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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. The completion date has passed and the status has not been verified in more than two years.
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
  Purpose

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

Condition Intervention Phase
Hepatitis B, Chronic
Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group
Drug: Pegylated interferon α-2a Monotreatment Group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hanyang University:

Primary Outcome Measures:
  • HBeAg seroconversion [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 228
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)
Active Comparator: Peginterferon alfa-2a monotherapy
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220596

Locations
Korea, Republic of
Dankook University Hospital
Cheonan, Chungcheongnam-do, Korea, Republic of, 330-715
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, Korea, Republic of, 200-704
Wonju Christian Hospital
Wonju, Gangwon-do, Korea, Republic of, 220-701
Soon Chun Hyang University Bucheon Hospital
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Hanyang University Guri Hospital
Guri, Gyeonggi-do, Korea, Republic of, 471-854
Bundang CHA medical center
Sungnam, Gyeonggi-do, Korea, Republic of, 463-712
Busan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, Korea, Republic of, 626-770
Jeju National University Hospital
Jeju, Jeju-do, Korea, Republic of, 690-767
Dong-A University Medical Center
Busan, Korea, Republic of, 602-103
Kosin University Gospel Hospital
Busan, Korea, Republic of, 602-702
Inje University Haeundae Paik Hospital
Busan, Korea, Republic of, 612-030
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Yeungnam University Medical Center
Daegu, Korea, Republic of, 705-717
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 110-746
Kyunghee university Medical Center
Seoul, Korea, Republic of, 130-702
Hanyang University Hospital
Seoul, Korea, Republic of, 133-791
Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of, 134-701
Kangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Inje University Sanggye Paik Hospital
Seoul, Korea, Republic of, 139-707
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Hanyang University
Roche Pharma AG
Investigators
Principal Investigator: Joo Hyun Sohn, MD, Ph.D Hanyang University
  More Information

Responsible Party: Joo Hyun Sohn / Professor, Hanyang University
ClinicalTrials.gov Identifier: NCT01220596     History of Changes
Other Study ID Numbers: ML25206 
Study First Received: October 13, 2010
Last Updated: July 1, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Peginterferon alfa-2a
Interferon-alpha
Entecavir
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016