Hepatitis CPhase 1NCT00314054
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
A Phase 1 study testing HCV-796 in people with Hepatitis C and Hepatic Insufficiency, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Hepatic Insufficiency
- What is being tested?
- HCV-796
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2006to Oct 2007
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women of non-childbearing potential.
- Hepatic impairment subjects: Child-Pugh class A, B, or C according to the C-P classification based on history, physical examination, and laboratory test results.
- Healthy volunteers: healthy as determined by the investigator.
Who cannot join
- History of alcoholism within 1 year.
- Hepatic impairment subjects: evidence of unstable clinically significant disease other than impaired hepatic function.
- Healthy volunteers: positive serologic findings for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Gainesville, Florida, 32608
Study site
Orlando, Florida, 32809
Study site
Saint Paul, Minnesota, 55114
About this study
Official title: An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of HCV-796 in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.
- Conditions
- Hepatitis C, Hepatic Insufficiency
- Being tested
- HCV-796
- Keywords
- Hepatitis C, Hepatic Impairment, Healthy Volunteer, Phase 1, Hepacivirus
- Medical subject headings
- Hepatitis C, Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV-796Drug
HCV-796 1000mg single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HCV-796 1000mg single dose Receives: Drug: HCV-796 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults
Measured: 7 days
Secondary outcomes (1)
To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2007
- Study completionOct 2007
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.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ViroPharma
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314054
- Sponsor's protocol ID
- 3173A1-105
- Status last verified
- Apr 2008
- First submitted
- 10 Apr 2006
- Last updated
- 14 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of HCV-796 in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
- ClinicalTrials.gov ID
- NCT00314054
- Acronym / sponsor ID
- 3173A1-105
- Conditions
- Hepatitis C, Hepatic Insufficiency
- Keywords
- Hepatitis C, Hepatic Impairment, Healthy Volunteer, Phase 1, Hepacivirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- ViroPharma
- Study start
- May 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 Apr 2006 (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.
The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HCV-796HCV-796 1000mg single dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women of non-childbearing potential.
- Hepatic impairment subjects: Child-Pugh class A, B, or C according to the C-P classification based on history, physical examination, and laboratory test results.
- Healthy volunteers: healthy as determined by the investigator.
Key exclusion criteria (3 listed)
- History of alcoholism within 1 year.
- Hepatic impairment subjects: evidence of unstable clinically significant disease other than impaired hepatic function.
- Healthy volunteers: positive serologic findings for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCV-796HCV-796 1000mg single dose | Drug | 1 |
Primary outcome
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults
Time frame: 7 days
1 secondary outcome
To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2008.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCV-796 in people with Hepatitis C and Hepatic Insufficiency, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites 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 3 inclusion and 3 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 14 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess PK in subjects with chronic hepatic impairment and in matched healthy adults (time frame: 7 days). 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 14 Apr 2008.