Hepatitis CNCT00674492
Hepatitis C Virus (HCV) Treatment Completion or Withdrawal
An observational study of Hepatitis C, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Aug 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: VHA patients who ever initiated antiviral treatment for hepatitis C.
Who may be able to join
- Ever initiated anitiviral treatment for hepatitis C.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
Official title: Patients' View of Hepatitis C Treatment Completion or Withdrawal
Qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis C.
Read the detailed description
Qualitative pilot study of patient' views of their experiences with antiviral treatment for hepatitis C. Two groups of patients will be sampled: nine who completed a 24 or 48 week course of treatment and nine who withdrew from treatment prior to planned end. Interview data will be analyzed using narrative and grounded theory methods to identify attributes of treatment experience that may discriminate between completion and withdrawal.
- Conditions
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis C patients | patients who initiated antiviral treatment for hepatitis C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attributes of Treatment Experience
Four basic reasons for persisting in antiviral treatment were identified: cure the disease, concern about diminishing time to act (avoid bad end), demonstation of personal strength, and redemption for past behavior.
Measured: Zero to five years since ending treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jack A Clark, PhD, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674492
- Sponsor's protocol ID
- SHP 08-193
- Status last verified
- Apr 2015
- First submitted
- 6 May 2008
- Last updated
- 15 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' View of Hepatitis C Treatment Completion or Withdrawal
- ClinicalTrials.gov ID
- NCT00674492
- Acronym / sponsor ID
- SHP 08-193
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Posted 9 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis C.
Detailed description
Qualitative pilot study of patient' views of their experiences with antiviral treatment for hepatitis C. Two groups of patients will be sampled: nine who completed a 24 or 48 week course of treatment and nine who withdrew from treatment prior to planned end. Interview data will be analyzed using narrative and grounded theory methods to identify attributes of treatment experience that may discriminate between completion and withdrawal.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C patients | – | –patients who initiated antiviral treatment for hepatitis C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- VHA patients who ever initiated antiviral treatment for hepatitis C.
Key inclusion criteria (1 listed)
- Ever initiated anitiviral treatment for hepatitis C.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attributes of Treatment Experience
Time frame: Zero to five years since ending treatment.
Four basic reasons for persisting in antiviral treatment were identified: cure the disease, concern about diminishing time to act (avoid bad end), demonstation of personal strength, and redemption for past behavior.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack A Clark, PhD principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attributes of Treatment Experience (time frame: Zero to five years since ending treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.