Chronic Hepatitis CPhase 1NCT00782353
Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection
A Phase 1 study of Chronic Hepatitis C, run by Hoffmann-La Roche at 4 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2008to Mar 2009
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ages 18 to 65 years
- Documented chronic HCV infection, genotype 1a or 1b
- Treatment-naïve
- BMI = 18 - 35 kg/m2
Who cannot join
- Female patients who are pregnant or breast-feeding
- Previous treatment for HCV infection
- HIV or HBV positive
- Evidence of cirrhosis on previous liver biopsy or on previous imaging studies
- History of any other known cause of liver disease;
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
United States, New York
New York, New York, 10021
United States, Texas
San Antonio, Texas, 78215
United States, Missouri
St Louis, Missouri, 63104
About this study
Official title: A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection
The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.
Read the detailed description
The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.
- Conditions
- Chronic Hepatitis C
- Being tested
- ANA598 200 mg bid or placebo, ANA598 400 mg bid or placebo, ANA598 800 mg bid or placebo
- Keywords
- HCV
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANA598 200 mg bid or placeboDrug
ANA598 200 mg bid or placebo
ANA598 400 mg bid or placeboDrug
ANA598 400 mg bid or placebo
ANA598 800 mg bid or placeboDrug
ANA598 800 mg bid or placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid Receives: Drug: ANA598 200 mg bid or placebo |
| Cohort 2 | Experimental | Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid Receives: Drug: ANA598 400 mg bid or placebo |
| Cohort 3 | Experimental | Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid Receives: Drug: ANA598 800 mg bid or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease;
Measured: 10 days
The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782353
- Sponsor's protocol ID
- ANA598-502
- Status last verified
- Nov 2012
- First submitted
- 28 Oct 2008
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mallalieu NL, Rahimy MH, Crowley CA, Appleman JR, Smith PF, Freddo JL. Pharmacokinetics and pharmacodynamics of setrobuvir, an orally administered hepatitis C virus non-nucleoside analogue inhibitor. Clin Ther. 2014 Dec 1;36(12):2047-2063.e3. doi: 10.1016/j.clinthera.2014.10.002. Epub 2014 Nov 4.
PubMed 25456558
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT00782353
- Acronym / sponsor ID
- ANA598-502
- Conditions
- Chronic Hepatitis C
- Keywords
- HCV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 31 Oct 2008 (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 investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.
Detailed description
The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ANA598 200 mg bid or placeboSubjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid |
| Cohort 2 | Experimental | Drug: ANA598 400 mg bid or placeboSubjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid |
| Cohort 3 | Experimental | Drug: ANA598 800 mg bid or placeboSubjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, ages 18 to 65 years
- Documented chronic HCV infection, genotype 1a or 1b
- Treatment-naïve
- BMI = 18 - 35 kg/m2
Key exclusion criteria (5 listed)
- Female patients who are pregnant or breast-feeding
- Previous treatment for HCV infection
- HIV or HBV positive
- Evidence of cirrhosis on previous liver biopsy or on previous imaging studies
- History of any other known cause of liver disease;
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 |
|---|---|---|
| ANA598 200 mg bid or placeboANA598 200 mg bid or placebo | Drug | Cohort 1 |
| ANA598 400 mg bid or placeboANA598 400 mg bid or placebo | Drug | Cohort 2 |
| ANA598 800 mg bid or placeboANA598 800 mg bid or placebo | Drug | Cohort 3 |
Primary outcome
The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease;
Time frame: 10 days
The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels
Time frame: 10 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 Nov 2012.
- Derived from this study: PubMed 25456558Mallalieu NL, Rahimy MH, Crowley CA, Appleman JR, Smith PF, Freddo JL. Pharmacokinetics and pharmacodynamics of setrobuvir, an orally administered hepatitis C virus non-nucleoside analogue inhibitor. Clin Ther. 2014 Dec 1;36(12):2047-2063.e3. doi: 10.1016/j.clinthera.2014.10.002. Epub 2014 Nov 4.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Chronic Hepatitis C, run by Hoffmann-La Roche at 4 sites in 2 countries.
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 5 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 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Puerto Rico. 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?
The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease; (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00782353, which also lists 1 linked publication.
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 Nov 2012.