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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B; Chronic Hepatitis B

Intervention: Entecavir (Drug); Telbivudine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Mean Hepatitis B Virus (HBV) DNA Levels

Secondary outcome:

Change in Mean HBV DNA Level

The Area Under the Curve (AUC) of HBV DNA Change.

Change in Alanine Aminotransferase (ALT) Levels

Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance

Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss

Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production

Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female, 18-70 years of age with documented compensated hepatitis B "e"

antigen (HBeAg)-positive chronic hepatitis B

- Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

- Pregnant or breastfeeding

- Unwilling to use double barrier method of contraception

- Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human

immunodeficiency virus (HIV)

- Received Hepatitis B therapy in the past

- Use of immunomodulatory therapy in past 12 months

- History of or symptoms of hepatic decompensation or pancreatitis

- Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs

- Concurrent medication likely to preclude compliance with schedule of evaluations

- Use of other investigational drugs within 30 days of enrollment

- Abnormal laboratory values during screening

Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Holy Family Hospital_Bucheon, Bucheon,Kyunggi, Korea, Republic of

Inje University Busan Paik Hospital, Busan, Korea, Republic of

Yeungnam University Medical Center, Daegu, Korea, Republic of

Gachon Univ. Gil Medical Center Hospital, Incheon, Korea, Republic of

Asan Medical Center, Seoul, Korea, Republic of

Kangnam Sacred Heart Hospital, Seoul, Korea, Republic of

Korea University Medical Center_Anam, Seoul, Korea, Republic of

The Catholic University of Korea, Seoul, Korea, Republic of

Additional Information

Early Viral Kinetics of Telbivudine and Entecavir: Results of a 12-Week Randomized Exploratory Study with Patients with HBeAg-Positive Chronic Hepatitis B

Starting date: December 2006
Last updated: February 23, 2015

Page last updated: August 23, 2015

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