NCT01237496

Brief 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. Sample collection period for each patients will occur in the first 24 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2005

Typical duration for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4.2 years

First QC Date

November 8, 2010

Last Update Submit

November 1, 2016

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (5)

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

    24 weeks

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

    24 weeks

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

    24 weeks

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

    24 weeks

  • CD8 response in HLA-A2 positive patients

    24 weeks

Secondary Outcomes (2)

  • Profile of proinflammatory cytokines: analysis of cytokines in serum

    24 weeks

  • HBV viremia (HBV RNA assessed by COBAS PaqMan HCV test)

    24 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: peginterferon alfa-2a [Pegasys]

Interventions

peginterferon alfa-2a [Pegasys]DRUG

180 mcg sc weekly

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Brescia, 25125, Italy

Location

Unknown Facility

Milan, 20122, Italy

Location

Unknown Facility

Parma, 43100, Italy

Location

Unknown Facility

Reggio Emilia, 42100, Italy

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 9, 2010

Study Start

July 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

IT(5)