Hepatitis C, ChronicPhase 1NCT01185860
A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1
A Phase 1 study testing danoprevir, peginterferon alfa-2a [Pegasys] and ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 4 sites in 3 countries.
Trial summary
This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. 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?
- danoprevir, peginterferon alfa-2a [Pegasys] and ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Aug 2009to Jan 2012
- Phase
- Phase 1
- 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
- Adults, 18-65 years of age
- Chronic hepatitis C genotype 1
- HCV treatment naïve, or without sustained virologic response on prior PEG-INF/RBV treatment
- Body mass index (BMI) 18 - 35 kg/m2, inclusive; minimum weight 45 kg
Who cannot join
- Liver cirrhosis
- Decompensated liver disease or impaired liver function
- Medical condition associated with chronic liver disease other than chronic hepatitis C
- Positive for hepatitis B or HIV infection at screening
- History of alcohol consumption exceeding 2 standard drinks per day when averaged over the course of a given week
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
Official title: A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1
This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 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.
danoprevirDrug
oral doses
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc once weekly
placeboDrug
oral doses
ribavirinDrug
1000-1200mg/day po
ritonavirDrug
oral doses
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: danoprevir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin |
| B | Experimental | Not described Receives: Drug: danoprevir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin; Drug: ritonavir |
| C | Placebo comparator | Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: placebo; Drug: ribavirin; Drug: ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Adverse events, ECG, laboratory parameters
Measured: approximately 3 years
Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2
Measured: Days 3-9
Antiviral activity: HCV RNA (COBAS Taqman HCV Test)
Measured: from baseline to Day 28
Secondary outcomes (4)
Viral resistance development
Measured: from baseline to Day 17
Effects on cytochrome P450(CYP)2C9 and 3A isozymes
Measured: from baseline to Day 17
Virological response in prior null-responders
Measured: from baseline to week 72
Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment
Measured: approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (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 (3)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 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
- NCT01185860
- Sponsor's protocol ID
- NP22660
- Other IDs
- 2009-012426-36, 2009
- Status last verified
- Nov 2016
- First submitted
- 19 Aug 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Gane EJ, Rouzier R, Wiercinska-Drapalo A, Larrey DG, Morcos PN, Brennan BJ, Le Pogam S, Najera I, Petric R, Tran JQ, Kulkarni R, Zhang Y, Smith P, Yetzer ES, Shulman NS. Efficacy and safety of danoprevir-ritonavir plus peginterferon alfa-2a-ribavirin in hepatitis C virus genotype 1 prior null responders. Antimicrob Agents Chemother. 2014;58(2):1136-45. doi: 10.1128/AAC.01515-13. Epub 2013 Dec 2.
PubMed 24295986Morcos PN, Chang L, Kulkarni R, Giraudon M, Shulman N, Brennan BJ, Smith PF, Tran JQ. A randomised study of the effect of danoprevir/ritonavir or ritonavir on substrates of cytochrome P450 (CYP) 3A and 2C9 in chronic hepatitis C patients using a drug cocktail. Eur J Clin Pharmacol. 2013 Nov;69(11):1939-49. doi: 10.1007/s00228-013-1556-y. Epub 2013 Jul 20.
PubMed 23872824Gane EJ, Rouzier R, Stedman C, Wiercinska-Drapalo A, Horban A, Chang L, Zhang Y, Sampeur P, Najera I, Smith P, Shulman NS, Tran JQ. Antiviral activity, safety, and pharmacokinetics of danoprevir/ritonavir plus PEG-IFN alpha-2a/RBV in hepatitis C patients. J Hepatol. 2011 Nov;55(5):972-9. doi: 10.1016/j.jhep.2011.01.046. Epub 2011 Feb 24.
PubMed 21354234
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 Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1
- ClinicalTrials.gov ID
- NCT01185860
- Acronym / sponsor ID
- NP22660
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 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
- 20 Aug 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 study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: danoprevir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin |
| B | Experimental | Drug: danoprevir, Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin, Drug: ritonavir |
| C | Placebo comparator | Drug: peginterferon alfa-2a [Pegasys], Drug: placebo, Drug: ribavirin, Drug: ritonavir |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults, 18-65 years of age
- Chronic hepatitis C genotype 1
- HCV treatment naïve, or without sustained virologic response on prior PEG-INF/RBV treatment
- Body mass index (BMI) 18 - 35 kg/m2, inclusive; minimum weight 45 kg
Key exclusion criteria (5 listed)
- Liver cirrhosis
- Decompensated liver disease or impaired liver function
- Medical condition associated with chronic liver disease other than chronic hepatitis C
- Positive for hepatitis B or HIV infection at screening
- History of alcohol consumption exceeding 2 standard drinks per day when averaged over the course of a given week
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 |
|---|---|---|
| danopreviroral doses | Drug | A, B |
| peginterferon alfa-2a [Pegasys]180 mcg sc once weekly | Drug | A, B, C |
| placebooral doses | Drug | C |
| ribavirin1000-1200mg/day po | Drug | A, B, C |
| ritonaviroral doses | Drug | B, C |
Primary outcome
Safety and tolerability: Adverse events, ECG, laboratory parameters
Time frame: approximately 3 years
Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2
Time frame: Days 3-9
Antiviral activity: HCV RNA (COBAS Taqman HCV Test)
Time frame: from baseline to Day 28
4 secondary outcomes
Viral resistance development
Time frame: from baseline to Day 17
Effects on cytochrome P450(CYP)2C9 and 3A isozymes
Time frame: from baseline to Day 17
Virological response in prior null-responders
Time frame: from baseline to week 72
Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment
Time frame: approximately 3 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.
- Derived from this study: PubMed 24295986Gane EJ, Rouzier R, Wiercinska-Drapalo A, Larrey DG, Morcos PN, Brennan BJ, Le Pogam S, Najera I, Petric R, Tran JQ, Kulkarni R, Zhang Y, Smith P, Yetzer ES, Shulman NS. Efficacy and safety of danoprevir-ritonavir plus peginterferon alfa-2a-ribavirin in hepatitis C virus genotype 1 prior null responders. Antimicrob Agents Chemother. 2014;58(2):1136-45. doi: 10.1128/AAC.01515-13. Epub 2013 Dec 2.
- Derived from this study: PubMed 23872824Morcos PN, Chang L, Kulkarni R, Giraudon M, Shulman N, Brennan BJ, Smith PF, Tran JQ. A randomised study of the effect of danoprevir/ritonavir or ritonavir on substrates of cytochrome P450 (CYP) 3A and 2C9 in chronic hepatitis C patients using a drug cocktail. Eur J Clin Pharmacol. 2013 Nov;69(11):1939-49. doi: 10.1007/s00228-013-1556-y. Epub 2013 Jul 20.
- Derived from this study: PubMed 21354234Gane EJ, Rouzier R, Stedman C, Wiercinska-Drapalo A, Horban A, Chang L, Zhang Y, Sampeur P, Najera I, Smith P, Shulman NS, Tran JQ. Antiviral activity, safety, and pharmacokinetics of danoprevir/ritonavir plus PEG-IFN alpha-2a/RBV in hepatitis C patients. J Hepatol. 2011 Nov;55(5):972-9. doi: 10.1016/j.jhep.2011.01.046. Epub 2011 Feb 24.
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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
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing danoprevir, peginterferon alfa-2a [Pegasys] and ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 4 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 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 4 sites in New Zealand, France, Poland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 and tolerability: Adverse events, ECG, laboratory parameters (time frame: approximately 3 years). 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?
On the ClinicalTrials.gov record for NCT01185860, which also lists 3 linked publications.
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.