NCT01531166

Brief Summary

The current proposed study aims to bring answers following issues: the antiviral efficacy and safety profiles in Korean Chronic Hepatitis B (CHB) patients who are mostly infected with solely genotype C HBV, a proper duration of Pegasys® therapy post-treatment durability or accumulation of HBeAg seroconversion/HBsAg loss, preventable effect on long-term disease progression to liver cirrhosis and liver cancer. In addition, this study aims to collect more data on the efficacy and safety in a real-life clinical setting of Pegasys® therapy in patients with CHB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

January 31, 2012

Last Update Submit

August 16, 2016

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis Bpegylated Interferon-alpha 2aKorean

Outcome Measures

Primary Outcomes (1)

  • HBsAg loss or appearance of anti-HBs antibody in treatment-naïve Korean CHB patients treated with Pegasys

    2015 (up to 3 years)

Secondary Outcomes (3)

  • Sustained suppression of HBV DNA

    2015 (up to 3 years)

  • HBeAg loss and seroconversion in HBeAg-positive CHB

    2015 (up to 3 years)

  • ALT normalization

    2015 (up to 3 years)

Study Arms (1)

Chronic hepatitis B

Drug: pegylated Interferon-alpha 2a

Interventions

pegylated Interferon-alpha 2aDRUG

Pegasys 180mcg/PFS/ subcutaneous injection / Once a week

Also known as: Pegasys
Chronic hepatitis B

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HBeAg-positive and HBeAg-negative chronic hepatitis B patients who have completed or are currently on Pegasys® monotherapy as a first line therapy. In addition, all consecutive CHB patients who will be initiated on Pegasys® in 2011 will be prospectively enrolled.

You may qualify if:

  • Adult subjects receiving treatment for CHB with PEGASYS according to standard of care and in line with the current summary of product characteristics(SPC)/ local labeling who have no contra-indication to PEGASYS therapy as per the local label.
  • Adult chronic hepatitis B patients (20 years of age or older) who has been completed or are currently receiving or are planned to receive Pegasys® as a first-line therapy.
  • Those with baseline HBV DNA \> 2,000 IU/mL and elevation of ALT level.
  • HBeAg positive or HBeAg negative serologically proven chronic hepatitis B(CHB)
  • Subjects treated with previous NAs therapy are eligible for this study.

You may not qualify if:

  • Subjects with ALT \> 10 x ULN or evidence of hepatocellular carcinoma.
  • Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
  • Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.
  • Subjects should have no other diseases that might be contraindication to peg-interferon therapy as per local SPC (e.g., severe psychiatric diseases, immunological diseases, severe retinopathy or thyroid dysfunction, history of severe pre-existing cardiac disease, etc)
  • Subjects with other contra-indications to PEGASYS therapy as detailed in the label (hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)
  • A history of liver transplantation or planned for liver transplantation
  • Subjects who receive concomitant therapy with telbivudine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sang Hoon Ahn

Seoul, Seodaemun-gu, 120-752, South Korea

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

  • Sang Hoon Ahn, MD. PhD

    Department of Internal Medicine, Yonsei Universtiy College of Medicine,

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 10, 2012

Study Start

September 1, 2011

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

KR(1)