Clinical trial NCT00467545: An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Official title: An Extension to A Randomized, Open-label, Controlled, Multicenter, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine (LDT600) 600 mg or Entecavir (ETV) 0.5 mg Given Over 12 Weeks on the Kinetics of Hepatitis B Virus (HBV) DNA in Adults With HBeAg-positive, Compensated Chronic Hepatitis B (CHB) (An Open-label Multicenter, follow-on Trial of the Safety of Oral Administration of Telbivudine (LDT600) 600 mg Over 21 Months in Adults With HBeAg-positive Ompensated Chronic Hepatitis B (CHB))
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: HBeAg-positive
chronic hepatitis B
telbivudine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.


Eligibility criteria: Inclusion Criteria:

* The patient has completed the previous CLDT600A2407 study and is able to immediately enter this extension study with no study drug discontinuation
* Patient is willing and able to comply with the study drug regimen and all other study requirements
* The patient is willing and able to provide written informed consent to participate in the extension study.

Exclusion Criteria:

* Patient is pregnant or breastfeeding.
* Patient is co-infected with HCV, HDV, or HIV.
* History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Safety of telbivudine (LDT600) up to 21 additional months of open-label treatment in patients with chronic hepatitis B who have completed study CLDT600A2407 assessed by Adverse Events, data of vital signs and other tests
Secondary outcomes:
measure: Safety of patients switched from entecavir to telbivudine compared with patients continuing telbivudine assessed by Adverse Events, data of vital signs and other tests
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site (705-035)
city: Gyeonggi-Do
country: Korea, Republic of
facility: Novartis Investigative Site , (420-717)
city: In Cheon
country: Korea, Republic of
facility: Novartis Investigative Site , (405-760)
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site , (136-705)
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site , (150-590)
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: