Efficacy Study of Telbivudine in Chronic Hepatitis B Patients

Chronic Hepatitis B Clinical Trial

Official title:

A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958229
• Other study ID #: 200910027M
• 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

• 24-week PCR Negativity of Telbivudine
• Chronic Hepatitis B
• HBeAg Seroconversion Rate at 52 and 104 Week
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• PCR Negativity at 52 and 104 Week
• Roadmap Concept in Chronic Hepatitis B Treatment

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