Hepatitis B, ChronicPhase 1NCT00962871
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
A Phase 1 study testing peginterferon alfa-2a [Pegasys] and tenofovir in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 6 sites in 4 countries.
Trial summary
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- peginterferon alfa-2a [Pegasys] and tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Aug 2009to Feb 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male adults of Southeast and/or East Asian origin, 18-55 years of age
- HBeAg-positive chronic hepatitis B
- detectable HBV DNA
Who cannot join
- prior antiviral therapy for chronic hepatitis B
- evidence of bridging fibrosis, cirrhosis or decompensated liver disease
- positive test at screening for HAV (IgM), HCV, HDV or HIV
- history or evidence of medical condition associated with chronic liver disease
- antineoplastic or immunomodulatory treatment </=6 months prior to first dose of study drug
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States2 sites
Study site
Los Angeles, California, 90036
Study site
San Francisco, California, 94143-0538
About this study
Official title: An Open-label, Randomized Study to Evaluate the Acute Immunologic Responses in Asian Subjects With E Antigen Positive Chronic Hepatitis B Following Initiation of Therapy for Hepatitis B With Pegasys, Nucleoside Analogues, or Both.
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is <50.
- Conditions
- Hepatitis B, Chronic
- Being tested
- peginterferon alfa-2a [Pegasys], tenofovir
- 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.
peginterferon alfa-2a [Pegasys]Drug
360 micrograms sc/week for 2 weeks
tenofovirDrug
300mg po daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: tenofovir |
| 2 | Experimental | Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: tenofovir |
| 3 | Experimental | Not described Receives: Drug: peginterferon alfa-2a [Pegasys] |
| 4 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Viral Quantitative e Antibody
An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.
Measured: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
Secondary outcomes (2)
Mean Change From Baseline in HBV-DNA log10
An acute virologic response was determined by change from baseline in HBV-DNA log10.
Measured: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
Early Changes in Viral Sequence Associated With Viral Suppression
Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.
Measured: Day 1, 5, 14, Week 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00962871
- Sponsor's protocol ID
- PP22512
- Status last verified
- Jan 2016
- First submitted
- 19 Aug 2009
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Mehrotra A, D'Angelo JA, Romney-Vanterpool A, Chu T, Bertoletti A, Janssen HLA, Gehring AJ. IFN-alpha Suppresses Myeloid Cytokine Production, Impairing IL-12 Production and the Ability to Support T-Cell Proliferation. J Infect Dis. 2020 Jun 16;222(1):148-157. doi: 10.1093/infdis/jiaa064.
PubMed 32049318Hong LZ, Hong S, Wong HT, Aw PP, Cheng Y, Wilm A, de Sessions PF, Lim SG, Nagarajan N, Hibberd ML, Quake SR, Burkholder WF. BAsE-Seq: a method for obtaining long viral haplotypes from short sequence reads. Genome Biol. 2014;15(11):517. doi: 10.1186/PREACCEPT-6768001251451949.
PubMed 25406369
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Study to Evaluate the Acute Immunologic Responses in Asian Subjects With E Antigen Positive Chronic Hepatitis B Following Initiation of Therapy for Hepatitis B With Pegasys, Nucleoside Analogues, or Both.
- ClinicalTrials.gov ID
- NCT00962871
- Acronym / sponsor ID
- PP22512
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 20 Aug 2009 (estimated)
- Results
- Posted 13 Jan 2016
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, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is <50.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: tenofovir |
| 2 | Experimental | Drug: peginterferon alfa-2a [Pegasys], Drug: tenofovir |
| 3 | Experimental | Drug: peginterferon alfa-2a [Pegasys] |
| 4 | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male adults of Southeast and/or East Asian origin, 18-55 years of age
- HBeAg-positive chronic hepatitis B
- detectable HBV DNA
Key exclusion criteria (5 listed)
- prior antiviral therapy for chronic hepatitis B
- evidence of bridging fibrosis, cirrhosis or decompensated liver disease
- positive test at screening for HAV (IgM), HCV, HDV or HIV
- history or evidence of medical condition associated with chronic liver disease
- antineoplastic or immunomodulatory treatment </=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]360 micrograms sc/week for 2 weeks | Drug | 2, 3 |
| tenofovir300mg po daily for 2 weeks | Drug | 1, 2 |
Primary outcome
Mean Change From Baseline in Viral Quantitative e Antibody
Time frame: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.
2 secondary outcomes
Mean Change From Baseline in HBV-DNA log10
Time frame: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
Early Changes in Viral Sequence Associated With Viral Suppression
Time frame: Day 1, 5, 14, Week 4 and 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32049318Mehrotra A, D'Angelo JA, Romney-Vanterpool A, Chu T, Bertoletti A, Janssen HLA, Gehring AJ. IFN-alpha Suppresses Myeloid Cytokine Production, Impairing IL-12 Production and the Ability to Support T-Cell Proliferation. J Infect Dis. 2020 Jun 16;222(1):148-157. doi: 10.1093/infdis/jiaa064.
- Derived from this study: PubMed 25406369Hong LZ, Hong S, Wong HT, Aw PP, Cheng Y, Wilm A, de Sessions PF, Lim SG, Nagarajan N, Hibberd ML, Quake SR, Burkholder WF. BAsE-Seq: a method for obtaining long viral haplotypes from short sequence reads. Genome Biol. 2014;15(11):517. doi: 10.1186/PREACCEPT-6768001251451949.
- This report describes the early effects of IFNα treatment on immune and viral biomarkers in HBeAg+ CHB patients. The results show that PegIFNα-induced innate immune activation directly benefits from the suppression of HBV replication.Link provided by the sponsor.
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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
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing peginterferon alfa-2a [Pegasys] and tenofovir in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 6 sites in 4 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 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Singapore, New Zealand, Taiwan. 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 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?
Yes. Results are posted in the registry (first posted 13 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Viral Quantitative e Antibody (time frame: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)). 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 NCT00962871, which also lists 2 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 8 Feb 2016.