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Hepatitis clinical trials

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NCT ID: NCT00207311 Completed - Hepatitis C Clinical Trials

Study for the Treatment of Significant Steatosis With Xenical Followed by Treatment of Hepatitis C With Pegasys/Copegus

HCVNASH
Start date: August 2005
Phase: Phase 4
Study type: Interventional

This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with histological evidence of > 33% hepatic steatosis or nonalcoholic steatohepatitis (NASH) and chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment naive) will be enrolled.

NCT ID: NCT00205075 Completed - Hepatitis C Clinical Trials

Impact of Moderate Alcohol Use on Hepatitis C Virus (HCV) Progression

Start date: August 2004
Phase: N/A
Study type: Observational

The purpose of this study is to determine the effect of moderate alcohol intake on liver disease caused by HCV in terms of speed of progression as compared to those not drinking alcohol.

NCT ID: NCT00203606 Completed - Hepatitis c Clinical Trials

Pegylated Interferon Plus Ribavirin in the Treatment of Active and Past Intravenous Drug Users Infected With Hepatitis C

Start date: January 2004
Phase: Phase 4
Study type: Interventional

Hepatitis C infects as many as 300,000 Canadians. Up to 25% of those infected will develop cirrhosis and be at risk for liver failure and liver cancer. Cirrhosis caused by hepatitis C is the most common reason for liver transplantation in Canada. The largest group of infected people are those who use injectable street drugs. However, people who continue to use drugs are routinely excluded from scientific studies testing new treatments for Hepatitis C and are generally recommended not to receive available treatments. Although several reasons are given to justify excluding these people from treatment, little scientific evidence is available to support it. We plan to examine how successful treatment with the current standard treatment of pegylated interferon and ribavirin is in those who continue to use injection drugs. We will compare the results of treatment of 70 active drug users to results of published clinical trials (this is a change from initial plan to compare to treatment results of 70 local) reformed drug users). Our goal is to determine whether reasonable success rates can be achieved in active drug users that would then further justify their routine treatment.

NCT ID: NCT00202839 Completed - Clinical trials for Hepatitis C, Chronic

Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)

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

This is an open-label, randomized, comparative, multicenter, 48-week study designed to evaluate the efficacy and safety of combination treatment with pegylated interferon and ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24 weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects will be randomly assigned to one of two study groups. One group will be followed for an additional 48 weeks without study medication, while the other will be continuously treated for an additional 24 weeks and then followed for another 24 weeks without study medication. Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the follow-up period, will be measured along with other outcomes.

NCT ID: NCT00200343 Completed - Chronic Hepatitis C Clinical Trials

Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C

Start date: July 2002
Phase: Phase 3
Study type: Interventional

This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.

NCT ID: NCT00199732 Completed - Chronic Hepatitis B Clinical Trials

Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a

DNA-EVAL
Start date: December 2004
Phase: N/A
Study type: Observational

Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver. Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment. The major interest of this marker is that it can be measured by a simple blood test instead of a liver biopsy.

NCT ID: NCT00199719 Completed - Chronic Hepatitis C Clinical Trials

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

CINAM
Start date: June 2003
Phase: Phase 2
Study type: Interventional

Peg interferon and ribavirin currently represent the standard approved association for treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is expected to gain about 10 % of sustained virological response (SVR) . Unfortunately, about 50 % of the patients remain relapsers or virological non responders. The main predictive factors of SVR are HCV genotype and body weight (BW). The impact of the drug pharmacological properties, particularly those of ribavirin requires complementary studies. This drug has a large distribution volume and its concentrations display large inter-individual variability. Two studies performed in HCV patients found no correlation between ribavirin dose adjusted on BW and a single ribavirin time point serum concentration at steady state. The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of ribavirin in hepatitis C patient

NCT ID: NCT00197275 Completed - Hepatitis B Clinical Trials

Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants

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

The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.

NCT ID: NCT00197249 Completed - Hepatitis A Clinical Trials

Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & Immunogenicity

Start date: May 2002
Phase: Phase 3
Study type: Interventional

To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the concomitant administration of Typherix and Havrix, and when compared to the administration of monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the first dose of the study vaccine.

NCT ID: NCT00197236 Completed - Hepatitis A Clinical Trials

Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

Start date: November 11, 2003
Phase: Phase 3
Study type: Interventional

This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.