Hepatitis C, ChronicPhase 2NCT00377182
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
A Phase 2 study testing Copegus, PEGASYS and RO5024048 1500mg in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 18 sites in 2 countries.
Trial summary
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. 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?
- Copegus, PEGASYS and RO5024048 1500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Sep 2006to Aug 2008
- 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, 18-65 years of age;
- CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
- chronic liver disease consistent with CHC.
Who cannot join
- infection with any HCV genotype other than genotype 1;
- previous treatment for CHC;
- medical condition associated with chronic liver disease other than CHC;
- HIV, Hepatitis A, Hepatitis B infection.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Study site
Aurora, Colorado, 80045
Study site
Bradenton, Florida, 34209
Study site
Chapel Hill, North Carolina, 27599-7584
Study site
Chicago, Illinois, 60637
Study site
Dallas, Texas, 75203
Study site
Fort Sam Houston, Texas, 78234-3879
Study site
Gainesville, Florida, 32610-0214
Study site
La Jolla, California, 92037-1030
Study site
Long Beach, California, 90822
Study site
Manhasset, New York, 11030
Study site
New York, New York, 10029
Study site
Novi, Michigan, 48377
Study site
Richmond, Virginia, 23249
Study site
Sacramento, California, 95817
Study site
San Diego, California, 92103-8465
Study site
San Diego, California, 92154
Study site
San Francisco, California, 94115
About this study
Official title: A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Copegus, PEGASYS, RO5024048 1500mg, RO5024048 3000mg
- 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
1000/1200mg po daily for 4 weeks
PEGASYSDrug
180 micrograms sc weekly for 4 weeks
RO5024048 1500mgDrug
1500mg po bid for 4 weeks
RO5024048 3000mgDrug
3000mg po bid for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEGASYS with COPEGUS | Active comparator | Not described Receives: Drug: Copegus; Drug: PEGASYS |
| RO5024048 1500mg in combination with PEGASYS | Experimental | Not described Receives: Drug: PEGASYS; Drug: RO5024048 1500mg |
| RO5024048 3000mg in combination with PEGASYS | Experimental | Not described Receives: Drug: PEGASYS; Drug: RO5024048 3000mg |
| RO5024048 in combination with PEGASYS and COPEGUS | Experimental | Not described Receives: Drug: Copegus; Drug: PEGASYS; Drug: RO5024048 1500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs) and laboratory parameters.
Measured: Week 4, 8 and Week 72
Secondary outcomes (2)
Plasma concentration of HCV polymerase inhibitor
Measured: Week 4 and 8
Antiviral activity
Measured: Week 4, 8 and Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2008
- Study completionAug 2008
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 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
- NCT00377182
- Sponsor's protocol ID
- PV18369
- Status last verified
- Nov 2016
- First submitted
- 15 Sep 2006
- 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 Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1
- ClinicalTrials.gov ID
- NCT00377182
- Acronym / sponsor ID
- PV18369
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Sep 2006 (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 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEGASYS with COPEGUS | Active comparator | Drug: Copegus, Drug: PEGASYS |
| RO5024048 1500mg in combination with PEGASYS | Experimental | Drug: PEGASYS, Drug: RO5024048 1500mg |
| RO5024048 3000mg in combination with PEGASYS | Experimental | Drug: PEGASYS, Drug: RO5024048 3000mg |
| RO5024048 in combination with PEGASYS and COPEGUS | Experimental | Drug: Copegus, Drug: PEGASYS, Drug: RO5024048 1500mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients, 18-65 years of age;
- CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
- chronic liver disease consistent with CHC.
Key exclusion criteria (4 listed)
- infection with any HCV genotype other than genotype 1;
- previous treatment for CHC;
- medical condition associated with chronic liver disease other than CHC;
- HIV, Hepatitis A, Hepatitis B 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 |
|---|---|---|
| Copegus1000/1200mg po daily for 4 weeks | Drug | PEGASYS with COPEGUS, RO5024048 in combination with PEGASYS and COPEGUS |
| PEGASYS180 micrograms sc weekly for 4 weeks | Drug | PEGASYS with COPEGUS, RO5024048 1500mg in combination with PEGASYS, RO5024048 3000mg in combination with PEGASYS, RO5024048 in combination with PEGASYS and COPEGUS |
| RO5024048 1500mg1500mg po bid for 4 weeks | Drug | RO5024048 1500mg in combination with PEGASYS, RO5024048 in combination with PEGASYS and COPEGUS |
| RO5024048 3000mg3000mg po bid for 4 weeks | Drug | RO5024048 3000mg in combination with PEGASYS |
Primary outcome
Adverse events (AEs) and laboratory parameters.
Time frame: Week 4, 8 and Week 72
2 secondary outcomes
Plasma concentration of HCV polymerase inhibitor
Time frame: Week 4 and 8
Antiviral activity
Time frame: Week 4, 8 and Week 72
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
18 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 Copegus, PEGASYS and RO5024048 1500mg in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 18 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 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 18 sites in United States, Puerto Rico. 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?
Adverse events (AEs) and laboratory parameters. (time frame: Week 4, 8 and Week 72). 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.