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Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B. (POTENT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hanyang University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Hanyang University
ClinicalTrials.gov Identifier:
NCT01220596
First received: October 13, 2010
Last updated: July 1, 2011
Last verified: June 2011

October 13, 2010
July 1, 2011
June 2010
June 2013   (final data collection date for primary outcome measure)
HBeAg seroconversion [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01220596 on ClinicalTrials.gov Archive Site
  • the change of HBsAg titer [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
  • the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
  • The rate of serum HBV DNA < 300 copies [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
  • The rate of ALT normalization [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
  • The rate of HBsAg loss [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.
A Randomized, Multi Center, Phase IIIb Open-label Study to Evaluate the Efficacy of Sequential Therapy of Peginterferon Alfa-2a(Pegasys(TM)) Following Entercavir Compared With Peginterferon Alfa-2a Monotherapy in Patient With HBeAg Positive Chronic Hepatitis B.

Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B.

  • Increased HBeAg seroconversion rate
  • Increased HBsAg loss rate
  • To define the best treatment condition for chronic HBV hepatitis patients
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
  • Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group
    Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks
    Other Names:
    • Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM)
    • Generic/Brand name: Entecavir/Baraclude(TM)
  • Drug: Pegylated interferon α-2a Monotreatment Group
    Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
    Other Name: Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM)
  • Experimental: Sequential therapy
    Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks
    Intervention: Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group
  • Active Comparator: Peginterferon alfa-2a monotherapy
    Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
    Intervention: Drug: Pegylated interferon α-2a Monotreatment Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
228
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA > 100,000 copies/ml and anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN.

Exclusion Criteria:

  • Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.
Both
18 Years and older
No
Contact: Joo Hyun Sohn, MD, Ph.D +82-31-560-2225 sonjh@hanyang.ac.kr
Contact: Dae-Won Jun, MD, Ph.D +82-2-2290-8338 noshin@hanyang.ac.kr
Korea, Republic of
 
NCT01220596
ML25206
Yes
Joo Hyun Sohn / Professor, Hanyang University
Hanyang University
Roche Pharma AG
Principal Investigator: Joo Hyun Sohn, MD, Ph.D Hanyang University
Hanyang University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP