Hepatitis C, ChronicPhase 2NCT00963885
A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection
A Phase 2 study testing Copegus, Pegasys and RO5190591 (Danoprevir) in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 43 sites in 7 countries.
Trial summary
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be… 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?
- Copegus, Pegasys and RO5190591 (Danoprevir)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 229 participants
- Where
- 43 sitesin 7 countries
- Study dates
- Aug 2009to Jan 2012
- 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;
- chronic hepatitis C, genotype 1;
- treatment-naive.
Who cannot join
- liver cirrhosis and other forms of liver disease;
- HIV infection;
- hepatocellular cancer;
- cardiac disease.
Trial locations and contacts
43 sites in 7 countries.
43 sites in 7 countries
United States24 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Asheville, North Carolina, 28801
Study site
Aurora, Colorado, 80045
Study site
Chapel Hill, North Carolina, 27599-7584
Study site
Detroit, Michigan, 48202-2689
Study site
Gainesville, Florida, 32610-0214
Study site
Jacksonville, Florida, 32256
Study site
Lancaster, Pennsylvania, 17604-3200
Study site
Lombard, Illinois, 60148
Study site
Long Beach, California, 90822
Study site
Los Angeles, California, 90045
Study site
Manhasset, New York, 11030
Study site
Medford, Oregon, 97504
Study site
Milwaukee, Wisconsin, 53210
Study site
New Orleans, Louisiana, 70112
Study site
New York, New York, 10029-6574
Study site
Orlando, Florida, 32809
Study site
Phoenix, Arizona, 85054
Study site
Sacramento, California, 95817
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78215
Study site
San Diego, California, 92123
Study site
San Diego, California, 92154
Study site
Vancouver, Washington, 98664
Canada8 sites
Study site
Calgary, Alberta, T2N 4Z6
Study site
Edmonton, Alberta, T5H 4B9
Study site
Edmonton, Alberta, T6G 2B7
Study site
Ottawa, Ontario, K1H 8L6
Study site
Toronto, Ontario, M5G 1L7
Study site
Vancouver, British Columbia, V5Z 1H2
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Winnipeg, Manitoba, R3A 1R9
France4 sites
Study site
Clichy, 92118
Study site
Marseille, 13285
Study site
Montpellier, 34295
Study site
Paris, 75651
Australia3 sites
Study site
Adelaide, South Australia, 5000
Study site
Heidelberg, Victoria, 3084
Study site
Kingswood, New South Wales
About this study
Official title: A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Copegus, Pegasys, Placebo, RO5190591 (Danoprevir)
- 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.
CopegusDrug
1000 or 1200mg po daily for 24 or 48 weeks
PegasysDrug
180micrograms sc weekly for 24 or 48 weeks
PlaceboDrug
po for 12 weeks
PlaceboDrug
po for 24 weeks
RO5190591 (Danoprevir)Drug
300mg po q8h for 12 weeks
RO5190591 (Danoprevir)Drug
600mg po q12h for 12 weeks
RO5190591 (Danoprevir)Drug
900mg po q12h for 12 weeks
RO5190591 (Danoprevir)Drug
300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Placebo | Placebo comparator | Placebo in combination with standard doses of Pegasys and Copegus. Receives: Drug: Copegus; Drug: Pegasys; Drug: Placebo |
| Part 1: RO5190591 300mg po | Experimental | RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus. Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5190591 (Danoprevir) |
| Part 1: RO5190591 600mg po | Experimental | RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus. Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5190591 (Danoprevir) |
| Part 1: RO5190591 900mg po | Experimental | RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus. Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5190591 (Danoprevir) |
| Part 2: Placebo | Placebo comparator | If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus. Receives: Drug: Copegus; Drug: Pegasys; Drug: Placebo |
| Part 2: RO5190591 300mg po | Experimental | If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus. Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5190591 (Danoprevir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response
Measured: 24 weeks after end of treatment
Secondary outcomes (2)
Virological response over time
Measured: At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment
Adverse events; laboratory parameters
Measured: Throughout study, laboratory parameters every 2 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 229 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
- NCT00963885
- Sponsor's protocol ID
- NV21075
- Other IDs
- 2009-009608-38, 2009
- Status last verified
- Nov 2016
- First submitted
- 18 Aug 2009
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Marcellin P, Cooper C, Balart L, Larrey D, Box T, Yoshida E, Lawitz E, Buggisch P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Najera I, Thomas D, Hooper G, Shulman NS, Zhang Y, Navarro MT, Lim CY, Brunda M, Terrault NA, Yetzer ES. Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Gastroenterology. 2013 Oct;145(4):790-800.e3. doi: 10.1053/j.gastro.2013.06.051. Epub 2013 Jun 26.
PubMed 23811112
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 Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
- ClinicalTrials.gov ID
- NCT00963885
- Acronym / sponsor ID
- NV21075
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Aug 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.
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Placebo | Placebo comparator | Drug: Copegus, Drug: Pegasys, Drug: PlaceboPlacebo in combination with standard doses of Pegasys and Copegus. |
| Part 1: RO5190591 300mg po | Experimental | Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir)RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus. |
| Part 1: RO5190591 600mg po | Experimental | Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir)RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus. |
| Part 1: RO5190591 900mg po | Experimental | Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir)RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus. |
| Part 2: Placebo | Placebo comparator | Drug: Copegus, Drug: Pegasys, Drug: PlaceboIf the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus. |
| Part 2: RO5190591 300mg po | Experimental | Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir)If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and 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, >=18 years of age;
- chronic hepatitis C, genotype 1;
- treatment-naive.
Key exclusion criteria (4 listed)
- liver cirrhosis and other forms of liver disease;
- HIV infection;
- hepatocellular cancer;
- cardiac 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 |
|---|---|---|
| Copegus1000 or 1200mg po daily for 24 or 48 weeks | Drug | Part 1: Placebo, Part 1: RO5190591 300mg po, Part 1: RO5190591 600mg po, Part 1: RO5190591 900mg po, Part 2: Placebo, Part 2: RO5190591 300mg po |
| Pegasys180micrograms sc weekly for 24 or 48 weeks | Drug | Part 1: Placebo, Part 1: RO5190591 300mg po, Part 1: RO5190591 600mg po, Part 1: RO5190591 900mg po, Part 2: Placebo, Part 2: RO5190591 300mg po |
| Placebopo for 12 weeks | Drug | Part 1: Placebo |
| Placebopo for 24 weeks | Drug | Part 2: Placebo |
| RO5190591 (Danoprevir)300mg po q8h for 12 weeks | Drug | Part 1: RO5190591 300mg po |
| RO5190591 (Danoprevir)600mg po q12h for 12 weeks | Drug | Part 1: RO5190591 600mg po |
| RO5190591 (Danoprevir)900mg po q12h for 12 weeks | Drug | Part 1: RO5190591 900mg po |
| RO5190591 (Danoprevir)300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks | Drug | Part 2: RO5190591 300mg po |
Primary outcome
Sustained virological response
Time frame: 24 weeks after end of treatment
2 secondary outcomes
Virological response over time
Time frame: At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment
Adverse events; laboratory parameters
Time frame: Throughout study, laboratory parameters every 2 to 6 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.
- Derived from this study: PubMed 23811112Marcellin P, Cooper C, Balart L, Larrey D, Box T, Yoshida E, Lawitz E, Buggisch P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Najera I, Thomas D, Hooper G, Shulman NS, Zhang Y, Navarro MT, Lim CY, Brunda M, Terrault NA, Yetzer ES. Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Gastroenterology. 2013 Oct;145(4):790-800.e3. doi: 10.1053/j.gastro.2013.06.051. Epub 2013 Jun 26.
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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
43 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 Copegus, Pegasys and RO5190591 (Danoprevir) in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 43 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 3 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 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 43 sites in United States, Canada, France, Australia, Germany 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. 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?
Sustained virological response (time frame: 24 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00963885, which also lists 1 linked publication.
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.