Hepatitis C, ChronicPhase 2NCT01579019
A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C Genotype 1 Who Have Failed Prior HCV Protease Inhibitor Treatment
A Phase 2 study testing RO5024048, danoprevir and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche.
Trial summary
This randomized, double blind, phase II study will evaluate the efficacy and safety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease inhibitor containing regimen with or without pegylated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- RO5024048, danoprevir and peginterferon alfa-2a [Pegasys]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Mar 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, >/= 18 years of age
- Hepatitis C genotype 1 infection
- Serum HCV quantifiable by Roche COBAS TaqMan HCV Test v2.0
- Liver biopsy (within 24 months) or Fibroscan (within 12 months) before first administration of study drug consistent with chronic hepatitis C and demonstrating absence of liver cirrhosis
- Documented failed prior treatment with protease inhibitor (evidenced by viral breakthrough or partial response while on treatment or relapse after treatment), including documentation on treatment with other direct-acting antiviral agents and other HCV antiviral treatment
- Patients must have discontinued prior HCV treatment at least 24 weeks prior to first dose of study drug in this trial
Who cannot join
- Infection with any HCV genotype other than genotype 1
- Evidence of any variants associated with protease inhibitor resistance at screening
- Body mass index (BMI) <18 or >/=36 kg/m2
- Positive for hepatitis A or hepatitis B infection
- Use of any systemic antiviral therapy with perceived activity against HCV </=1 month prior to first dose of study drug
- History or evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
Show all 15Show fewer
- Pregnant or breastfeeding women
- Males with female partners who are pregnant
- History of immunologically mediated disease; patients with rheumatoid arthritis requiring only intermittent non-steroidal anti-inflammatory medications or with celiac disease will be allowed
- History or evidence of decompensated liver disease
- History or evidence of renal disease; patients with history of nephrolithiasis will be allowed
- Uncontrolled Type 1 or 2 diabetes
- History or evidence of chronic pulmonary disease associated with functional limitation
- History of severe cardiac disease History of any neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin (e.g. basal or squamous cell carcinoma)
- Evidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of the first dose of study drug
About this study
This randomized, double blind, phase II study will evaluate the efficacy and safety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease inhibitor containing regimen with or without pegylated interferon. Patients will be randomized to receive either a 2-week lead-in of RO5024048 (1500 mg or 1000 mg orally twice daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or 1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with danoprevir (100 mg orally twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on study treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.
- Conditions
- Hepatitis C, Chronic
- Being tested
- RO5024048, danoprevir, peginterferon alfa-2a [Pegasys], ribavirin [Copegus], ritonavir
- 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.
RO5024048Drug
1500 mg po bid, 24 or 26 weeks
RO5024048Drug
1000 mg po bid, 24 or 26 weeks
danoprevirDrug
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc qw, 24 or 26 weeks
ribavirin [Copegus]Drug
1000 mg or 1200 mg po daily, 24 or 26 weeks
ritonavirDrug
100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
| Study group | Role | What they receive |
|---|---|---|
| 1000 mg 24 weeks | Active comparator | Not described Receives: Drug: RO5024048; Drug: danoprevir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus] |
| 1000 mg 26 weeks | Active comparator | Not described Receives: Drug: RO5024048; Drug: danoprevir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]; Drug: ritonavir |
| 1500 mg 24 weeks | Experimental | Not described Receives: Drug: RO5024048; Drug: danoprevir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]; Drug: ritonavir |
| 1500 mg 26 weeks | Experimental | Not described Receives: Drug: RO5024048; Drug: danoprevir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]; Drug: ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response (defined as unquantifiable serum HCV RNA) 12 weeks after treatment (SVR-12)
Measured: approximately 2 years
Secondary outcomes (7)
Sustained virologic response 4 weeks after treatment (SVR-4)
Measured: approximately 2 years
Sustained virologic response 24 weeks after treatment (SVR-24)
Measured: approximately 2 years
Change in serum HCV RNA levels
Measured: from baseline to Week 12
Virologic response over time
Measured: from baseline to 24 weeks after treatment
Correlation between trough concentrations of RO4995855 and virologic response
Measured: approximately 2 years
Incidence of direct-acting antiviral (DAA) resistance, including re-emergence of protease inhibitor resistant virus
Measured: approximately 2 years
Safety: Incidence of adverse events
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
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
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT01579019
- Sponsor's protocol ID
- NV22877
- Other IDs
- 2010-022659-41
- Status last verified
- Nov 2016
- First submitted
- 16 Apr 2012
- 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 Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C Genotype 1 Who Have Failed Prior HCV Protease Inhibitor Treatment
- ClinicalTrials.gov ID
- NCT01579019
- Acronym / sponsor ID
- NV22877
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 17 Apr 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.
This randomized, double blind, phase II study will evaluate the efficacy and safety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease inhibitor containing regimen with or without pegylated interferon. Patients will be randomized to receive either a 2-week lead-in of RO5024048 (1500 mg or 1000 mg orally twice daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or 1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with danoprevir (100 mg orally twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on study treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1000 mg 24 weeks | Active comparator | Drug: RO5024048, Drug: danoprevir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus] |
| 1000 mg 26 weeks | Active comparator | Drug: RO5024048, Drug: danoprevir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus], Drug: ritonavir |
| 1500 mg 24 weeks | Experimental | Drug: RO5024048, Drug: danoprevir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus], Drug: ritonavir |
| 1500 mg 26 weeks | Experimental | Drug: RO5024048, Drug: danoprevir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus], Drug: ritonavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients, >/= 18 years of age
- Hepatitis C genotype 1 infection
- Serum HCV quantifiable by Roche COBAS TaqMan HCV Test v2.0
- Liver biopsy (within 24 months) or Fibroscan (within 12 months) before first administration of study drug consistent with chronic hepatitis C and demonstrating absence of liver cirrhosis
- Documented failed prior treatment with protease inhibitor (evidenced by viral breakthrough or partial response while on treatment or relapse after treatment), including documentation on treatment with other direct-acting antiviral agents and other HCV antiviral treatment
Key exclusion criteria (15 listed)
- Infection with any HCV genotype other than genotype 1
- Evidence of any variants associated with protease inhibitor resistance at screening
- Body mass index (BMI) <18 or >/=36 kg/m2
- Positive for hepatitis A or hepatitis B infection
- Use of any systemic antiviral therapy with perceived activity against HCV </=1 month prior to first dose of study drug
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 |
|---|---|---|
| RO50240481500 mg po bid, 24 or 26 weeks | Drug | 1500 mg 24 weeks, 1500 mg 26 weeks |
| RO50240481000 mg po bid, 24 or 26 weeks | Drug | 1000 mg 24 weeks, 1000 mg 26 weeks |
| danoprevir100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26 | Drug | 1000 mg 24 weeks, 1000 mg 26 weeks, 1500 mg 24 weeks, 1500 mg 26 weeks |
| peginterferon alfa-2a [Pegasys]180 mcg sc qw, 24 or 26 weeks | Drug | 1000 mg 24 weeks, 1000 mg 26 weeks, 1500 mg 24 weeks, 1500 mg 26 weeks |
| ribavirin [Copegus]1000 mg or 1200 mg po daily, 24 or 26 weeks | Drug | 1000 mg 24 weeks, 1000 mg 26 weeks, 1500 mg 24 weeks, 1500 mg 26 weeks |
| ritonavir100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26 | Drug | 1000 mg 26 weeks, 1500 mg 24 weeks, 1500 mg 26 weeks |
Primary outcome
Sustained virologic response (defined as unquantifiable serum HCV RNA) 12 weeks after treatment (SVR-12)
Time frame: approximately 2 years
7 secondary outcomes
Sustained virologic response 4 weeks after treatment (SVR-4)
Time frame: approximately 2 years
Sustained virologic response 24 weeks after treatment (SVR-24)
Time frame: approximately 2 years
Change in serum HCV RNA levels
Time frame: from baseline to Week 12
Virologic response over time
Time frame: from baseline to 24 weeks after treatment
Correlation between trough concentrations of RO4995855 and virologic response
Time frame: approximately 2 years
Incidence of direct-acting antiviral (DAA) resistance, including re-emergence of protease inhibitor resistant virus
Time frame: approximately 2 years
Safety: Incidence of adverse events
Time frame: approximately 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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 RO5024048, danoprevir and peginterferon alfa-2a [Pegasys] 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 6 inclusion and 15 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.
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?
Sustained virologic response (defined as unquantifiable serum HCV RNA) 12 weeks after treatment (SVR-12) (time frame: approximately 2 years). 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; AzTrials last refreshed its copy on 7 Nov 2026.