NCT01794234

Brief Summary

This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

9 active sites

Status
terminated

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

August 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

February 15, 2013

Last Update Submit

November 1, 2016

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

  • Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)

    approximately 2.5 years

Secondary Outcomes (4)

  • HBs levels in correlation with treatment outcome

    approximately 2.5 years

  • For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)

    approximately 2.5 years

  • For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization

    approximately 2.5 years

  • Safety: Incidence of adverse events

    approximately 2.5 years

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic hepatitis B initiated on therapy with Pegasys

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Positive HBsAg for more than 6 months before assignment to treatment with Pegasys
  • Detectable HBV DNA (as measured by PCR)
  • HBeAg positive and negative patients
  • Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard
  • Elevated serum alanine aminotransferase (ALT)
  • Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation

You may not qualify if:

  • Contraindications to treatment with Pegasys according to the Summary of Product Characteristics
  • Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
  • Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment
  • Planned other than Pegasys antiviral treatment during Pegasys therapy
  • Chronic liver disease other than chronic hepatitis B
  • Pregnant or breast-feeding women
  • Inadequate hematologic function
  • Autoimmunology disorders
  • Co-infection with chronic hepatitis C or HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Bytom, 41-902, Poland

Location

Unknown Facility

Dębica, 39-200, Poland

Location

Unknown Facility

Gdansk, 80-214, Poland

Location

Unknown Facility

Krakow, 31-202, Poland

Location

Unknown Facility

Krakow, 31-501, Poland

Location

Unknown Facility

Mysłowice, 41-400, Poland

Location

Unknown Facility

Racibórz, 47-400, Poland

Location

Unknown Facility

Wroclaw, 51-149, Poland

Location

Unknown Facility

Łańcut, 37-100, Poland

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

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 DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 18, 2013

Study Start

August 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

PL(9)