Hepatitis C, ChronicPhase 2NCT01749150
A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis
A Phase 2 study testing danoprevir + ritonavir, peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 13 sites in 3 countries.
Trial summary
This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. 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?
- danoprevir + ritonavir, peginterferon alfa-2a [Pegasys] and ribavirin [Copegus]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Apr 2013to Feb 2015
- 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 of East Asian or Southeast Asian origin, >/= 18 years of age
- Presence of chronic genotype 1 hepatitis C infection
- Treatment-naïve
Who cannot join
- History or presence of decompensated liver disease
- Presence or history of non-hepatitis C chronic liver disease
- Positive for hepatitis B or HIV infection
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Taiwan6 sites
Study site
Chiayi County, 61363
Study site
Kaohsiung City, 807
Study site
Taichung, 40447
Study site
Taipei, 100
Study site
Taoyuan, 333
Study site
Yunlin County, 640
South Korea4 sites
Study site
Busan, 614-735
Study site
Seoul, 110-744
Study site
Seoul, 120-752
Study site
Seoul, 135-710
Thailand3 sites
Study site
Bangkok, 10330
Study site
Bangkok, 10700
Study site
Chiang Mai, 50200
About this study
Official title: STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RITONAVIR-BOOSTED DANOPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS OF ASIAN ORIGIN WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1 WITH OR WITHOUT COMPENSATED CIRRHOSIS
This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.
- Conditions
- Hepatitis C, Chronic
- Being tested
- danoprevir + ritonavir, peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
- 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.
danoprevir + ritonavirDrug
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
danoprevir + ritonavirDrug
125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc weekly, 12 weeks
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc weekly, 24 weeks
ribavirin [Copegus]Drug
1000-1200 mg orally daily in divided doses, 12 weeks
ribavirin [Copegus]Drug
1000-1200 mg orally daily in divided doses, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| with cirrhosis | Experimental | Not described Receives: Drug: danoprevir + ritonavir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus] |
| without cirrhosis | Experimental | Not described Receives: Drug: danoprevir + ritonavir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events
Measured: approximately 1.5 years
Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir
Measured: up to 14 days
Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System
Measured: from baseline to Week 36/48
Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study
Measured: approximately 1.5 years
Secondary outcomes (6)
Incidence of viral resistance to danoprevir
Measured: approximately 1.5 years
Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4
Measured: approximately 1.5 years
Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12
Measured: approximately 1.5 years
Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration
Measured: approximately 1.5 years
Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration
Measured: approximately 1.5 years
SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12
Measured: approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startApr 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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
- None (open label)
- Enrolment
- 61 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
- NCT01749150
- Sponsor's protocol ID
- YV28218
- Status last verified
- Nov 2016
- First submitted
- 11 Dec 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
- STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RITONAVIR-BOOSTED DANOPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS OF ASIAN ORIGIN WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1 WITH OR WITHOUT COMPENSATED CIRRHOSIS
- ClinicalTrials.gov ID
- NCT01749150
- Acronym / sponsor ID
- YV28218
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Dec 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 Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with cirrhosis | Experimental | Drug: danoprevir + ritonavir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus] |
| without cirrhosis | Experimental | Drug: danoprevir + ritonavir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients of East Asian or Southeast Asian origin, >/= 18 years of age
- Presence of chronic genotype 1 hepatitis C infection
- Treatment-naïve
Key exclusion criteria (3 listed)
- History or presence of decompensated liver disease
- Presence or history of non-hepatitis C chronic liver disease
- Positive for hepatitis B or HIV infection
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 |
|---|---|---|
| danoprevir + ritonavir125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks | Drug | without cirrhosis |
| danoprevir + ritonavir125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks | Drug | with cirrhosis |
| peginterferon alfa-2a [Pegasys]180 mcg sc weekly, 12 weeks | Drug | without cirrhosis |
| peginterferon alfa-2a [Pegasys]180 mcg sc weekly, 24 weeks | Drug | with cirrhosis |
| ribavirin [Copegus]1000-1200 mg orally daily in divided doses, 12 weeks | Drug | without cirrhosis |
| ribavirin [Copegus]1000-1200 mg orally daily in divided doses, 24 weeks | Drug | with cirrhosis |
Primary outcome
Safety: Incidence of adverse events
Time frame: approximately 1.5 years
Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir
Time frame: up to 14 days
Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System
Time frame: from baseline to Week 36/48
Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study
Time frame: approximately 1.5 years
6 secondary outcomes
Incidence of viral resistance to danoprevir
Time frame: approximately 1.5 years
Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4
Time frame: approximately 1.5 years
Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12
Time frame: approximately 1.5 years
Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration
Time frame: approximately 1.5 years
Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration
Time frame: approximately 1.5 years
SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12
Time frame: approximately 1.5 years
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
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing danoprevir + ritonavir, peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 13 sites in 3 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 3 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.
Where is the study taking place?
The record lists 13 sites in Taiwan, South Korea, Thailand. 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: approximately 1.5 years). The study lists 4 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 2 Nov 2016.