Clinical trial NCT01220596: Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2010-10-14
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: HBeAg seroconversion
timeFrame: 24 weeks after treatment
Secondary outcomes:
measure: the change of HBsAg titer
timeFrame: 24 weeks after treatment
measure: the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml
timeFrame: 24 weeks after treatment
measure: The rate of serum HBV DNA < 300 copies
timeFrame: 24 weeks after treatment
measure: The rate of ALT normalization
timeFrame: 24 weeks after treatment
measure: The rate of HBsAg loss
timeFrame: 24 weeks after treatment
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
state: Chungcheongnam-do
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon-do
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
state: Gangwon-do
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
state: Gyeonggi-do
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Sungnam
country: Korea, Republic of
facility: Bundang CHA medical center
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: Busan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
state: Jeju-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee university Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Hanyang University
name: Joo Hyun Sohn, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jun DW, Ahn SB, Kim TY, Sohn JH, Kim SG, Lee SW, Kim BH, Kim DJ, Kim JK, Kim HS, Hwang SG, Choi WC, Tak WY, Lee HJ, Yoon KT, Yun BC, Lee SW, Baik SK, Park SH, Park JW, Park SJ, Lee JS. Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study). Chin Med J (Engl). 2018 Jul 20;131(14):1645-1651. doi: 10.4103/0366-6999.235880.