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Hepatitis B clinical trials

View clinical trials related to Hepatitis B.

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NCT ID: NCT00362635 Completed - Hepatitis B Clinical Trials

Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection

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

The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.

NCT ID: NCT00362427 Completed - Hepatitis B Clinical Trials

Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®

Start date: August 2006
Phase: Phase 2
Study type: Interventional

PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3. Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar® Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.

NCT ID: NCT00362336 Completed - Hepatitis B Clinical Trials

Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

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

The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth. The secondary Objectives are: To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial. To describe Immunogenicity after the primary series and prior to and after a booster vaccination.

NCT ID: NCT00356564 Completed - Hepatitis B Clinical Trials

Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

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

Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine

NCT ID: NCT00354861 Completed - Healthy Clinical Trials

A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321

Start date: May 2005
Phase: Phase 1
Study type: Interventional

This is a single centre, three single administrations (Days 1, 29 and 57) at increasing doses of IMP321 (3, 10, 30 and 100 µg) in four cohorts of 12 subjects, single blind, randomized study.

NCT ID: NCT00354653 Completed - CHRONIC HEPATITIS B Clinical Trials

A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone

Start date: February 9, 2002
Phase: Phase 4
Study type: Interventional

The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited. Limited sustained response was observed post-treatment following a one year treatment period. Whether these results can be applied to patients in Iran is uncertain. This study is therefore intended to further assess the efficacy profile after two years of open treatment in the adult Iranian population.

NCT ID: NCT00352963 Completed - Hepatitis B Clinical Trials

Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

Start date: September 30, 2003
Phase: Phase 3
Study type: Interventional

This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.

NCT ID: NCT00348881 Completed - Influenza Clinical Trials

Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

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

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

NCT ID: NCT00347009 Completed - Cirrhosis Clinical Trials

Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis

Start date: May 2005
Phase: Phase 4
Study type: Interventional

This 36-month open-label study of adefovir dipivoxil investigates the clinical benefits of the therapy in chronic hepatitis B patients with advanced fibrosis or cirrhosis confirmed with biopsy. Primary endpoint is histological improvement defined as a decrease of Ishak Fibrosis Score by one point or more from baseline at Month 36 of adefovir dipivoxil treatment. Approximately 150 patients will be recruited in study centres in the Asia Pacific area. The patients are offered 36 months of open label adefovir dipivoxil treatment, with assessments every three months, after which there is a 6-month post study treatment follow-up prior to study completion. After the 36 months of study treatment, it is likely that the patient will benefit from continued treatment with adefovir dipivoxil. If this is the case in the investigators clinical judgement, the investigator should ensure that a routine prescription is available in a timely manner, and that no unnecessary interruption in treatment occurs.

NCT ID: NCT00343915 Completed - Hepatitis B Clinical Trials

Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

Start date: April 21, 2004
Phase: Phase 3
Study type: Interventional

To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course. Subjects were aged 11 to 15 years at the time of the primary vaccination course. At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.