- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00537537
To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)
An Open Label, Response Adaptive Study of Telbivudine in Adults With HBeAg Positive Compensated CHB
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Hyderabad, India
- Novartis Investigative Site
-
Mumbai, India
- Novartis Investigative Site
-
Vellore, India
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Male or female, at least 18 yrs of age; HBsAg positive, HBeAg positive and anti-HBe negative at the time of screening; Quantifiable serum HBV DNA levels of >105copies/ml; ALT levels any level; Treatment naïve; Baseline liver histology in case of ALT levels within normal limits performed within last 12 months) indicative of chronic hepatitis B changes Metavir score F >2; Willing and able to comply with the study drug regimen and all other study requirements; The patient or guardian is willing and able to explore written informed consent to participate in the study. Exclusion Criteria:
Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) at Screening visit; Patient is of childbearing potential (men and women) and unwilling to use a barrier method of contraception. It is required that a barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of childbearing potential (men and women) regardless of whether a hormonal agent also is used as a method of contraception; Patient is co infected with hepatitis C virus (HCV), HIV. Patients will be tested for antibodies to HCV & HIV in the Screening assessments;Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir; Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years; Patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids; Patients who has been on warfarin or other anticoagulants during 30 days prior to screening or if expected during the present study; Patient has any other concurrent medical condition, at clinician's discretion, likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study Other protocol defined inclusion/exclusion criteria may apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Telbivudine
|
|
Active Comparator: 2
Telbivudine
|
|
Active Comparator: 3
Telbivudine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Antiviral efficacy with adefovir combination assessed by HBV DNA non-detectability (PCR <300 copies/ml) by week 104.
|
Secondary Outcome Measures
Outcome Measure |
---|
Antiviral efficacy with telbivudine alone assessed by HBV DNA non-detectability (PCR <300 copies/ml) at week 24 and 36.
|
HBeAg loss & HBeAg seroconversion (defined as a loss of HBeAg and a gain of detectable level of HBeAb).
|
Alanine Transaminase (ALT) normalization, in patients with raised levels at baseline.
|
Change in HBV DNA level (log10 copies/ml) from baseline to week 4, 8, 12, 24, 36, 52, 76 and 104.
|
Viral breakthrough, defined as increase of HBV DNA by 1 log10 copies/ml from treatment nadir, at any point after week 24.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Telbivudine
Other Study ID Numbers
- CLDT600AIN01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis B, Chronic
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Tongji HospitalGilead SciencesRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Changhai HospitalCompleted
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
-
Zhongshan Hospital Xiamen UniversityUnknownHealthy | Chronic Hepatitis B InfectionChina
-
Brii Biosciences LimitedVir Biotechnology, Inc.Active, not recruitingChronic Hepatitis B Virus InfectionSingapore, Thailand, Australia, China, Korea, Republic of
-
National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu Chi... and other collaboratorsRecruitingChronic Hepatitis b | Hepatitis B ReactivationTaiwan
-
Mahidol UniversityUnknownChronic Hepatitis B, HBsAg, Hepatitis B VaccineThailand
Clinical Trials on Telbivudine
-
Nanfang Hospital of Southern Medical UniversityNovartis; Major Science and Technology Special Project of China Eleventh Five-yearUnknown
-
Novartis PharmaceuticalsCompletedAn Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis BChronic Hepatitis BKorea, Republic of
-
Chang Gung Memorial HospitalCompletedVirus Diseases | Disorder Related to Transplantation | Injury Due to Exposure to External Cause
-
Beijing Ditan HospitalUnknownImmune Globulin, Prophylaxis, Telbuvidine, Vaccine
-
Yonsei UniversityUnknownChronic Hepatitis BKorea, Republic of
-
Nanfang Hospital of Southern Medical UniversityNovartis; Major Science and Technology Special Project of China Eleventh Five-yearCompleted
-
Southeast University, ChinaCompletedChronic Hepatitis B | Pregnancy Complications | High Viral Load | Elevated Alanine Aminotransferase LevelsChina
-
Novartis PharmaceuticalsCompletedChronic Hepatitis BBelgium, Germany, United Kingdom, Philippines
-
NovartisNovartis PharmaceuticalsCompletedHepatitis BHong Kong, Singapore, New Zealand
-
Novartis PharmaceuticalsWithdrawnCompensated Chronic Hepatitis BUnited States, Puerto Rico