HCV InfectionPhase 2NCT00978497
Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection
A Phase 2 study testing ANA598, Peginterferon and Ribavirin in people with HCV Infection, run by Hoffmann-La Roche at 21 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared to placebo + SOC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HCV Infection
- What is being tested?
- ANA598, Peginterferon and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Sep 2009to Aug 2011
- Phase
- Phase 2
- 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
Who cannot join
- Female patients who are pregnant or breast-feeding
- Infection with non-genotype 1 HCV
- Previous treatment for HCV infection
- HIV or HBV positive
- Any medical contraindication to Peg-IFN or RBV therapy
- History of any other known cause of liver disease
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
United States, California 1
Anaheim, California, 92801
United States, Massachusetts
Boston, Massachusetts, 02215
United States, North Carolina
Chapel Hill, North Carolina, 27514
United States, Ohio
Cincinnati, Ohio, 45267
United States, Michigan
Detroit, Michigan, 48202
United States, North Carolina
Durham, North Carolina, 27705
United States, Virginia 1
Fairfax, Virginia, 22031
United States, Virginia 2
Falls Church, Virginia, 22042
United States, Florida 2
Gainesville, Florida, 32601
United States, Texas 2
Houston, Texas, 77073
United States, California 4
Los Angeles, California, 90048
United States, Maryland
Lutherville, Maryland, 21093
United States, Florida 3
Miami, Florida, 33136
United States, New York
New York, New York, 10021
United States, Pennsylvania
Philadelphia, Pennsylvania, 19104
United States, Texas 1
San Antonio, Texas, 78215
United States, California 2
San Clemente, California, 92673
United States, California 3
San Diego, California, 92120
United States, California 5
San Francisco, California, 33136
United States, Florida 1
Sarasota, Florida, 34209
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of the Safety, Efficacy, and Pharmacokinetics of ANA598 Administered With Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients With Chronic Hepatitis C Infection
The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared to placebo + SOC.
Read the detailed description
The safety, tolerability and antiviral activity of ANA598, administered orally at 200 mg BID or 400 mg BID for 12 weeks in combination with pegylated interferon and ribavirin (SOC) will be compared to placebo + SOC. Treatment-naïve patients with genotype 1 infection will be eligible for enrollment. Patients randomized to ANA598 will receive a loading dose of 800 mg q 12 hours administered on the first day of dosing. Patients with undetectable HCV RNA at week 4 and week 12 will be randomized to receive either an additional 12 or 36 weeks of SOC alone.
Ninety patients will be randomized into 2 cohorts. The forty-five patients in each cohort will be randomized as 30 active: 15 placebo.
- Conditions
- HCV Infection
- Being tested
- placebo, ANA598, Peginterferon, Ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
oral BID
ANA598Drug
oral 200mg BID
ANA598Drug
oral 400mg BID
PeginterferonDrug
180 μg dose via subcutaneous injection weekly
RibavirinDrug
oral 1000 mg/day for patients who weighed < 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Peginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks Receives: Drug: placebo; Drug: Peginterferon; Drug: Ribavirin |
| 2 | Experimental | ANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks Receives: Drug: ANA598; Drug: Peginterferon; Drug: Ribavirin |
| 3 | Experimental | ANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks Receives: Drug: ANA598; Drug: Peginterferon; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HCV RNA
Measured: 12 Weeks
Secondary outcomes (4)
Safety and Tolerability
Measured: Throughout study
Undetectable HCV RNA
Measured: Week 4, Week 24, and Week 48
ANA598, Peg-IFN-a-2-a, ribavirin concentrations
Measured: Various time points through Week 12
Undetectable HCV RNA
Measured: 24 weeks after completion of therapy for sustained virologic response [SVR]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 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
- NCT00978497
- Sponsor's protocol ID
- ANA598-504
- Status last verified
- Mar 2017
- First submitted
- 16 Sep 2009
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Trial of the Safety, Efficacy, and Pharmacokinetics of ANA598 Administered With Pegylated Interferon and Ribavirin in Treatment-Naïve Genotype 1 Patients With Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT00978497
- Acronym / sponsor ID
- ANA598-504
- Conditions
- HCV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Sep 2009 (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 safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care [SOC]) compared to placebo + SOC.
Detailed description
The safety, tolerability and antiviral activity of ANA598, administered orally at 200 mg BID or 400 mg BID for 12 weeks in combination with pegylated interferon and ribavirin (SOC) will be compared to placebo + SOC. Treatment-naïve patients with genotype 1 infection will be eligible for enrollment. Patients randomized to ANA598 will receive a loading dose of 800 mg q 12 hours administered on the first day of dosing. Patients with undetectable HCV RNA at week 4 and week 12 will be randomized to receive either an additional 12 or 36 weeks of SOC alone.
Ninety patients will be randomized into 2 cohorts. The forty-five patients in each cohort will be randomized as 30 active: 15 placebo.
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 |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo, Drug: Peginterferon, Drug: RibavirinPeginterferon and ribavirin + placebo BID for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks |
| 2 | Experimental | Drug: ANA598, Drug: Peginterferon, Drug: RibavirinANA598 200 mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks |
| 3 | Experimental | Drug: ANA598, Drug: Peginterferon, Drug: RibavirinANA598 400mg BID + Peginterferon and ribavirin for 12 weeks, followed by Peg-IFN and RBV for an additional 12 or 36 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, ages 18 to 65 years
- Documented chronic HCV infection, genotype 1a or 1b
- Treatment-naïve
Key exclusion criteria (6 listed)
- Female patients who are pregnant or breast-feeding
- Infection with non-genotype 1 HCV
- Previous treatment for HCV infection
- HIV or HBV positive
- Any medical contraindication to Peg-IFN or RBV therapy
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 |
|---|---|---|
| placebooral BID | Drug | 1 |
| ANA598oral 200mg BID | Drug | 2 |
| ANA598oral 400mg BID | Drug | 3 |
| Peginterferon180 μg dose via subcutaneous injection weekly | Drug | 1, 2, 3 |
| Ribavirinoral 1000 mg/day for patients who weighed < 75 kg and 1200 mg/day for patients who weighed ≥ 75 kg | Drug | 1, 2, 3 |
Primary outcome
Undetectable HCV RNA
Time frame: 12 Weeks
4 secondary outcomes
Safety and Tolerability
Time frame: Throughout study
Undetectable HCV RNA
Time frame: Week 4, Week 24, and Week 48
ANA598, Peg-IFN-a-2-a, ribavirin concentrations
Time frame: Various time points through Week 12
Undetectable HCV RNA
Time frame: 24 weeks after completion of therapy for sustained virologic response [SVR]
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 31 Mar 2017.
Related trials for HCV Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
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.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANA598, Peginterferon and Ribavirin in people with HCV Infection, run by Hoffmann-La Roche at 21 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 3 inclusion and 6 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Undetectable HCV RNA (time frame: 12 Weeks). 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 31 Mar 2017.