Hepatitis C, ChronicPhase 2NCT01483742
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
A Phase 2 study testing RO5024048, danoprevir and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 27 sites in 7 countries.
Trial summary
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients… 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?
- RO5024048, danoprevir and peginterferon alfa-2a [Pegasys]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 27 sitesin 7 countries
- Study dates
- Apr 2012to Sep 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
- Chronic hepatitis C, genotype 1 or 4
- Cohort 1: Treatment-naïve for hepatitis C
- Cohort 2: Prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
- Liver biopsy confirming cirrhosis
- Compensated cirrhosis (Child-Pugh A)
Who cannot join
- Pregnant or lactating women or male partners of women who are pregnant
- History or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
- Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
- History of clinically significant cardiovascular or cerebrovascular disease
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
United States15 sites
Study site
Anaheim, California, 92801
Study site
Atlanta, Georgia, 30308
Study site
Atlanta, Georgia, 30309
Study site
Birmingham, Alabama, 35294
Study site
Coronado, California, 92118
Study site
DeLand, Florida, 32720
Study site
Detroit, Michigan, 48202-2689
Study site
Hillsborough, New Jersey, 08844
Study site
La Jolla, California, 92037
Study site
Long Beach, California, 90807
Study site
Miami, Florida, 33136
Study site
New Orleans, Louisiana, 70112
Study site
New York, New York, 10021
Study site
Orlando, Florida, 32803
Study site
San Antonio, Texas, 78215
Poland4 sites
Study site
Chorzów, 41-500
Study site
Mysłowice, 41-400
Study site
Warsaw, 02-507
Study site
Wroclaw, 51-149
Australia2 sites
Study site
Fitzroy, South Australia, 3065
Study site
Melbourne, Victoria, 3124
Canada2 sites
Study site
Toronto, Ontario, M5G 2C4
Study site
Vancouver, British Columbia, V6Z 2C7
About this study
Official title: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.
- Conditions
- Hepatitis C, Chronic
- 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
1000 mg orally bid, 24 weeks
danoprevirDrug
100 mg orally bid, 24 weeks
peginterferon alfa-2a [Pegasys]Drug
180 mcg weekly, 24 weeks
ribavirinDrug
1000-1200 mg/kg/day orally in two divided doses, 24 weeks
ritonavirDrug
100 mg orally bid, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Combination without RO5024048 | Experimental | Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients Receives: Drug: danoprevir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin; Drug: ritonavir |
| Combination with RO5024048 | Experimental | RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys [peginterferon alfa-2a] and ribavirin) in prior null responder patients Receives: Drug: RO5024048; Drug: danoprevir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin; Drug: ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: 48 weeks
Pharmacokinetics (PK): Area under the concentration-time curve (AUC)
Measured: Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24
Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test
Measured: 48 weeks
Secondary outcomes (2)
Emergence of viral resistance: HCV RNA gene sequence variations
Measured: From baseline to Week 48
Virologic response: HCV RNA levels
Measured: approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startApr 2012
- Primary completionSep 2013
- Study completionSep 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT01483742
- Sponsor's protocol ID
- NP27946
- Other IDs
- 2011-004129-28
- Status last verified
- Jul 2016
- First submitted
- 30 Nov 2011
- Last updated
- 1 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
- ClinicalTrials.gov ID
- NCT01483742
- Acronym / sponsor ID
- NP27946
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Dec 2011 (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 open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination without RO5024048 | Experimental | Drug: danoprevir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin, Drug: ritonavirRitonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients |
| Combination with RO5024048 | Experimental | Drug: RO5024048, Drug: danoprevir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin, Drug: ritonavirRO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys [peginterferon alfa-2a] and ribavirin) in prior null responder patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients, 18 to 65 years of age inclusive
- Chronic hepatitis C, genotype 1 or 4
- Cohort 1: Treatment-naïve for hepatitis C
- Cohort 2: Prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
- Liver biopsy confirming cirrhosis
Key exclusion criteria (4 listed)
- Pregnant or lactating women or male partners of women who are pregnant
- History or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
- Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
- History of clinically significant cardiovascular or cerebrovascular 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 |
|---|---|---|
| RO50240481000 mg orally bid, 24 weeks | Drug | Combination with RO5024048 |
| danoprevir100 mg orally bid, 24 weeks | Drug | Combination with RO5024048, Combination without RO5024048 |
| peginterferon alfa-2a [Pegasys]180 mcg weekly, 24 weeks | Drug | Combination with RO5024048, Combination without RO5024048 |
| ribavirin1000-1200 mg/kg/day orally in two divided doses, 24 weeks | Drug | Combination with RO5024048, Combination without RO5024048 |
| ritonavir100 mg orally bid, 24 weeks | Drug | Combination with RO5024048, Combination without RO5024048 |
Primary outcome
Safety: Incidence of adverse events
Time frame: 48 weeks
Pharmacokinetics (PK): Area under the concentration-time curve (AUC)
Time frame: Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24
Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test
Time frame: 48 weeks
2 secondary outcomes
Emergence of viral resistance: HCV RNA gene sequence variations
Time frame: From baseline to Week 48
Virologic response: HCV RNA levels
Time frame: approximately 1 year
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 1 Aug 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
27 sites in 7 countries: see every site and its status.
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 at 27 sites in 7 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 6 inclusion and 4 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 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Poland, Australia, Canada, New Zealand and 2 more countries. 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 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?
Safety: Incidence of adverse events (time frame: 48 weeks). The study lists 3 primary outcomes in all. 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 1 Aug 2016.