Hepatitis C, ChronicPhase 2NCT01057667
A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
A Phase 2 study testing RO5024048, Ribavirin [Copegus] and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 25 sites in 2 countries.
Trial summary
This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- RO5024048, Ribavirin [Copegus] 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
- 168 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Feb 2010to Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-70 years of age
- hepatitis C, genotype 1 or 4, of over 6 months duration
- treatment-naïve
- negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin
Who cannot join
- pregnant or breast feeding females or male partners of pregnant females
- previous interferon or ribavirin based therapy or investigational anti-HCV agent
- systemic antiviral therapy with established or perceived activity against HCV </=3 months prior to first dose of study drug
- hepatitis A or B, or HIV infection
- history or evidence of medical condition associated with chronic liver disease other than HCV
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States19 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Atlanta, Georgia, 30309
Study site
Bradenton, Florida, 34209
Study site
Chicago, Illinois, 60637
Study site
Columbia, South Carolina, 29204
Study site
Honolulu, Hawaii, 96813
Study site
Honolulu, Hawaii, 96817
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Kansas City, Kansas, 66160
Study site
Kansas City, Missouri, 64131
Study site
La Jolla, California, 92037-1030
Study site
Lebanon, New Hampshire, 03756
Study site
Nashville, Tennessee, 37232
Study site
New York, New York, 10003
Study site
New York, New York, 10021
Study site
Philadelphia, Pennsylvania, 19104
Study site
San Antonio, Texas, 78234
Study site
The Bronx, New York, 10468
Canada6 sites
Study site
Calgary, Alberta, T2N 4Z6
Study site
London, Ontario, N6A 5A5
Study site
Ottawa, Ontario, K1H 8L6
Study site
Vancouver, British Columbia, V5Z 1H2
Study site
Vancouver, British Columbia, V6Z 2K5
Study site
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4
This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.
- Conditions
- Hepatitis C, Chronic
- Being tested
- RO5024048, Ribavirin [Copegus], peginterferon alfa-2a [Pegasys]
- 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
1000mg bid po, 24 weeks
Ribavirin [Copegus]Drug
1000mg or 1200mg po daily
peginterferon alfa-2a [Pegasys]Drug
180mcg sc weekly
| Study group | Role | What they receive |
|---|---|---|
| Arm A: With RO5024048 | Experimental | Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Receives: Drug: RO5024048; Drug: Ribavirin [Copegus]; Drug: peginterferon alfa-2a [Pegasys] |
| Arm B: Standard treatment | Active comparator | Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Receives: Drug: Ribavirin [Copegus]; Drug: peginterferon alfa-2a [Pegasys] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test)
Measured: 24 weeks after last treatment dose
Secondary outcomes (3)
Virologic response over time
Measured: weeks 4, 12, 24, 36, 48 and 60
Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin
Measured: week 12 and 24
Resistance profile of RO5024048
Measured: weeks 1-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2012
- Study completionApr 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
- 168 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
- NCT01057667
- Sponsor's protocol ID
- NV22621
- Status last verified
- Nov 2016
- First submitted
- 26 Jan 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Najera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23.
PubMed 24154738
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, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4
- ClinicalTrials.gov ID
- NCT01057667
- Acronym / sponsor ID
- NV22621
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Jan 2010 (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 equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: With RO5024048 | Experimental | Drug: RO5024048, Drug: Ribavirin [Copegus], Drug: peginterferon alfa-2a [Pegasys]Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). |
| Arm B: Standard treatment | Active comparator | Drug: Ribavirin [Copegus], Drug: peginterferon alfa-2a [Pegasys]Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, 18-70 years of age
- hepatitis C, genotype 1 or 4, of over 6 months duration
- treatment-naïve
- negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin
Key exclusion criteria (5 listed)
- pregnant or breast feeding females or male partners of pregnant females
- previous interferon or ribavirin based therapy or investigational anti-HCV agent
- systemic antiviral therapy with established or perceived activity against HCV </=3 months prior to first dose of study drug
- hepatitis A or B, or HIV infection
- history or evidence of medical condition associated with chronic liver disease other than HCV
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 |
|---|---|---|
| RO50240481000mg bid po, 24 weeks | Drug | Arm A: With RO5024048 |
| Ribavirin [Copegus]1000mg or 1200mg po daily | Drug | Arm A: With RO5024048, Arm B: Standard treatment |
| peginterferon alfa-2a [Pegasys]180mcg sc weekly | Drug | Arm A: With RO5024048, Arm B: Standard treatment |
Primary outcome
Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test)
Time frame: 24 weeks after last treatment dose
3 secondary outcomes
Virologic response over time
Time frame: weeks 4, 12, 24, 36, 48 and 60
Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin
Time frame: week 12 and 24
Resistance profile of RO5024048
Time frame: weeks 1-24
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 24154738Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Najera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23.
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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
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO5024048, Ribavirin [Copegus] and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 25 sites in 2 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 4 inclusion and 5 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 25 sites in United States, Canada. 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?
Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test) (time frame: 24 weeks after last treatment dose). 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 NCT01057667, 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.