Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

This study is currently recruiting participants.

Verified October 2012 by Nanfang Hospital of Southern Medical University

Sponsor:

Collaborator:

JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

Information provided by:

Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT01341743

First received: February 16, 2011

Last updated: April 26, 2013

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 16, 2011

Last Updated Date

April 26, 2013

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01341743 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

serum HBV DNA reduction from baseline at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
The proportion of subjects with ALT normalization at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
The proportion of subject with HBsAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

serum HBV DNA reduction from baseline at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
The proportion of subjects with ALT normalization at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
The proportion of subject with HBsAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
serum HBV DNA reduction from baseline at week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
serum HBV DNA reduction from baseline at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
serum HBV DNA reduction from baseline at week 36 [ Time Frame: week 36 ] [ Designated as safety issue: No ]
serum HBV DNA reduction from baseline at week 48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
serum HBV DNA reduction from baseline at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
serum HBV DNA reduction from baseline at week 64 [ Time Frame: week 64 ] [ Designated as safety issue: No ]
serum HBV DNA reduction from baseline at week 76 [ Time Frame: week 76 ] [ Designated as safety issue: No ]
serum HBV DNA reduction from baseline at week 88 [ Time Frame: week 88 ] [ Designated as safety issue: No ]
The proportion of subjects with ALT normalization at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
The proportion of subjects with ALT normalization at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
The proportion of subjects with HBeAg loss and seroconversion at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
The proportion of subject with HBsAg loss and seroconversion at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Official Title ^ICMJE

A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis B

Intervention ^ICMJE

Drug: Entecavir
patients will receive oral entecavir 1mg, daily for 104 weeks.
Drug: Entecavir, Adefovir
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Drug: Entecavir, Adefovir
patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

Study Arm (s)

Active Comparator: A
oral entecavir 1mg daily for 104 weeks

Intervention: Drug: Entecavir
Active Comparator: B
oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks

Intervention: Drug: Entecavir, Adefovir
Active Comparator: C
oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

Intervention: Drug: Entecavir, Adefovir

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

360

Estimated Completion Date

December 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female aged 18-65 years;
Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
Serum HBsAg positive and ALT<10ULN at study screening;
Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;

Exclusion Criteria:

History of viral breakthrough or genotypic resistance on previous therapy;
History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;
Other protocol defined exclusion criteria.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jinlin Hou, MD	86-20-61641941	jlhousmu@yahoo.com.cn
Contact: Jian Sun, MD	86-20-62787432	doctorsunjian@163.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01341743

Other Study ID Numbers ^ICMJE

MOH-04

Has Data Monitoring Committee

Yes

Responsible Party

Jinlin Hou, Nanfang Hospital

Study Sponsor ^ICMJE

Nanfang Hospital of Southern Medical University

Collaborators ^ICMJE

JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

Investigators ^ICMJE

Principal Investigator:

JinLin Hou, MD

Nanfang Hospital,Southern Medical University

Information Provided By

Nanfang Hospital of Southern Medical University

Verification Date

October 2012

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

To Top