Reinfection and Long Term Outcomes in Intravenous Drug Users (IVDUs) After Hepatitis C Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Pennine Acute Hospitals NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Pennine Acute Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01329952
First received: April 4, 2011
Last updated: April 5, 2011
Last verified: March 2011
  Purpose

The investigators will identify possible participants using our database of previously treated hepatitis c patients. The investigators will identify those who have documented evidence of current injecting drug use as a risk factor for acquisition of the virus. The investigators will then search for those who have received curative treatment between 2004-2010. This covers all patients in the current database. The investigators will include those over 18 years old. The investigators will exclude those patients who are coinfected with either hepatitis B or HIV. This is because both of these conditions can accelerate liver damage when in combination with hepatitis c.

The possible participants identified will be sent an information sheet giving a simple and clear outline of the proposed research. The investigator will try to obtain an au to date residential address from the PAS system in the NHS or through confirmation from the patients GP or drug worker. It will explain the purpose of the study, why they have been chosen, what taking part will involve, the potential advantages and disadvantages of taking part and that everything will be kept confidential. It will also outline who is conducting the study, how any expenses will be paid and contact details for any problems/complaints that arise.

Those interested in taking part will attend an appointment at the hospital after they have had the opportunity to read through the information leaflet. They will be given time to ask any questions they have about the study and have them answered fully. They will then be asked to sign two copies of a consent form in order to take their participation any further. Once this is complete they can have their first 'liver assessment'. The assessment will take approximately 30-45 minutes to complete.

The investigators will take three blood samples from them (approximately 10mls of blood or 4 teaspoons full). One sample is to measure the levels of hepatitis C virus in the blood. This will tell us whether there has been reinfection with hepatitis C. The second sample is to measure the levels of inflammation within the liver and the third sample is to measure the full blood count. The investigators will then perform a liver scan called a fibroscan. This is a noninvasive test similar to an ultrasound (that pregnant women have) and gives a reading that can tell us about any 'stiffness' in the liver. It takes approximately five to ten minutes to complete and involves the patient lying on their back with their right arm above their head for the duration of the scan. Following the scan the investigators will ask the participant to complete a short questionnaire. This will include questions about past and current drug use as well as any alcohol use. The answers will be kept strictly confidential. They will be stored in the researchers locked office and have no direct participant identifiers on them. They will simply have a study number on them.The participant will then be thanked for their time and offered £30 to cover all travel and time expenses for their visit.

They will be invited to attend for a further liver assessment one year after their first one and annually thereafter. This is optional and they are of course free to withdraw from the study at any time without needing to give a reason.

The investigators will be identifying participants at different points in time following their curative treatment. For example some will have been cured 5 year ago whereas other will have been cured 6-12 months ago. This will increase the number of patient years follow up. Once the investigators have done the first set of liver assessment the participants will then be followed prospectively for as long as they wish to participate.

For the purpose of my higher degree I will present the data I have following two years of 'liver assessments'.


Condition
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Reinfection Rates and Long Term Outcomes in Currently Injecting Drug Users Following Successful Treatment for Hepatitis C

Resource links provided by NLM:


Further study details as provided by Pennine Acute Hospitals NHS Trust:

Primary Outcome Measures:
  • To determine the reinfection rates in a historical cohort of drug users with Hepatitis C genotype 3 who have been previously treated and cured. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    This will be calculated in terms of cases per 100 person years.


Secondary Outcome Measures:
  • To determine long term outcomes in those who injected drugs at the time of treatment and compare this to past injecting drug users. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Blood taken for HCV RNA +/- HCV genotype, liver function tests and full blood count. Annual fibroscans will be performed.


Biospecimen Retention:   Samples Without DNA

Blood will be taken for Hepatitis C RNA, plus Hepatitis C genotype if positive. Blood will also be taken for liver function tests and a full blood count.


Estimated Enrollment: 90
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Current intravenous drug users
Those who were actively injecting drugs at the time of their hepatitis C treatment.
Past drug users
Those who stopped injecting drugs intravenously at least 6 months prior to the start of treatment for hepatitis C

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This will focus specifically on long term outcomes for patients who are current and past injecting drug users at the time of their treatment. Injecting drug users who have already completed therapy and achieved SVR will be asked to return for assessment. During this study, the investigators will also enquire about any drug use prior to, during and after completing therapy. The investigators will compare this group with past injectors, (last injected at least 6 months prior to starting treatment) a group that most centres would consider appropriate for treatment).

Criteria

Inclusion criteria

  • Aged 18 years or older
  • Achieved cure (negative Hepatitis C pcr 6 months after completing treatment)
  • Previous history of injecting drug use
  • Previously infected with Hepatitis C

Exclusion criteria

  • Prison resident
  • Co-infection with HIV or chronic hepatitis B
  • Did not achieve cure with treatment for Hepatitis C
  • Pregnant females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329952

Contacts
Contact: Joanne M Baxter, MBChB 0161 7202060 joanne.baxter@pat.nhs.uk
Contact: Javier Vilar, LMS, MD 0161 7203097 javi.vilar@pat.nhs.uk

Locations
United Kingdom
North Manchester General Hospital
Manchester, Greater Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Pennine Acute Hospitals NHS Trust
Roche Pharma AG
Investigators
Principal Investigator: Joanne M Baxter, MBChB North Manchester General Hospital
  More Information

No publications provided

Responsible Party: Dr Joanne Baxter, North Manchester General Hospital, Delauneys Road, Crumpsall, Manchester, M8 5RB
ClinicalTrials.gov Identifier: NCT01329952     History of Changes
Other Study ID Numbers: HCV-NMGH
Study First Received: April 4, 2011
Last Updated: April 5, 2011
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on July 22, 2014