Clinical trial NCT01958229: Efficacy Study of Telbivudine in Chronic Hepatitis B Patients
Official title: A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Roadmap Concept in Chronic Hepatitis B Treatment
24-week PCR Negativity of Telbivudine
PCR Negativity at 52 and 104 Week
HBeAg Seroconversion Rate at 52 and 104 Week
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic hepatitis B patients without cirrhosis

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: PCR negativity
timeFrame: week 52
measure: HBeAg seroconversion rate
timeFrame: week 52
measure: PCR negativity
timeFrame: week 104
measure: HBeAg seroconversion rate
timeFrame: week 104
Secondary outcomes:
measure: Rate of ALT normalization
timeFrame: week 52
measure: Genotypic resistance
timeFrame: week 52
measure: Rate of ALT normalization
timeFrame: week 104
measure: Genotypic resistance
timeFrame: week 104
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jia-Horng Kao, Professor
role: PRINCIPAL_INVESTIGATOR
References: