Hepatitis B Clinical Trial
Official title:
A Pilot Safety Study to Determine the Presence of Hepatitis B Virus in Downstream Injection Samples Using the HSI-500 Jet Injector With Protector Cap
Verified date | April 2007 |
Source | PATH |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The primary purpose of this study is to determine the ability of the Protector Cap Jet Injector to prevent cross-contamination in the next injection sample. The hypothesis is that the Protector Cap Jet Injector will prevent contamination in the next injection sample, even following injection of volunteers with high levels of hepatitis B virus.
Status | Completed |
Enrollment | 17 |
Est. completion date | January 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Between the age of 18 and 60 years. - Either male or female. - In good health, by self-report and confirmed by physical exam. - Willing and able to follow procedural requirements of the study. - Willing and able to provide informed consent for study participation. - Ability to read and understand informed consent information sheet in English. For Hepatitis B Positive Volunteers - Actively infected with blood levels of greater than or equal to 10*6 hepatits B virus (HBV) copies/mL, confirmed by HBV DNA blood test conducted up to 21 days prior to the day of study enrollment (existing patient record) - Not presently taking any heparin-based drugs that could potentially interfere with HBV assays. For Hepatitis B Negative Volunteers - Not actively infected with HBV as confirmed by HBV tests. - Not presently taking any drugs that could potentially interfere with HBV assays. - No prior history of HBV infection. Exclusion Criteria: - Requires anti-viral HBV therapy. - History of allergic reactions or anaphylaxis to immunizations. - Dermatological conditions affecting the injection site (such as eczema). - Blood coagulation disorders or history of taking drugs that affect blood coagulation. - Presently taking any heparin-based medication (Calciparine, Liquaemin Sodium, Hep-Lock, or Hep-Lock U/P) that could potentially interfere with HBV assays. - History of severe psychiatric disease. - Previous suicidal attempt or hospitalization for psychiatric episode within the last 24 weeks. - Any other conditions or circumstances that, in the opinion of the investigator, may be a threat to the safety and welfare of the volunteer. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
PATH | Bill and Melinda Gates Foundation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of hepatitis B virus in post-injection saline samples as verified by a polymerase chain reaction (PCR)-based assay | |||
Secondary | Evaluation of injection site reactions by observation and self-report of pain on a scale (none, mild, moderate, severe) |
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