Chronic Hepatitis BPhase 3NCT00048945
Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B
A Phase 3 study testing PEGASYS in people with Chronic Hepatitis B, run by Hoffmann-La Roche at 74 sites in 17 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- PEGASYS
- How many people
- 820 participants
- Where
- 74 sitesin 17 countries
- Study dates
- Jan 2002to Oct 2004
- 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
- Clinical diagnosis of hepatitis B
- Not pregnant
Who cannot join
- Treatment for hepatitis B in past 6 months
- Other hepatitis infections
- Severe liver disease
- Pregnancy
Trial locations and contacts
74 sites in 17 countries.
74 sites in 17 countries
United States15 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Atlanta, Georgia, 30308
Study site
Boston, Massachusetts, 02111
Study site
Cedar Creek, Texas, 78612
Study site
Chapel Hill, North Carolina, 27599-7080
Study site
Downey, California, 90242
Study site
Honolulu, Hawaii, 96817
Study site
Lincoln, Nebraska, 68501
Study site
Los Angeles, California, 90048
Study site
Minneapolis, Minnesota, 55404-4565
Study site
Pasadena, California, 91105
Study site
Salt Lake City, Utah, 84121
Study site
San Francisco, California, 94115
Study site
Scottsdale, Arizona, 85259
Study site
Seattle, Washington, 98195
China14 sites
Study site
Beijing, 100011
Study site
Beijing, 100034
Study site
Beijing, 100039
Study site
Beijing, 100050
Study site
Beijing, 100054
Study site
Chengdu, 610041
Study site
Chongqing, 400010
Study site
Guangzhou, 510515
Study site
Guangzhou, 510630
Study site
Hangzhou, 310003
Study site
Hong Kong
Study site
Shanghai, 200025
Study site
Shanghai, 200040
Study site
Shanghai, 200433
Germany6 sites
Study site
Berlin, 13353
Study site
Bochum, 44791
Study site
Cologne, 50931
Study site
Düsseldorf, 40225
Study site
Hanover, 30623
Study site
München, 81377
Taiwan6 sites
Study site
Kaohsiung City
Study site
Kwei Shan
Study site
Tainan
Study site
Taipei, 100
Study site
Taipei, 114
Study site
Taipei
Thailand5 sites
Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Bangkok, 10700
Study site
Chiang Mai, 50202
Study site
Songkhla, 90112
Brazil4 sites
Study site
Campinas, 13081-970
Study site
Porto Alegre, 90035-003
Study site
Salvador, 40150-130
Study site
São Paulo, 01246-900
South Korea4 sites
Study site
Seoul, 120-752
Study site
Seoul, 135-170
Study site
Seoul, 138-736
Study site
Seoul, 150-713
Canada3 sites
Study site
Calgary, Alberta, T2N 4N1
Study site
Toronto, Ontario, M5G 1L7
Study site
Toronto, Ontario, M5G 1X5
Israel3 sites
Study site
Haifa, 31096
Study site
Petah Tikva, 49100
Study site
Tel Aviv, 64239
Poland3 sites
Study site
Bialystok, 15-540
Study site
Bydgoszcz, 85-030
Study site
Warsaw, 01-201
Singapore3 sites
Study site
Singapore, 159402
Study site
Singapore, 169608
Study site
Singapore, 228510
About this study
The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.
- Conditions
- Chronic Hepatitis B
- Being tested
- PEGASYS
- 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.
PEGASYSDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2002 (estimated)
- Study startJan 2002
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048945
- Sponsor's protocol ID
- WV16240
- Status last verified
- Feb 2017
- First submitted
- 12 Nov 2002
- 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
- Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00048945
- Acronym / sponsor ID
- WV16240
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2002 (actual)
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 14 Nov 2002 (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.
The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of hepatitis B
- Not pregnant
Key exclusion criteria (4 listed)
- Treatment for hepatitis B in past 6 months
- Other hepatitis infections
- Severe liver disease
- Pregnancy
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 |
|---|---|---|
| PEGASYS | Drug | – |
Primary outcome
Not reported in the source record.
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 17 Feb 2017.
Related trials for Chronic Hepatitis B
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A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
The record lists no contact. Use the official record to reach the sponsor.
74 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEGASYS in people with Chronic Hepatitis B, run by Hoffmann-La Roche at 74 sites in 17 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 2 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, China, Germany, Taiwan, Thailand and 12 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 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 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.
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.