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Hepatitis B, ChronicPhase 3NCT01237496

Analysis of HBV-Specific Immune Response in Patients With HBeAg Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a (40KD)) - Immunology Sub-Study of ML18253

A Phase 3 study testing peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 5 sites in Italy.

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 study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
peginterferon alfa-2a [Pegasys]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
5 sitesItaly
Study dates
Jul 2005to Sep 2009
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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients 18-55 years of age
  • Chronic HBeAg negative hepatitis B
  • Liver disease consistent with chronic hepatitis documented by liver biopsy within 18 months prior to enrollment
  • Participation in study ML18253.

Who cannot join

  • Interferon-based or any systemic anti-HBV therapy </= 12 months prior to first dose of study drug
  • Antiviral, anti-neoplastic, or immunomodulatory treatment </= 12 months prior to first dose of study drug
  • Nonresponders to previous interferon therapy and resistant to lamivudine
  • Co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV)
  • Hepatocellular cancer
  • Compensated (Child A, score 6) or decompensated liver disease (Child B or C)
  • History or evidence of medical condition associated with chronic liver disease other than HBV

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Italy5 sites

  • Study site

    Bologna, 40138

  • Study site

    Brescia, 25125

  • Study site

    Milan, 20122

  • Study site

    Parma, 43100

  • Study site

    Reggio Emilia, 42100

Other trials in Italy

About this study

Official title: Longitudinal Analysis of HBV-specific T Cell Responses in Patients With HBeAg-negative Chronic Hepatitis B (CHB) Treated With Pegylated Interferon Alfa-2a (40 KD) (Pegasys - RO258310). Immunology Sub-study of ML18253

This study will evaluate immune responses in patients with HBeAg-negative chronic Hepatitis B treated with Pegasys (peginterferon alfa-2a). Eligible patients will have been randomized in study ML18253 to receive Pegasys 180 mcg subcutaneously for 48 or 96 weeks. Sample collection period for each patients will occur in the first 24 weeks.

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

    180 mcg sc weekly

Study groups in NCT01237496
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: peginterferon alfa-2a [Pegasys]

What is being measured

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

  1. CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry)

    Measured: 24 weeks

  2. CD4 and CD8 mediated immune response: Interleukin-2 production (Flow cytometry)

    Measured: 24 weeks

  3. CD4 and CD8 mediated immune response: Cytokine profile analysis by supernatant culture

    Measured: 24 weeks

  4. CD4 and CD8 mediated immune response: Proliferative response upon T-cell stimulation

    Measured: 24 weeks

  5. CD8 response in HLA-A2 positive patients

    Measured: 24 weeks

Secondary outcomes (2)

  1. Profile of proinflammatory cytokines: analysis of cytokines in serum

    Measured: 24 weeks

  2. HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)

    Measured: 24 weeks

Timeline

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

  1. First posted9 Nov 2010 (estimated)
  2. Study startJul 2005
  3. Primary completionSep 2009
  4. Study completionSep 2009

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01237496
Sponsor's protocol ID
ML18675
Status last verified
Nov 2016
First submitted
8 Nov 2010
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 5 sites in Italy.

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 7 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. 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.

What does the primary outcome measure?

CD4 and CD8 mediated immune response: Interferon-y (ELISPOT analysis, flow cytometry) (time frame: 24 weeks). The study lists 5 primary outcomes in all. 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 NCT01237496.

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 2 Nov 2016.

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