Is NCT07220915 recruiting in Glendale, AZ?

Yes, NCT07220915 is currently recruiting participants at its Glendale, AZ location. This hypogammaglobulinemia clinical trial is actively enrolling qualified participants.

How do I join the hypogammaglobulinemia clinical trial in Glendale?

To join this clinical trial in Glendale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Glendale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Hypogammaglobulinemia Clinical Trial in Glendale, AZ

About This Hypogammaglobulinemia Study in Glendale

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy

Sponsor: Octapharma

Who Can Participate

Inclusion Criteria

Patients who meet all of the following criteria will be eligible to participate in the study:

Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis/myositis, SLE, SS, IIM, MCTD, UCTD, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder). Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.

Have hypogammaglobulinemia (IgG levels \<5 g/L as confirmed by the central laboratory).

Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..

Are willing and able to comply with a highly effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from participation in the study:

Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component

Have a current major infection at Screening or had \>1 major infection within 6 months prior to Baseline

Have a history of thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline

Have a known IgA deficiency with antibodies to IgA

Have a known blood hyperviscosity or other hypercoagulable states

Have been diagnosed with primary immunodeficiency.

Have a severe liver disease, with signs of ascites or hepatic encephalopathy

Have a severe kidney disease (as defined by eGFR \<30 mL/min/1.73 m2)

Have a body weight \>140 kg

HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV- 1/2 antigen/antibody immunoassay followed by positive HIV-1/HIV-2 antibody differentiation immunoassay)

Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV titers, who will not receive targeted antiviral therapy while participating in the study, and patients with active HBV, defined as high HBV titers.

Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).

Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study

Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration

Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product within 3 months prior to Baseline or during the course of this study. Participation in observational or open-label studies involving an approved product may be permitted after consultation with the Medical Monitor.

If female, are pregnant or lactating

Are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Glendale?

Yes, this clinical trial (NCT07220915) has an active research site in Glendale, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Hypogammaglobulinemia Treatment Options in Glendale, AZ

If you're searching for hypogammaglobulinemia treatment options in Glendale, AZ, this clinical trial (NCT07220915) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Glendale research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced hypogammaglobulinemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hypogammaglobulinemia clinical trials near you to find additional studies recruiting in your area.

Hypogammaglobulinemia Clinical Trial in Glendale, AZ

Expert Care in Glendale

IRB Approved

No-Cost Care

Apply for This Glendale Location

Why Participate?

Simple Process