine. This comprises cirrhosis or liver failure (specific criteria for diagnosis are detailed in the research protocol), significant renal impairment, 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 Investigator, would make the patient inappropriate for this study. This includes the presence of end stage liver disease (i.e. cirrhosis).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified