Hepatitis C, ChronicPhase 3NCT01296971
A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)
A Phase 3 study testing peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche.
Trial summary
This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. 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?
- peginterferon alfa-2a [Pegasys] and ribavirin [Copegus]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Dec 2009
- Phase
- Phase 3
- 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
- Measurable serum HVC RNA levels
- Compensated liver disease (Child-Pugh class A)
- Treatment-naive for standard or pegylated interferons, or non-responder or relapsing
Who cannot join
- Concomitant hepatitis A or B
- History of chronic liver disease not caused by hepatitis C virus
- Hepatocellular carcinoma
- History or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease
- Treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug
- Pregnant or lactating women, or men whose partners are pregnant
About this study
Official title: Open-label, Multicenter, Non-Comparative Prospective Study to Assess the Safety of Individualized Combination Therapy With Ribavirin And Peginterferon Alfa-2a (40 kD) in Patients With Chronic Hepatitis C (CHC) (MASTER Study)
This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.
- Conditions
- Hepatitis C, Chronic
- Being tested
- peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
- 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.
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc weekly
ribavirin [Copegus]Drug
1'000/1'200 mg daily orally, 24 - 72 weeks
ribavirin [Copegus]Drug
800 mg daily orally, 16 - 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | genotype 1, treatment-naive Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus] |
| B | Experimental | genotype 2 and 3, treatment-naive Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus] |
| C | Experimental | all genotypes, non-responders or relapses Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of individualized Copegus treatment in combination with Pegasys: Adverse events
Measured: up to 96 weeks
Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)
Measured: up to 96 weeks
Secondary outcomes (1)
Virological response/sustained virological response (serum HCV RNA levels)
Measured: 24 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startDec 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: study was not started due to an administrative reason on the part of the local Health Authority
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT01296971
- Sponsor's protocol ID
- ML25246
- Status last verified
- Nov 2016
- First submitted
- 21 Dec 2010
- 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
- Open-label, Multicenter, Non-Comparative Prospective Study to Assess the Safety of Individualized Combination Therapy With Ribavirin And Peginterferon Alfa-2a (40 kD) in Patients With Chronic Hepatitis C (CHC) (MASTER Study)
- ClinicalTrials.gov ID
- NCT01296971
- Acronym / sponsor ID
- ML25246
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study was not started due to an administrative reason on the part of the local Health Authority
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 Feb 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 open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus]genotype 1, treatment-naive |
| B | Experimental | Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus]genotype 2 and 3, treatment-naive |
| C | Experimental | Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus]all genotypes, non-responders or relapses |
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
- Measurable serum HVC RNA levels
- Compensated liver disease (Child-Pugh class A)
- Treatment-naive for standard or pegylated interferons, or non-responder or relapsing
Key exclusion criteria (6 listed)
- Concomitant hepatitis A or B
- History of chronic liver disease not caused by hepatitis C virus
- Hepatocellular carcinoma
- History or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease
- Treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to 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 |
|---|---|---|
| peginterferon alfa-2a [Pegasys]180 mcg sc weekly | Drug | A, B, C |
| ribavirin [Copegus]1'000/1'200 mg daily orally, 24 - 72 weeks | Drug | A, C |
| ribavirin [Copegus]800 mg daily orally, 16 - 48 weeks | Drug | B |
Primary outcome
Safety of individualized Copegus treatment in combination with Pegasys: Adverse events
Time frame: up to 96 weeks
Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)
Time frame: up to 96 weeks
1 secondary outcome
Virological response/sustained virological response (serum HCV RNA levels)
Time frame: 24 weeks after treatment completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing peginterferon alfa-2a [Pegasys] and ribavirin [Copegus] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche.
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 6 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: withdrawn, 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.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 of individualized Copegus treatment in combination with Pegasys: Adverse events (time frame: up to 96 weeks). The study lists 2 primary outcomes in all. 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.