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Immunoglobulin Replacement Therapy

Panzyga for Chronic Lymphocytic Leukemia

Phase 3

Recruiting

Research Sponsored by Octapharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age.

Treatment-naïve or relapsed/refractory CLL patients undergoing CLL antineoplastic treatment. Diagnosis of B-cell CLL established according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and documented within medical records.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

This trial is studying how well Panzyga works in preventing primary infection in patients with chronic lymphocytic leukemia.

Who is the study for?

This trial is for adults over 18 with Chronic Lymphocytic Leukemia (CLL) who have low IgG levels and are either untreated or relapsed. They must not have had major infections recently, severe liver or kidney disease, weigh over 140 kg, or be HIV positive. Women of childbearing age must agree to use contraception.Check my eligibility

What is being tested?

The study tests Panzyga's effectiveness in preventing infections in CLL patients compared to a placebo. It's double-blind meaning neither the participants nor the researchers know who gets what treatment until after the results are analyzed.See study design

What are the potential side effects?

Possible side effects include allergic reactions like anaphylaxis, systemic responses to immunoglobulin or blood products, and potential increased risk of blood clots due to hypercoagulable states.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have CLL and am starting or retrying treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of major infections

Secondary outcome measures

Duration of prophylaxis with anti-infectives

Frequency of prophylaxis with anti-infectives

Overall infection rate

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PanzygaExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panzyga

2011

N/A

~350

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

OctapharmaLead Sponsor

84 Previous Clinical Trials

7,618 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still taking in volunteers for this experiment?

"Yes. The trial is currently looking for patients, with the most recent update on 8/10/2022. This study was first posted on 10/5/2020 and is looking to enroll 240 patients from 4 different sites."

Answered by AI

Has Panzyga been cleared by the FDA?

"There is both efficacy and safety data from Phase 3 trials, so our team has given Panzyga a score of 3."

Answered by AI

This study is being hosted in how many different sites?

"At the moment, there are 4 sites running this trial. Patients can select from locations in Baltimore, Saint Petersburg, Rochester and other cities. To limit travel burden, patients should choose the site that is geographically closest to them."

Answered by AI

Are there any precedents for the use of Panzyga in medical research?

"The first clinical trials for Panzyga were completed in 2008 at Montefiore Medical Center. To date, there have been a total of 18439 completed clinical trials worldwide. As of now, 37 different medical studies are ongoing with several taking place in Baltimore, Maryland."

Answered by AI

How many total participants are needed for this research project?

"That is accurate. The information available on clinicaltrials.gov seems to show that the trial is still open for enrollment. This particular study was first advertised on October 5th, 2020 and updated as recently as August 10th, 2022. They are looking for a total of 240 people to participate at 4 different locations."

Answered by AI

What are some of the common reasons why patients receive Panzyga?

"Panzyga has been shown to be an effective form of treatment for bruton's agammaglobulinemia, primary immunodeficiencies (pid), and agammaglobulinemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)

2020. "Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04502030.

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