Safety and Efficacy of Telbivudine on Liver Cirrhosis in... | NCT01380951

Studies
Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)

NCT01380951

Sponsor

The Fifth People's Hospital of Suzhou

Status

Unknown status

Last Update Posted

Jun 27, 2011Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Liver Cirrhosis
Chronic Hepatitis B

Interventions

telbivudine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jun 23, 2011

First Submission Date that Met QC Criteria

Jun 23, 2011

First Posted Date

Jun 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2011

Last Update Posted Date

Jun 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Detailed Description

Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
telbivudine	Experimental		Drug: telbivudine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
telbivudine	Drug	telbivudine 600mg/d 96 weeks	telbivudine	Sebivo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum HBV DNA	serum HBV DNA negativity and decline from baseline at week 48	48 weeks

Secondary Outcomes

Measure	Description	Time Frame
Serum HBeAg	rate of HBeAg seroconversion and HBeAg loss	48 weeks
Child-pugh score	the average decline of Child-pugh score at week 48 from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

liver cirrhosis with CHB
without history of antiviral therapy or discontinued antiviral therapy for more than 6 months
for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative
for patients with uncompensated liver cirrhosis:HBV DNA positive

Exclusion Criteria:

coinfection with HCV,HDV and HIV
AFP≥100mg/L or HCC diagnosed by iconography
with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chuanwu Zhu, Doctor	The Fifth People's Hospital of Suzhou	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Fifth People's Hospital of Suzhou	Recruiting	Suzhou	Jiangsu		China

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D019694	Hepatitis B, Chronic

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077712	Telbivudine

Ancestor Terms

ID	Term
D013936	Thymidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided