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

NCT ID: NCT01829685

Last Updated: 2014-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy

Detailed Description

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Conditions

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Chronic Hepatitis B Inadequate Response Nucleos(t)Ide Analogues Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I

oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks

Group Type ACTIVE_COMPARATOR

Entecavir, Adefovir

Intervention Type DRUG

Group II

oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

Group Type ACTIVE_COMPARATOR

Entecavir, Adefovir

Intervention Type DRUG

Interventions

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Entecavir, Adefovir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who completed the 104-week Dragon study.
* Subjects who are willing to participate the extension study.

Exclusion Criteria

* Subjects who could not compliance with the protocol judged by investigators
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Major Science and Technology Special Project of China Eleventh Five-year

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinlin Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Friendship Hospital Attached To The Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Department of infectious disease, First Hospital of Peking University

Beijing, Beijing Municipality, China

Site Status

People's Hospital Under Beijnig University

Beijing, Beijing Municipality, China

Site Status

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status

The First People's Hospital of Foshan

Foshan, Guangdong, China

Site Status

Department of Infectious Disease, Nanfang Hospital

Guangzhou, Guangdong, China

Site Status

GuangDong Provincial People's hospital

Guangzhou, Guangdong, China

Site Status

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Xiangya Hospital Central-South Univrsity

Changsha, Hunan, China

Site Status

First Hospital .Jilin Unniversity

Changchun, Jilin, China

Site Status

ShengJing Hospital of China Medical University

Shengyang, Liaoning, China

Site Status

Changhai Hospital affiliated to Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Li Y, Pan CQ, Ji S, Yan G, Cheng J, Liu S, Xing H. Serum IL-21 levels predict HBeAg decline during rescue therapy in patients with partial response to nucleos(t)ide analogues. Exp Ther Med. 2021 Mar;21(3):216. doi: 10.3892/etm.2021.9648. Epub 2021 Jan 15.

Reference Type DERIVED
PMID: 33500704 (View on PubMed)

Other Identifiers

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MOH-06

Identifier Type: -

Identifier Source: org_study_id

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