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Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases

Sponsored by Octapharma

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Active, Not Recruiting

Auto-verified from ClinicalTrials.gov

Verified Oct 3, 2025

Phase

Clinical Trial

Sponsor

Octapharma

Enrollment Target

50

Start Date

Aug 2021

๐Ÿ“Š
1 of 50 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases

Who Can Participate

Inclusion Criteria

Age of โ‰ฅ2 years and โ‰ค75 years 2. Documented and confirmed diagnosis of PID as defined by European Society of Immunodeficiencies (ESID) and the Pan American Group for Immune Deficiency (PAGID) and requiring immunoglobulin replacement therapy due to hypogammaglobulinaemia or agammaglobulinaemia. The exact type of PID must be recorded. 3. At least 12 weeks of regular treatment before the screening visit (i.e., with a stable dosing interval) with any IVIG, SCIG, or fSCIG, with a stable IgG dose between 200 and 800 mg/kg/month. A stable dose is defined as one that deviates less than ยฑ25% from the mean dose for all infusions within this 12-week period before screening. 4. Trough level of IgG โ‰ฅ5 g/L at screening and documentation of an IgG trough level of โ‰ฅ5 g/L at least once within the previous 12 weeks. 5. Freely given written informed consent from adult patients or freely given written informed consent from the patient's parent(s)/legal guardian(s) and written infor

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

50 participants

๐ŸŽ‚

Age Range

2 Years - 75 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Octapharma

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Irvine

California

Location available
View Irvine location page
Unknown

Centennial

Colorado

Location available
View Centennial location page
Unknown

Hollywood

Florida

Location available
View Hollywood location page
Unknown

Port Saint Lucie

Florida

Location available
View Port Saint Lucie location page
Unknown

St. Petersburg

Florida

Location available
View St. Petersburg location page
Unknown

Chicago

Illinois

Location available
View Chicago location page
Unknown

Overland Park

Kansas

Location available
View Overland Park location page
Unknown

Louisville

Kentucky

Location available
View Louisville location page
Unknown

White Marsh

Maryland

Location available
View White Marsh location page

๐Ÿ“ And 2 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

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Looking for Primary Immunodeficiency Diseases Treatment in Irvine?

Join others in California exploring innovative treatment options through clinical research

Primary Immunodeficiency Diseases Treatment Options in Irvine, California

If you're searching for Primary Immunodeficiency Diseases treatment in Irvine, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Irvine, Centennial, Hollywood and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Primary Immunodeficiency Diseases. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 50 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Primary Immunodeficiency Diseases?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Primary Immunodeficiency Diseases

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Primary Immunodeficiency Diseases Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04640142. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.