Clinical Trial Results:
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.
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Summary
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EudraCT number |
2011-002781-21 |
Trial protocol |
GB |
Global end of trial date |
10 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Feb 2020
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First version publication date |
27 Feb 2020
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Other versions |
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Summary report(s) |
HepriaCT Final Report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CO11/9730
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Leeds Teaching Hospitals NHS Trust
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Sponsor organisation address |
St James University hospital , Leeds, United Kingdom, LS9 7TF
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Public contact |
Lynsey Corless, Leeds Teaching Hospitals, 0775 3682468, lynsey.corless@nhs.net
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Scientific contact |
Lynsey Corless, Leeds Teaching Hospitals, 0775 3682468, lynsey.corless@nhs.net
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Jun 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jun 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary aim of the study is to determine whether rimantadine (a drug developed and used for the treatment of Influenza A infection) has antiviral effects on hepatitis C virus (HCV).
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Protection of trial subjects |
All information collected during the course of the trial will be kept strictly confidential.Information will be held securely for the duration of the study.Patients with HCV attending the Hepatology clinic for assessment who meet the basic trial inclusion criteria will be given a verbal explanation of the trial. Those who express an interest in participating will be provided with a patient information sheet by a clinician. This will include detailed information about the rationale, design and personal implications of the study. Patients who do not have English as a first language will be offered a patient information sheet in their preferred language. Following information provision, patients will have at least 24 hours to consider participation and will be given the opportunity to discuss the trial with their family and healthcare professionals before they are asked whether they would be willing to take part in the trial. During the initial clinic visit, those who have expressed an interest in the trial will be asked to give permission for trial staff to contact them by phone to answer any remaining questions and to enquire if they wish to participate. This process will be clearly documented into the patient’s medical notes.Assenting patients will then be formally assessed for eligibility and invited to provide informed, written consent. The right of the patient to refuse consent without giving reasons will be respected. Further, the patient will remain free to withdraw from the study at any time without giving reasons and without prejudicing any further treatment. A copy of the consent will be given to the patient, one filed in the trial master file, one filed in the hospital notes and a fourth copy sent to the Sponsor.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Jul 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
8
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
8
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients screened as per the recruitment criteria. Assenting patients will then be formally assessed for eligibility and invited to provide informed, written consent. The right of the patient to refuse consent without giving reasons will be respected. | |||||||||
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Pre-assignment
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Screening details |
Patients with HCV attending the Hepatology clinic for assessment who meet the basic trial inclusion criteria will be given a verbal explanation of the trial. Those who express an interest in participating will be provided with a patient information sheet by a clinician.This will include detailed information about the study. | |||||||||
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Period 1
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Period 1 title |
Main Trial Period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
N/A
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Baseline Arm | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
rimantadine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Rimantadine hydrochloride is supplied in 50 mg film-coated tablets, intended for oral administration and tablets are stored at room temperature.
Rimantadine will be provided to the Chief Investigators in tablet form by the hospital pharmacy. Labels will indicate the product, lot number and dose.
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Arm title
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End Data | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
rimantadine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Rimantadine hydrochloride is supplied in 50 mg film-coated tablets, intended for oral administration and tablets are stored at room temperature.
Rimantadine will be provided to the Chief Investigators in tablet form by the hospital pharmacy. Labels will indicate the product, lot number and dose.
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Baseline characteristics reporting groups
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Reporting group title |
Main Trial Period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Baseline Arm
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Reporting group description |
- | ||
Reporting group title |
End Data
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Reporting group description |
- | ||
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End point title |
Detection of genomic sequence alterations in patients receiving rimantadine. [1] | |||||||||
End point description |
The primary objective of the study is to determine whether the addition of rimantadine therapy leads to alterations in HCV genomic sequences. This would provide evidence that rimantadine exerts a true antiviral effect on HCV and could lead to larger trials, assessing whether rimantadine therapy had a statistically significant effect on treatment response. Improvements in treatment response will correlate with a reduction in the prevalence of chronic HCV infection and a consequent reduction in cases of liver failure and hepatocellular carcinoma.
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End point type |
Primary
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End point timeframe |
Patients exposed to treatment for 48 weeks
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The study is descriptive in nature and is not designed to provide analytical results regarding treatment response. The sample size is based on clinical and regulatory considerations and has no formal statistical basis. Please see attached Summary report |
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Attachments |
Untitled (Filename: 9730_EndOfTrialSummaryReport_signed_150517.pdf) |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
SAEs will be collected for all patients and will be evaluated for duration and intensity.
SAEs will be collected for all patients from the first dose of rimantadine until 30 days after the last dose of treatment with rimantadine.
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Adverse event reporting additional description |
Information about AEs, whether volunteered by the patient, discovered by the investigator through questioning or detected through physical examination, laboratory test or other investigation will be collected and recorded in the patient filecard and trial masterfile. A copy of all reported AEs will be sent to the sponsor if requested.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17.0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Adverse event data can be requested from the scientific contact for the study, if required. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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05 Jul 2012 |
Patient information leaflet and Protocol amended to increase recruitment catchment and remove control group from the trial as recruitment was slower than expected. |
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29 Oct 2012 |
Amendment to the REC to include a patient information flyer, as clinical staff felt entire patient information sheet may be overwhelming to patients as the first introduction to the trial. Protocol Amended to include reference to leaflet |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None | |||
