Clinical Trials for Hepatitis A

Clinical trials are research studies conducted in an effort to improve overall patient health and care. Each trial involves running supervised tests to determine the effectiveness and safety of new drugs, procedures and/or devices with the aim of answering scientific questions about a disease or condition. Risks and side-effects are also evaluated during these trials with results ranging from being unpleasant, with side effects such as headaches, to more serious or even life-threatening risks. A clinical trial may be separated into phases, or steps, with each step designed to answer a separate research question. This maybe reflected in the trial name.

A brief description of each phase:

• Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients.
• Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety.
• Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety.
• Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

Clinical Trials data for Hepatitis A is grouped into the following categories:-

• View by trial name
• View by drugs used in Hepatitis A clinical trials

Clinical Trials by trial name

The format for each of the following is:

• The name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.
• followed by a list of drug/s, if any, used in the trial

ClinicalTrials.gov has listed the following trials for Hepatitis A:

• Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children - This study has been completed (Current: 23 Nov 2006)
• A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A - This study has been completed (Current: 23 Nov 2006)
• Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella, and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month Old Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age - This study has been terminated (Current: 23 Nov 2006)
• Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Measles/Mumps/Rubella Vaccine & a Varicella (Chickenpox) Vaccine in Healthy Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• LT FU Studies at Y6,7 8,9,10: 2 Formulations of Combined hepatitisA/B Vaccine Compared in Subjects Aged 12-15 y - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Long Term Follow-up Studies at Yrs 2,3,4 & 5, Where 2 Formulations of the Combined Hepatitis A & B Vaccine Was Compared - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Diphtheria, Tetanus & Pertussis Vaccine (DTaP) Vaccine & a Haemophilus Influenza Type B (Hib) Vaccine in Healthy Children 15 m of Age - This study is currently recruiting patients (Current: 23 Nov 2006)
• Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adult Subjects - This study has been completed (Current: 23 Nov 2006)
• Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of Combined Hepatitis A & B Vaccine vs Monovalent Hepatitis A & Hepatitis B Vaccines - This study has been completed (Current: 23 Nov 2006)
• Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Mth Schedule in Healthy Children - This study has been completed (Current: 23 Nov 2006)
• Long-Term Immune Persistence of GSK Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0,6 Mths Schedule in Healthy Adult Subjects - This study has been completed (Current: 23 Nov 2006)
• Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults - This study has been completed (Current: 23 Nov 2006)
• Long-Term Immune Persistence of GSK Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0,12 Mths Schedule in Healthy Adult Volunteers - This study has been completed (Current: 23 Nov 2006)
• Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live Safety Study - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Safety of GlaxoSmithKline (GSK) Biologicals Hepatitis A Vaccine in Korean Population - This study has been completed (Current: 23 Nov 2006)
• A Randomized Trial of Vaccine Adherence in Young Injection Drug Users - 1 - This study is currently recruiting patients (Current: 23 Nov 2006)
• Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age - This study is currently recruiting patients (Current: 23 Nov 2006)
• Phase III, Open, Comparative Study in Healthy Adults Aged 18-50 Years Administered With Hepatyrix or Havrix + Typherix or Tiphim Vi, to Compare Reactogenicity and Immunogenicity. - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients - This study is currently recruiting patients (Current: 23 Nov 2006)
• Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-Infected Patients - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Increasing HAART-Induced Immune Restoration With Cyclosporine - This study is no longer recruiting patients (Current: 23 Nov 2006) - Abacavir sulfate, Lamivudine and Zidovudine,Cyclosporine,Efavirenz
• A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications - This study has been completed (Current: 23 Nov 2006)
• The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV - This study is currently recruiting patients (Current: 23 Nov 2006)
• Twinrix Alternative Schedule Study - This study is no longer recruiting patients (Current: 23 Nov 2006)

Drugs used in Clinical Trials for Hepatitis A

The format for each of the following is:

• The drug,
• followed by the name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.

ClinicalTrials.gov has listed the following drugs in trials for Hepatitis A:

• Abacavir sulfate, Lamivudine and Zidovudine - Increasing HAART-Induced Immune Restoration With Cyclosporine - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Cyclosporine - Increasing HAART-Induced Immune Restoration With Cyclosporine - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Efavirenz - Increasing HAART-Induced Immune Restoration With Cyclosporine - This study is no longer recruiting patients (Current: 23 Nov 2006)

The trial data on this page has been sourced from

• The U.S. National Library of Medicine (NLM) together with ClinicalTrials.gov

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