NCT00291616

Brief Summary

The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2005

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

July 21, 2011

Status Verified

July 1, 2011

Enrollment Period

2.7 years

First QC Date

February 13, 2006

Last Update Submit

July 20, 2011

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B, pegylated interferon, thymosin alpha

Outcome Measures

Primary Outcomes (1)

  • HBeAg seroconversion, HBV DNA titer<20,000 IU/mL

    48 week and 96 week

Secondary Outcomes (1)

  • Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs

    48 week and 96 week

Study Arms (2)

1

ACTIVE COMPARATOR

Pegylated Interferon-alpha2a

Drug: Pegylated Interferon-alpha2a

2

ACTIVE COMPARATOR

Thymosin alpha1 \& Pegylated Interferon-alpha2a

Drug: Thymosin alpha1 & Pegylated Interferon-alpha2a

Interventions

Pegylated Interferon-alpha2aDRUG

180 microgram s.c. injection weekly

1
Thymosin alpha1 & Pegylated Interferon-alpha2aDRUG

Pegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HBsAg positive and anti-HBs negative for more than 6 months
  • HBeAg positive
  • HBV DNA titer more than 100,000 IU/mL
  • serum ALT more than upper normal limit value, but no more than 10 times upper normal limit value

You may not qualify if:

  • the history of antiviral therapy for chronic hepatitis B within the recent 6 months
  • HAV IgM Ab + and/or HCV Ab + and/or HDV Ab and/or HIV Ab +
  • the sign of decompensated liver disease
  • the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
  • pregnant or lactating woman
  • neutrophil count less than 1,500/mm3 or platelet count less than 90,000/mm3
  • serum creatinine more than 1.5 times upper normal limit value
  • the sign of alcoholic or drug addiction within the recent 1 year
  • the history of psychotic disorder especially like depression
  • immunologically mediated disease
  • the history of esophageal varix
  • the history of severe heart disease or respiratory disease
  • the history of severe epilepsy or current use of antiepileptic drug
  • the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%
  • the history of systemic anticancer treatment including radiation therapy or immunotherapy including systemic corticosteroid
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Chongno-gu, 110-744, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2aThymalfasin

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

Intervention Hierarchy (Ancestors)

ThymosinThymus HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and ProteinsProteins

Study Officials

  • Jung H Yoon, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 14, 2006

Study Start

December 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 21, 2011

Record last verified: 2011-07

Locations

KR(1)