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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01958229
Other study ID # 200910027M
Secondary ID
Status Completed
Phase N/A
First received October 1, 2013
Last updated October 8, 2013
Start date December 2009
Est. completion date April 2013

Study information

Verified date October 2013
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

This study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR negativity.


Description:

This study will be multicenter, open-label and observational data collection of patients on telbivudine who meet baseline characteristics defined as the majority of patients seen in the clinic setting. Data collection will take place after enrollment, at Week 12, 24, 52, 76 and 104 for efficacy assessments. In patients who discontinue observational drug earlier, clinical information would be kept following for assessment as well.

Study purpose:

This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the Roadmap Concept in chronic hepatitis B treatment.

Objectives:

Primary:

To observe telbivudine's 2-year efficacy in real-world clinical setting of achieving HBV-DNA < 60 IU/ml and HBeAg seroconversion rate in patients with defined baseline characteristics and 24-week treatment PCR negativity as previously reported in GLOBE study's sub-analysis.

Secondary:

1. To observe the treatment outcomes.

2. To validate the result of super-responder trial.

3. To validate the Roadmap Concept.

Population:

The study population will consist of a representative group of 500 chronic hepatitis B patients with detectable HBsAg for more than 6 months who need telbivudine therapy based on investigators' judgment in 16 medical centers located in Taiwan.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date April 2013
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Male or female 18 to 65 years of age

- Documented chronic hepatitis B defined by ALL of following:

1. Clinical history compatible with compensated chronic hepatitis B

2. Detectable serum hepatitis B surface antigen (HBsAg)> 6 months and at the screening visit.

Exclusion Criteria:

- Pregnant or nursing

- co-infection with hepatitis C virus (HCV) or HIV

- Clinical or imaging diagnosis of cirrhosis

- Evidence of decreased renal function of creatinine >(=)2x ULN

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei City

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary PCR negativity week 52 No
Primary HBeAg seroconversion rate week 52 No
Primary PCR negativity week 104 No
Primary HBeAg seroconversion rate week 104 No
Secondary Rate of ALT normalization week 52 No
Secondary Genotypic resistance week 52 No
Secondary Rate of ALT normalization week 104 No
Secondary Genotypic resistance week 104 No
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