Hepatitis C, ChronicPhase 2NCT01482403
A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C
A Phase 2 study testing Copegus, Pegasys and boceprevir in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 24 sites in 7 countries.
Trial summary
This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. 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 boceprevir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 24 sitesin 7 countries
- Study dates
- Nov 2011to Jan 2014
- 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 infection for at least 6 months duration
- Hepatitis C genotype 1a or 1b
- Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
- Patient showed a previous null response to therapy as defined by < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV
Who cannot join
- Hepatitis C infection with a genotype other than genotype 1a or 1b
- Body mass index <18 or >/=36
- Hepatitis A, hepatitis B, or HIV infection
- Herbal remedies </=1 month prior to the first dose of study drug
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United States7 sites
Study site
Chesapeake, Virginia, 23320-1706
Study site
Chicago, Illinois, 60637
Study site
Detroit, Michigan, 48202
Study site
Kansas City, Missouri, 64128
Study site
Littleton, Colorado, 80120
Study site
San Antonio, Texas, 78215
Study site
Shreveport, Louisiana, 71130
Spain4 sites
Study site
Palma de Mallorca, Balearic Islands, 07010
Study site
Pontevedra, Pontevedra, 36071
Study site
Santander, Cantabria, 39008
Study site
Valencia, Valencia, 46014
Canada3 sites
Study site
Calgary, Alberta, T2N 4Z6
Study site
London, Ontario, N6A 5A5
Study site
Vancouver, British Columbia, V5Z 1H2
France3 sites
Study site
Créteil, 94010
Study site
Nice, 06202
Study site
Rennes, 35033
Germany3 sites
Study site
Berlin, 13353
Study site
Hamburg, 20099
Study site
Hanover, 30625
Italy3 sites
Study site
Florence, Tuscany, 50134
Study site
Milan, Lombardy, 20121
Study site
Naples, Campania, 80131
About this study
Official title: A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin
This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Copegus, Pegasys, boceprevir, mericitabine, mericitabine placebo
- 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
total daily dose of 1000 mg or 1200 mg for 24 weeks
CopegusDrug
total daily dose of 1000 mg or 1200 mg for 48 weeks
PegasysDrug
180 microgram subcutaneous once a week for 24 weeks
PegasysDrug
180 microgram subcutaneous once a week for 48 weeks
boceprevirDrug
800 mg three times a day for 24 weeks
boceprevirDrug
800 mg three times a day for 48 weeks
mericitabineDrug
1000 mg twice daily for 24 weeks
mericitabine placeboDrug
mericitabine placebo
boceprevir placeboDrug
boceprevir placebo
boceprevirDrug
800 mg three times a day for 44 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | 24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period. Receives: Drug: Copegus; Drug: Pegasys; Drug: boceprevir; Drug: mericitabine |
| Treatment Arm B | Experimental | 24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period. Receives: Drug: Copegus; Drug: Pegasys; Drug: boceprevir; Drug: mericitabine |
| Treatment Arm C (Control) | Active comparator | 4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period. Receives: Drug: Copegus; Drug: Pegasys; Drug: mericitabine placebo; Drug: boceprevir placebo; Drug: boceprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response 12 weeks after treatment (SVR-12)
Measured: up to 60 weeks
Secondary outcomes (7)
Sustained virological response 4 weeks after treatment
Measured: up to 52 weeks
Virologic response over time
Measured: 60 weeks
Proportion of patients who develop treatment resistance
Measured: 60 weeks
Safety (incidence of adverse events)
Measured: 60 weeks
Pharmacokinetics: trough concentration of RO4995855
Measured: Day 1 and Week 8
Pharmacokinetics: trough concentration of RO5012433
Measured: Day 1 and Week 8
Pharmacokinetics: trough concentration of boceprevir
Measured: Day 1 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2014
- Study completionJan 2014
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
- 58 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
- NCT01482403
- Sponsor's protocol ID
- NV27780
- Other IDs
- 2011-002714-37
- Status last verified
- Aug 2016
- First submitted
- 28 Nov 2011
- Last updated
- 5 Aug 2016
- Results posted
- No
Publications
Wedemeyer H, Forns X, Hezode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Najera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016.
PubMed 26752189
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin
- ClinicalTrials.gov ID
- NCT01482403
- Acronym / sponsor ID
- NV27780
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Nov 2011 (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 randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: Copegus, Drug: Pegasys, Drug: boceprevir, Drug: mericitabine24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period. |
| Treatment Arm B | Experimental | Drug: Copegus, Drug: Pegasys, Drug: boceprevir, Drug: mericitabine24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period. |
| Treatment Arm C (Control) | Active comparator | Drug: Copegus, Drug: Pegasys, Drug: mericitabine placebo, Drug: boceprevir placebo, Drug: boceprevir4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients, >/=18 years of age
- Chronic hepatitis C infection for at least 6 months duration
- Hepatitis C genotype 1a or 1b
- Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
- Patient showed a previous null response to therapy as defined by < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV
Key exclusion criteria (4 listed)
- Hepatitis C infection with a genotype other than genotype 1a or 1b
- Body mass index <18 or >/=36
- Hepatitis A, hepatitis B, or HIV infection
- Herbal remedies </=1 month prior to the first dose of study drug
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 |
|---|---|---|
| Copegustotal daily dose of 1000 mg or 1200 mg for 24 weeks | Drug | Treatment Arm A |
| Copegustotal daily dose of 1000 mg or 1200 mg for 48 weeks | Drug | Treatment Arm B, Treatment Arm C (Control) |
| Pegasys180 microgram subcutaneous once a week for 24 weeks | Drug | Treatment Arm A |
| Pegasys180 microgram subcutaneous once a week for 48 weeks | Drug | Treatment Arm B, Treatment Arm C (Control) |
| boceprevir800 mg three times a day for 24 weeks | Drug | Treatment Arm A |
| boceprevir800 mg three times a day for 48 weeks | Drug | Treatment Arm B |
| mericitabine1000 mg twice daily for 24 weeks | Drug | Treatment Arm A, Treatment Arm B |
| mericitabine placebomericitabine placebo | Drug | Treatment Arm C (Control) |
| boceprevir placeboboceprevir placebo | Drug | Treatment Arm C (Control) |
| boceprevir800 mg three times a day for 44 weeks | Drug | Treatment Arm C (Control) |
Primary outcome
Sustained virological response 12 weeks after treatment (SVR-12)
Time frame: up to 60 weeks
7 secondary outcomes
Sustained virological response 4 weeks after treatment
Time frame: up to 52 weeks
Virologic response over time
Time frame: 60 weeks
Proportion of patients who develop treatment resistance
Time frame: 60 weeks
Safety (incidence of adverse events)
Time frame: 60 weeks
Pharmacokinetics: trough concentration of RO4995855
Time frame: Day 1 and Week 8
Pharmacokinetics: trough concentration of RO5012433
Time frame: Day 1 and Week 8
Pharmacokinetics: trough concentration of boceprevir
Time frame: Day 1 and Week 8
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 5 Aug 2016.
- Derived from this study: PubMed 26752189Wedemeyer H, Forns X, Hezode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Najera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 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
24 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 boceprevir in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 24 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 5 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Spain, Canada, France, 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. 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 12 weeks after treatment (SVR-12) (time frame: up to 60 weeks). 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 NCT01482403, 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 5 Aug 2016.