An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

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))

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467545
• Other study ID #: CLDT600AKR02
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2007
• Last updated: June 21, 2017
• Start date: April 2007
• Est. completion date: September 2009

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• telbivudine

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site (705-035)	Daegu
Korea, Republic of	Novartis Investigative Site , (420-717)	Gyeonggi-Do
Korea, Republic of	Novartis Investigative Site , (405-760)	In Cheon
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site , (136-705)	Seoul
Korea, Republic of	Novartis Investigative Site , (150-590)	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety of patients switched from entecavir to telbivudine compared with patients continuing telbivudine assessed by Adverse Events, data of vital signs and other tests

External Links

•   Clinical Trial Results for CLDT600AKR02 at Novartis Clinical Trials.com