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

This study is currently recruiting participants.

Verified June 2011 by Hanyang University

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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 13, 2010

Last Updated Date

July 1, 2011

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01220596 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatitis B, Chronic

Intervention ^ICMJE

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)

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

228

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01220596

Other Study ID Numbers ^ICMJE

ML25206

Has Data Monitoring Committee

Yes

Responsible Party

Joo Hyun Sohn / Professor, Hanyang University

Study Sponsor ^ICMJE

Hanyang University

Collaborators ^ICMJE

Roche Pharma AG

Investigators ^ICMJE

Principal Investigator:

Joo Hyun Sohn, MD, Ph.D

Hanyang University

Information Provided By

Hanyang University

Verification Date

June 2011

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

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