Hepatitis C, ChronicPhase 2NCT01903954
A Study of Setrobuvir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Genotype 1 Chronic Hepatitis C
A Phase 2 study testing peginterferon alfa-2a [Pegasys], ribavirin [Copegus] and setrobuvir in people with Hepatitis C, Chronic, run by Hoffmann-La Roche.
Trial summary
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) or placebo in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- peginterferon alfa-2a [Pegasys], ribavirin [Copegus] and setrobuvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 283 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to May 2013
- 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
- Adult patients, 18 to 65 years of age inclusive
- Documented chronic hepatitis C
- Treatment-naïve (no prior exposure to Pegasys, Copegus, or experimental HCV therapy) or treatment-experienced with current standard of care (Pegasys and Copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
- Serum HCV RNA >/= 50,000 IU/mL at screening
- HCV antibody positive at screening
- HCV genotype 1
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- Body mass index (BMI) 18-38 kg/m2
- In good health other than chronic HCV infection in the judgment of the principal investigators
- Negative for hepatitis B and HIV infection
Who cannot join
- Pregnant or breastfeeding women
- For treatment-naïve patients: any previous treatment for HCV infection
- For treatment-experienced patients: previous treatment with an experimental therapy for HCV infection
- Co-infection with HIV or hepatitis C virus (HBV)
- History or evidence of decompensated liver disease
- History or evidence of hepatocellular carcinoma
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- History of alcohol abuse and/or other drug addiction </= 1 year prior to enrollment in the study
- Poorly controlled diabetes mellitus
- One or more additional known primary causes of liver disease other than hepatitis C
- History of acute or chronic pancreatitis
- Participation in an other clinical study of a new chemical entity within 30 days prior to study randomization
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48 weeks depending on response. Treatment-experienced patients categorized as relapsers, partial responders and viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus for 48 weeks. Treatment-experienced patients categorized as null-responders to previous pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus Pegasys and Copegus for 48 weeks.
- Conditions
- Hepatitis C, Chronic
- Being tested
- peginterferon alfa-2a [Pegasys], placebo, ribavirin [Copegus], setrobuvir
- 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.
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc weekly
placeboDrug
Orally b.i.d.
ribavirin [Copegus]Drug
1000 mg or 1200 mg orally daily
setrobuvirDrug
Also called ANA598
Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: placebo; Drug: ribavirin [Copegus] |
| Setrobuvir | Experimental | Setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]; Drug: setrobuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving sustained virologic response (SVR24), defined as undetectable hepatitis C virus (HCV) RNA at 24 weeks after discontinuation of all study drugs
Measured: 24 weeks after discontinuation of all study drugs (treatment duration 28 or 48 weeks)
Secondary outcomes (3)
Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24
Measured: 24 weeks
Proportion of treatment-naïve patients eligible to stop all treatment at Week 28
Measured: 28 weeks
Safety: Incidence of adverse events
Measured: up to approximately 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903954
- Sponsor's protocol ID
- NP28302
- Status last verified
- Nov 2016
- First submitted
- 17 Jul 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype 1 Patients With Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT01903954
- Acronym / sponsor ID
- NP28302
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Jul 2013 (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.
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of setrobuvir in patients with genotype 1 chronic hepatitis C. Treatment-naïve patients will be randomized to receive either setrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) or placebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Treatment duration will be 28 weeks or 48 weeks depending on response. Treatment-experienced patients categorized as relapsers, partial responders and viral breakthrough patients to previous pegylated interferon and ribavirin therapy will be randomized to receive either setrobuvir or placebo in combination with Pegasys and Copegus for 48 weeks. Treatment-experienced patients categorized as null-responders to previous pegylated interferon and ribavirin therapy will be assigned to treatment with setrobuvir plus Pegasys and Copegus for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Drug: peginterferon alfa-2a [Pegasys], Drug: placebo, Drug: ribavirin [Copegus]Pplacebo in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) |
| Setrobuvir | Experimental | Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus], Drug: setrobuvirSetrobuvir (800 mg orally b.i.d loading dose followed by 200 mg orally .b.i.d.) in combination with standard of care Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients, 18 to 65 years of age inclusive
- Documented chronic hepatitis C
- Treatment-naïve (no prior exposure to Pegasys, Copegus, or experimental HCV therapy) or treatment-experienced with current standard of care (Pegasys and Copegus) but categorized as null-responder or patients with partial response, relapse or viral breakthrough during or following prior treatment
- Serum HCV RNA >/= 50,000 IU/mL at screening
- HCV antibody positive at screening
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women
- For treatment-naïve patients: any previous treatment for HCV infection
- For treatment-experienced patients: previous treatment with an experimental therapy for HCV infection
- Co-infection with HIV or hepatitis C virus (HBV)
- History or evidence of decompensated 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 |
|---|---|---|
| peginterferon alfa-2a [Pegasys]180 mcg sc weekly | Drug | Active Comparator, Setrobuvir |
| placeboOrally b.i.d. | Drug | Active Comparator |
| ribavirin [Copegus]1000 mg or 1200 mg orally daily | Drug | Active Comparator, Setrobuvir |
| setrobuvirAlso: ANA598Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks | Drug | Setrobuvir |
Primary outcome
Proportion of patients achieving sustained virologic response (SVR24), defined as undetectable hepatitis C virus (HCV) RNA at 24 weeks after discontinuation of all study drugs
Time frame: 24 weeks after discontinuation of all study drugs (treatment duration 28 or 48 weeks)
3 secondary outcomes
Proportion of patients achieving undetectable HCV RNA (defined as HCV RNA < 15 IU/mL) at each visit through Week 24
Time frame: 24 weeks
Proportion of treatment-naïve patients eligible to stop all treatment at Week 28
Time frame: 28 weeks
Safety: Incidence of adverse events
Time frame: up to approximately 72 weeks
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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peginterferon alfa-2a [Pegasys], ribavirin [Copegus] and setrobuvir in people with Hepatitis C, Chronic, run by Hoffmann-La Roche.
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 9 inclusion and 11 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 2 Nov 2016. 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.
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?
Proportion of patients achieving sustained virologic response (SVR24), defined as undetectable hepatitis C virus (HCV) RNA at 24 weeks after discontinuation of all study drugs (time frame: 24 weeks after discontinuation of all study drugs (treatment duration 28 or 48 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 2 Nov 2016.