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

Hepatitis B, Chronic Clinical Trial

— POTENT  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01220596
• Other study ID #: ML25206
• Status: Recruiting
• Phase: Phase 3
• First received: October 13, 2010
• Last updated: July 1, 2011
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2011
• Source: Hanyang University
• Contact: Joo Hyun Sohn, MD, Ph.D
• Phone: +82-31-560-2225
• Email: sonjh[@]hanyang.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Entecavir and Pegylated interferon a-2a Sequential Treatment Group
Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon a-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks
• Pegylated interferon a-2a Monotreatment Group
Pegylated interferon a-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon	Gyeonggi-do
Korea, Republic of	Dong-A University Medical Center	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Dankook University Hospital	Cheonan	Chungcheongnam-do
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon-do
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Hanyang University Guri Hospital	Guri	Gyeonggi-do
Korea, Republic of	Jeju National University Hospital	Jeju	Jeju-do
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Kangnam Severance Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Kyunghee university Medical Center	Seoul
Korea, Republic of	Bundang CHA medical center	Sungnam	Gyeonggi-do
Korea, Republic of	Wonju Christian Hospital	Wonju	Gangwon-do
Korea, Republic of	Busan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University	Roche Pharma AG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBeAg seroconversion		24 weeks after treatment	No
Secondary	the change of HBsAg titer		24 weeks after treatment	No
Secondary	the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml		24 weeks after treatment	No
Secondary	The rate of serum HBV DNA < 300 copies		24 weeks after treatment	No
Secondary	The rate of ALT normalization		24 weeks after treatment	No
Secondary	The rate of HBsAg loss		24 weeks after treatment	No