Hepatitis B, ChronicPhase 4NCT01179594
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
A Phase 4 study testing entecavir and peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche.
Trial summary
This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- entecavir and peginterferon alfa-2a [Pegasys]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2010to Nov 2014
- Phase
- Phase 4
- 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 B for >/= 6 months
- HBeAg negative at screening
- adequate renal function
Who cannot join
- antiviral therapy for chronic hepatitis B within the previous 6 months
- hepatitis A, C, D or HIV infection
- treatment with systemic acyclovir or famciclovir within the previous 6 months
- decompensated liver disease (Childs B-C)
- history or evidence of a medical condition associated with chronic liver disease
About this study
Official title: A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.
This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is <500 patients.
- Conditions
- Hepatitis B, Chronic
- Being tested
- entecavir, peginterferon alfa-2a [Pegasys], placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entecavirDrug
0.5 mg orally daily, 24 weeks (weeks 12-36)
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc weekly, 48 weeks
peginterferon alfa-2a [Pegasys]Drug
180 mcg sc weekly, 96 weeks
placeboDrug
orally daily, 24 weeks (weeks 12-36)
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: placebo |
| B | Experimental | Not described Receives: Drug: entecavir; Drug: peginterferon alfa-2a [Pegasys] |
| C | Placebo comparator | Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: placebo |
| D | Experimental | Not described Receives: Drug: entecavir; Drug: peginterferon alfa-2a [Pegasys] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
Measured: 48 weeks after the end of treatment
Secondary outcomes (1)
Correlation early HBsAg response - response end of treatment/follow-up
Measured: every 6 weeks up to week 48, every 12 weeks therafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study start18 Sep 2010 (estimated)
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Why it stopped: This study was canceled for operational reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT01179594
- Sponsor's protocol ID
- MV22597
- Other IDs
- 2009-017602-36, 2009
- Status last verified
- Feb 2017
- First submitted
- 10 Aug 2010
- Last updated
- 17 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.
- ClinicalTrials.gov ID
- NCT01179594
- Acronym / sponsor ID
- MV22597
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was canceled for operational reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2010 (estimated)
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 11 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 randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is <500 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: peginterferon alfa-2a [Pegasys], Drug: placebo |
| B | Experimental | Drug: entecavir, Drug: peginterferon alfa-2a [Pegasys] |
| C | Placebo comparator | Drug: peginterferon alfa-2a [Pegasys], Drug: placebo |
| D | Experimental | Drug: entecavir, Drug: peginterferon alfa-2a [Pegasys] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, >/= 18 years of age
- chronic hepatitis B for >/= 6 months
- HBeAg negative at screening
- adequate renal function
Key exclusion criteria (5 listed)
- antiviral therapy for chronic hepatitis B within the previous 6 months
- hepatitis A, C, D or HIV infection
- treatment with systemic acyclovir or famciclovir within the previous 6 months
- decompensated liver disease (Childs B-C)
- history or evidence of a medical condition associated with chronic liver disease
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 |
|---|---|---|
| entecavir0.5 mg orally daily, 24 weeks (weeks 12-36) | Drug | B, D |
| peginterferon alfa-2a [Pegasys]180 mcg sc weekly, 48 weeks | Drug | A, B |
| peginterferon alfa-2a [Pegasys]180 mcg sc weekly, 96 weeks | Drug | C, D |
| placeboorally daily, 24 weeks (weeks 12-36) | Drug | A, C |
Primary outcome
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
Time frame: 48 weeks after the end of treatment
1 secondary outcome
Correlation early HBsAg response - response end of treatment/follow-up
Time frame: every 6 weeks up to week 48, every 12 weeks therafter
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 17 Feb 2017.
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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 4 study testing entecavir and peginterferon alfa-2a [Pegasys] in people with Hepatitis B, 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 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: withdrawn, as of the sponsor's last update on 17 Feb 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml) (time frame: 48 weeks after the end of treatment). 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 17 Feb 2017.