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Hepatitis B clinical trials

View clinical trials related to Hepatitis B.

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NCT ID: NCT00432042 Completed - Hepatitis B Clinical Trials

Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)

Start date: January 12, 2007
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days following vaccination. Secondary Objectives: - To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix® hexa primary series schedule and all data are pooled. - To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data are pooled.

NCT ID: NCT00429481 Completed - Hepatitis B Clinical Trials

Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants

Start date: January 2001
Phase: Phase 2
Study type: Interventional

To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.

NCT ID: NCT00426712 Completed - Hepatitis B Clinical Trials

Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients

Start date: January 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and are expected to eventually go on hemodialysis.

NCT ID: NCT00423891 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection

Start date: June 30, 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied

NCT ID: NCT00414050 Completed - Hepatitis B Clinical Trials

A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants

Start date: September 2006
Phase: Phase 3
Study type: Interventional

This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine", to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B™).

NCT ID: NCT00412529 Completed - Hepatitis B Clinical Trials

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

Start date: December 2006
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00411697 Completed - Hepatitis B Clinical Trials

Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge

Start date: December 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00410202 Completed - Clinical trials for Hepatitis B, Chronic

Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus

DEFINE
Start date: March 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine

NCT ID: NCT00410072 Completed - Clinical trials for Hepatitis B, Chronic

Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B

Start date: April 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.

NCT ID: NCT00404651 Completed - Hepatitis B Clinical Trials

Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent. The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series. The secondary objectives are: - To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series - To assess the overall safety in each group one month after the third dose of the primary series.