An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: telbivudine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis
Overall contact:
novartis, Phone: 41613241111
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: 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 outcome: Safety of patients switched from entecavir to telbivudine compared with patients continuing telbivudine assessed by Adverse Events, data of vital signs and other tests
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
novartis, Phone: 41613241111
Novartis Investigative Site, Seoul, Korea, Republic of; Recruiting
novartis, Phone: 41613241111
Novartis Investigative Site , (136-705), Seoul, Korea, Republic of; Recruiting
Novartis, Phone: 41613241111
Novartis Investigative Site , (405-760), In Cheon, Korea, Republic of; Recruiting
novartis, Phone: 41643241111
Novartis Investigative Site , (420-717), Gyeonggi-Do, Korea, Republic of; Recruiting
novartis, Phone: 41613241111
Novartis Investigative Site , (150-590), Seoul, Korea, Republic of; Recruiting
Novartis, Phone: 41613241111
Novartis Investigative Site (705-035), Daegu, Korea, Republic of; Recruiting
novartis, Phone: 41613241111
Additional Information
Starting date: April 2007
Last updated: July 13, 2009
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