Your session is about to expire
← Back to Search
Study Summary
This trial is testing a new way to give immunoglobulin to people with primary immunodeficiency diseases, to see if it is effective and safe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- My IgG levels have been above 5 g/L recently and at screening.I have a condition like leukemia or lymphoma that weakens my immune system.My liver is not working well (ALT levels are very high).You have a history of alcohol, drug, or substance abuse within the past year.I have a confirmed PID diagnosis and need immunoglobulin therapy.I have a specific type of immune deficiency.I've been on a stable dose of IVIG, SCIG, or fSCIG for 12 weeks.I have had a blood clot or related condition in the past year or twice in my life.I have kidney problems or a high risk of kidney failure.My diabetes is not under control (HbA1c > 7%).My blood pressure is not controlled and is above the recommended level for my age.I haven't taken immunosuppressants or chemotherapy in the last year.I haven't had any live vaccines in the last month or plan to during the study.I haven't needed IV antibiotics for infections or had a serious bacterial infection in the last 3 months.I haven't taken high doses of steroids by mouth or injection recently.I am on blood thinners that make certain injections risky.I haven't received any blood products except IgG for PID in the last 3 months.I have an abnormal heart rate that is either too fast or too slow with symptoms.I am between 2 and 75 years old.You have had an allergic reaction to IgA in other products before.I have a condition causing significant protein loss in my urine.I am a man and agree to use birth control during the study.You have a history of severe allergic reactions or ongoing allergies to certain substances, including Newnorm and its components like glycine.
- Group 1: Newnorm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
In how many different medical clinics is this clinical trial being performed today?
"To make it more convenient for potential enrollees, this clinical trial is running at 8 sites across the country. If you are interested in participating, please choose the location nearest to you from amongst these options: Irvine, Chicago, Omaha or one of the other 5 locations."
Does this experiment test subjects who are over the age of 40?
"According to the inclusion criteria for this study, patients between the ages of 2 and 75 are eligible. However, there 60 trials specifically designed for children and 47 trials geared towards elderly patients."
Are there any limitations to the number of people who can take part in this research?
"That is correct. The information available on clinicaltrials.gov confirms that this study, which was first posted on 8/4/2021, is still recruiting patients. Currently, the trial needs to enroll 50 patients from 8 different medical centres."
What goals does this medical study hope to achieve?
"The principle aim of this 16 week study, as set by the sponsor Octapharma, is to measure the Rate of Serious Bacterial Infections. Additionally, researchers will be looking at other health metrics like the SF-36 Health Survey for patients aged 14 and up, Hospitalisations due to infection (number of days and annual rate), and finally Days lost from work or school because of infection."
What are the potential negative consequences of taking Newnorm?
"Newnorm has been evaluated as a level 3 safety risk because it is in Phase 3 clinical trials. This means that while there is some data supporting its efficacy, there are also multiple rounds of data supporting its safety."
Could I be a candidate for this experiment?
"Individuals that meet the following criteria may be accepted into this clinical trial: a primary antibody deficiency and an age between 2 and 75. Up to 50 patients will be enrolled in total."
Can new patients still join the research study?
"If you're reading this, it's likely that you qualify for this study. To be clear, the research team is still accepting applications and the deadline is November 4th, 2022."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger