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HepTcell Immunotherapy for Chronic Hepatitis B
Study Summary
This trial will test a new treatment for people with inactive chronic hepatitis B who have low levels of hepatitis B surface antigen. The treatment will be evaluated for its ability to fight the virus, its safety, and its ability to provoke an immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- The given statement is not a screening criterion. It is a direct question asking for the participant's height in inches.I am between 18 and 65 years old.I have had inactive hepatitis B for at least a year.Your liver function tests, including AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome), and direct bilirubin, should be within normal limits at the time of screening.You have high levels of HBV DNA in your blood sample taken during the screening process.The amount of a certain virus in your blood called qHBsAg is too high or too low for you to participate in the study.I weigh... pounds.
- Group 1: HepTcell
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there any governing body that has greenlit HepTcell?
"There is limited data surrounding HepTcell's efficacy, however there are no concerns about safety at this time. As such, it received a score of 2."
Are patients currently being enrolled in this research project?
"That is correct, the clinical trial mentioned is still looking for patients and was last updated on September 7th, 2020. This particular study needs 80 volunteers from 10 hospitals or clinics."
If I wanted to, could I join this research project?
"This clinical trial is looking for 80 patients that fit the following criteria: They must be between 18 and 65 years old, have hepatitis b, and be chronic. In addition, it is important that patients meet the following other requirements: How tall are you in inches?, How much do you weigh in pounds?, Men and women 18 to 65 years of age, inclusive, Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1, qHBsAg ≥ 10 IU/mL but ≤ 100 IU/mL in the 12 months prior to screening, HBV DNA ≥ 10 IU/mL at screening"
How many places are coordinating this clinical trial?
"To limit travel as a barrier to participation, the 10 enrolling sites for this trial are located in major cities including Ottawa, Edmonton and Toronto."
How many people can join this clinical trial at the most?
"This study requires 80 individuals that meet the pre-determined requirements for inclusion. If you are located near The Ottawa Hospital in Ottawa, Ontario or University of Alberta Hospital in Edmonton, Alberta you may be able to participate."
Does this research project accept young people as participants?
"In order to be included in this research project, patients must between 18 and 65 years old. For perspective, there are 30 similar studies for people who are underaged and 247 for senior citizens."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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