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Trial · Interventional

CompletedPhase 4Registry data

Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B

Overview

Status
Completed
Phase
Phase 4
Enrollment
52 participants (actual)
Sponsor
Seoul National University Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

South Korea

Start
Dec 2005
Primary completion
Aug 2008
Completion
Aug 2008
First posted
14 Feb 2006 (estimated)
Last update posted
21 Jul 2011 (estimated)
Conditions
Chronic Hepatitis B

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052006200720082009
  1. Ph 4

    Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B

    NCT00291616

    Dec 2005 to Aug 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Pegylated Interferon-alpha2aDrug
  • Thymosin alpha1 & Pegylated Interferon-alpha2aDrug

Arms2

  • Active comparator

    1

    Pegylated Interferon-alpha2a

  • Active comparator

    2

    Thymosin alpha1 \& Pegylated Interferon-alpha2a

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 48 week and 96 week

Secondary outcomes(1)
  1. Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs

    Time frame · 48 week and 96 week

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * the history of major organ transplantation * the history of medically uncontrolled thyroid disease * the history or sign of severe retinopathy

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