Hepatitis CNCT01721265
3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
An observational study of Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will include subjects who participated in studies of Idenix anti-HCV DAAs.
Who may be able to join
- Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained
- Have participated in an Idenix-sponsored study of an Idenix DAA
- Received at least 3 consecutive days of DAA treatment in an Idenix-sponsored study
- Agreed to comply with the visit schedule and laboratory tests
Who cannot join
- Treatment with placebo only, in an Idenix sponsored study
- Antiviral treatment for HCV after participation in an Idenix sponsored study of an Idenix DAA
About this study
Official title: 3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study.
In this study, researchers will try to find answers to these questions:
- How much (if any) hepatitis C virus is in your blood after stopping your Idenix study drug?
- Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or similar drugs?
Read the detailed description
The data obtained from this study will be used to further understand the long-term efficacy of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix DAAs.
- Conditions
- Hepatitis C
- Keywords
- HCV, Hepatitis C, IDX184, IDX719
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Durability of Sustained viral response [SVR]
To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.
Measured: every 3 months
Secondary outcomes (1)
Kinetics of resistant variants
To describe the kinetics of resistant variants to Idenix direct acting antivirals (DAAs) by HCV RNA sequencing. The presence of each identified resistant variant in the viral population will be descriptively evaluated until the viral population consists entirely of wild-type virus or over a period of 3 years, whichever comes first.
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721265
- Sponsor's protocol ID
- 1894-009
- Other IDs
- IDX-03YF
- Status last verified
- Apr 2015
- First submitted
- 31 Oct 2012
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
- ClinicalTrials.gov ID
- NCT01721265
- Acronym / sponsor ID
- 1894-009
- Conditions
- Hepatitis C
- Keywords
- HCV, Hepatitis C, IDX184, IDX719
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study.
In this study, researchers will try to find answers to these questions:
- How much (if any) hepatitis C virus is in your blood after stopping your Idenix study drug?
- Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or similar drugs?
Detailed description
The data obtained from this study will be used to further understand the long-term efficacy of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix DAAs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will include subjects who participated in studies of Idenix anti-HCV DAAs.
Key inclusion criteria (4 listed)
- Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained
- Have participated in an Idenix-sponsored study of an Idenix DAA
- Received at least 3 consecutive days of DAA treatment in an Idenix-sponsored study
- Agreed to comply with the visit schedule and laboratory tests
Key exclusion criteria (2 listed)
- Treatment with placebo only, in an Idenix sponsored study
- Antiviral treatment for HCV after participation in an Idenix sponsored study of an Idenix DAA
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
Durability of Sustained viral response [SVR]
Time frame: every 3 months
To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.
1 secondary outcome
Kinetics of resistant variants
Time frame: every 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Merck Sharp & Dohme LLC.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early. Results are not available in the source record.
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?
Durability of Sustained viral response [SVR] (time frame: every 3 months). 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 16 Apr 2015.