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Hepatitis B, ChronicPhase 4NCT00435825

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).

A Phase 4 study testing peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 55 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with 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?
peginterferon alfa-2a [Pegasys]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
551 participants
Where
55 sitesin 13 countries
Study dates
Mar 2007to Dec 2010
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients, >=18 years of age;
  • positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA >500,000 copies/mL, and anti-HBs negative;
  • liver disease consistent with Chronic Hepatitis B.

Who cannot join

  • antiviral therapy for CHB within previous 6 months;
  • co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV) or Human immuno deficiency virus (HIV);
  • evidence of decompensated liver disease;
  • medical condition associated with chronic liver disease.

Trial locations and contacts

55 sites in 13 countries.

55 sites in 13 countries

United States10 sites

  • Study site

    Atlanta, Georgia, 30306

  • Study site

    Flushing, New York, 11355

  • Study site

    Los Angeles, California, 90095

  • Study site

    Palo Alto, California, 94304-1509

  • Study site

    Philadelphia, Pennsylvania, 19141

  • Study site

    Portland, Oregon, 97227

  • Study site

    Richmond, Virginia, 23249

  • Study site

    San Diego, California, 92105

  • Study site

    San Francisco, California, 94115

  • Study site

    San Jose, California, 95116

Other trials in United States

China6 sites

  • Study site

    Beijing, 100050

  • Study site

    Beijing, 100054

  • Study site

    Guangzhou, 510630

  • Study site

    Hunan, 410008

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 201508

Other trials in China

France6 sites

  • Study site

    Clichy, 92118

  • Study site

    Montpellier, 34295

  • Study site

    Nice, 06202

  • Study site

    Strasbourg, 67091

  • Study site

    Toulouse, 31078

  • Study site

    Villejuif, 94804

Other trials in France

Brazil5 sites

  • Study site

    Campinas, 13081-970

  • Study site

    Ribeirão Preto, 14049-900

  • Study site

    Salvador, 40150-130

  • Study site

    Santo André, 09060-650

  • Study site

    São Paulo, 05403-000

Other trials in Brazil

Germany5 sites

  • Study site

    Berlin, 13353

  • Study site

    Cologne, 50937

  • Study site

    Frankfurt am Main, 60590

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Hanover, 30625

Other trials in Germany

Thailand5 sites

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Chiang Mai, 50202

  • Study site

    Khon Kaen, 40002

  • Study site

    Songkhla, 90112

Other trials in Thailand

Russia4 sites

  • Study site

    Saint Petersburg, 190103

  • Study site

    Samara, 443021

  • Study site

    Smolensk, 214006

  • Study site

    Stavropol, 355017

Other trials in Russia

Australia3 sites

  • Study site

    Fitzroy, 3065

  • Study site

    Greenslopes, 4120

  • Study site

    Woolloongabba, 4102

Other trials in Australia

South Korea3 sites

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 138-736

Other trials in South Korea

Taiwan3 sites

  • Study site

    Kaohsiung City, 807

  • Study site

    Taipei, 100

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Hong Kong2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Hong Kong

Other trials in Hong Kong

New Zealand2 sites

  • Study site

    Auckland, 100

  • Study site

    Hamilton

Other trials in New Zealand

Singapore1 site

  • Study site

    Singapore, 169608

Other trials in Singapore

About this study

Official title: A Randomized, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.

This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Being tested
peginterferon alfa-2a [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.

  • peginterferon alfa-2a [Pegasys]Drug

    90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.

Study groups in NCT00435825
Study groupRoleWhat they receive
peginterferon alfa-2a 90 μg_24 WeeksExperimentalParticipants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
Receives: Drug: peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a 180 μg_24 WeeksExperimentalParticipants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
Receives: Drug: peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a 90 μg_48 WeeksExperimentalParticipants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
Receives: Drug: peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a 180 μg_48 WeeksExperimentalParticipants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
Receives: Drug: peginterferon alfa-2a [Pegasys]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment

    Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Secondary outcomes (11)

  1. Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72

    Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72.

    Measured: Week 72

  2. Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment

    Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

  3. Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment

    HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment.

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

  4. Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment

    Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

  5. Percentage of Participants With Normal Alanine Aminotransferase (ALT)

    Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

  6. Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment

    Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of < 20,000 IU/mL (Less than 100,000 copies/mL) is reported.

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

  7. Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment

    Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of < 2,000 IU/mL (Less than 10,000 copies/mL) is reported.

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)

  8. Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment

    Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

  9. Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment

    Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA <2,000 IU/ml (Less than 10,000 copies/mL).

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

  10. Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment

    Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

  11. Quantitative HBV-DNA 24 Weeks Following End of Treatment

    Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.

    Measured: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
551 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00435825
Sponsor's protocol ID
WV19432
Status last verified
Jun 2013
First submitted
15 Feb 2007
Last updated
25 Jun 2013

Publications

  • Liaw YF, Jia JD, Chan HL, Han KH, Tanwandee T, Chuang WL, Tan DM, Chen XY, Gane E, Piratvisuth T, Chen L, Xie Q, Sung JJ, Wat C, Bernaards C, Cui Y, Marcellin P. Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C. Hepatology. 2011 Nov;54(5):1591-9. doi: 10.1002/hep.24555.

    PubMed 22045673

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 55 sites in 13 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 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 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, China, France, Brazil, Germany and 8 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 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?

Yes. Results are posted in the registry (first posted 25 Jun 2013). 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?

Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment (time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)). 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 NCT00435825, 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 25 Jun 2013.

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