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A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon

16 augustus 2016 bijgewerkt door: Yonsei University

An Observational, Multi-Center, Cohort Study Evaluating the Antiviral Efficacy, Safety, and Tolerability in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon-alpha 2a (Pegasys®): TRACES STUDY

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  • Korea is known to be an endemic area for HBV infection. Some studies have reported that more than 95% of patients in Korea with chronic HBV have genotype C infection.
  • Compared with other genotypes, genotype C is associated with increased viral loads, higher histologic activity, more severe acute exacerbations, a longer viral clearance phase and worse antiviral response to peg-interferon therapy.
  • Long-term nucleos(t)ide analogue (NA) therapy is recommended for chronic hepatitis B (CHB) patients with compensated and decompensated liver disease. However, a possibility of cessation of antiviral treatment with oral NAs is unlikely due to rebound of HBV DNA levels after termination of NAs administration. In addition, NA therapy has been reported to have lower chance of HBsAg seroclearance compared to that with immunomodulatory agents such as peginterferon.
  • Pegasys® has been proved to induce HBsAg loss, which is the closest to cure of disease. However, a better understanding of HBV treatment with Pegasys® in the real-life clinical setting in Korea can be helpful for decision of treatment strategy in the future. Asian experience with Pegasys® therapy in CHB is limited. Study populations of investigator-initiated trials consist of selected group with smaller number of Korean patients. Therefore, long-term efficacy and safety data in real practice with Pegasys® treatment in both HBeAg-positive and -negative Korean patients are necessary.
  • In addition, the current proposed collected data study may be helpful to bring answers to many unresolved issues: the antiviral efficacy and safety profiles in Korean 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.

Studietype

Observationeel

Inschrijving (Werkelijk)

500

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Korea, republiek van
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, republiek van, 120-752
        • Sang Hoon Ahn

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Chronische hepatitis B
Geneesmiddel: pegylated Interferon-alpha 2a
Pegasys 180mcg/PFS/ subcutaneous injection / Once a week
Andere namen:
  • Pegasys

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
HBsAg loss or appearance of anti-HBs antibody in treatment-naïve Korean CHB patients treated with Pegasys
Tijdsspanne: 2015 (up to 3 years)
2015 (up to 3 years)

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Sustained suppression of HBV DNA
Tijdsspanne: 2015 (up to 3 years)
2015 (up to 3 years)
HBeAg loss and seroconversion in HBeAg-positive CHB
Tijdsspanne: 2015 (up to 3 years)
2015 (up to 3 years)
ALT normalization
Tijdsspanne: 2015 (up to 3 years)
2015 (up to 3 years)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yonsei University

Onderzoekers

  • Studie stoel: Sang Hoon Ahn, MD. PhD, Department of Internal Medicine, Yonsei Universtiy College of Medicine,

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2011

Primaire voltooiing (Werkelijk)

1 augustus 2014

Studie voltooiing (Werkelijk)

1 oktober 2014

Studieregistratiedata

Eerst ingediend

31 januari 2012

Eerst ingediend dat voldeed aan de QC-criteria

9 februari 2012

Eerst geplaatst (Schatting)

10 februari 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

17 augustus 2016

Laatste update ingediend die voldeed aan QC-criteria

16 augustus 2016

Laatst geverifieerd

1 augustus 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 4-2011-0461

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