Phase 4 Hepatitis B Trial, Completed NCT00927082 Sponsor: Hoffmann-La Roche Condition: Hepatitis B
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 383 adults across four treatment groups, all receiving a medication called pegylated interferon (PEG-IFN) for hepatitis B. The groups differed by dose (90 micrograms or 180 micrograms) and by how long they received treatment (24 weeks or 48 weeks). The main thing the trial was measuring was a change in a hepatitis B marker in the blood called HBeAg — specifically, whether it disappeared and was replaced by a protective antibody (called anti-HBe), a process known as "seroconversion." Several other blood markers related to hepatitis B and liver health were also tracked. Between 320 and 320 participants completed the study out of 383 who started, with dropout numbers ranging from 10 to 22 across the four groups. The reported data shows that for the primary measure — HBeAg seroconversion — the percentage of participants who reached this milestone varied by group and by the point in time it was measured. Results were recorded at the end of treatment, at 24 weeks after treatment ended, and at 48 weeks after treatment ended. By the final follow-up point (48 weeks after treatment), the reported figures were: 26.9% in the 90mcg/24-week group, 37.1% in the 180mcg/24-week group, 30.2% in the 90mcg/48-week group, and 47.4% in the 180mcg/48-week group. For the secondary measures, the reported data shows similar patterns across groups. For example, the percentage of participants whose liver enzyme levels (ALT — a marker sometimes used to assess liver stress) returned to a normal range by the final follow-up were 58.1%, 60.7%, 55.7%, and 65.3% respectively. Changes in another surface marker (HBsAg seroconversion) were reported at low percentages across all groups, generally between 0% and 3.2% at the final follow-up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Hepatitis B Trial, Completed

NCT00927082
Completed Phase 4 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must have given your informed consent to participate in the related study called WV19432
  • You must have already completed both the treatment and the follow-up period in study WV19432

Who may not be able to join:

  • Anyone who would not have been eligible for the original study WV19432 may also not be eligible for this trial (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Australian sites

, Fitzroy, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 April 2009
Est. completion
1 November 2014

Where this trial is recruiting

🇦🇺 Australia 🇧🇷 Brazil 🇨🇳 China Hong Kong 🇳🇿 New Zealand 🇷🇺 Russia 🇸🇬 Singapore 🇰🇷 South Korea 🇹🇼 Taiwan 🇹🇭 Thailand

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.; Percentage of Participants With HBsAg Loss

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov