Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT04502030

PHASE3

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)

Sponsor: Octapharma

View on ClinicalTrials.gov

Summary

Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

247

Start Date

2020-10-05

Completion Date

2025-09-19

Last Updated

2026-06-04

Healthy Volunteers

Conditions

Chronic Lymphocytic Leukemia Hypogammaglobulinemia

Interventions

BIOLOGICAL

Panzyga

Panzyga is a 10% IVIG produced from a pool of human fresh frozen plasma donations

OTHER

Placebo

Inclusion Criteria: 1. 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. 2. Hypogammaglobulinemia (IgG levels \<5 g/L) as confirmed by the Central Laboratory. 3. ≥18 years of age. 4. Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted. Exclusion Criteria: 1. IgG treatment within 3 months prior to Screening. 2. Antibiotic prophylaxis and/or treatment within 7 days prior to Baseline (with the exception of trimethoprim-sulfamethoxazole \[TMP/SMX\], diaminodiphenyl sulfone \[dapsone\] and pentamidine inhalation). 3. Current major infection or \>1 major infection in the previous 6 months before Baseline. 4. History of anaphylaxis or severe systemic response to immunoglobulin, blood or plasma-derived products or any Panzyga component. 5. History of a non-CLL malignancy or other medical condition with life-expectancy of less than two years. 6. Severe liver disease, with signs of ascites and/or hepatic encephalopathy. 7. Severe kidney disease (as defined by estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m2). 8. Body weight \>140 kg. 9. Eastern Cooperative Oncology Group (ECOG) performance score of \>2 (Appendix 1). 10. Female patients of childbearing potential unwilling to use a protocol-required method of contraception (as per protocol section 7.3.9 b) from the Screening Visit throughout the study treatment period and for 30 days following the last dose of study drug. 11. Human immunodeficiency virus (HIV) infection at Screening (defined for the study as positive HIV antibody test). 12. 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 undergoing CLL therapy, and patients with active HBV, defined as high HBV titers. 13. Uncontrolled hepatitis C infection at Screening (defined for the study as positive hepatitis virus C \[HCV\] polymerase chain reaction \[PCR\]). 14. Pregnant and lactating women. 15. Subjects with a history of thromboembolic events (TEE) such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV) within 6 months before Baseline. 16. Planned or ongoing immunosuppressive treatment (other than for CLL or corticosteroids) or other forbidden medication during the entire study duration after study enrollment. 17. Participation in another interventional clinical trial that is either blinded or involves an investigational (not approved) product within 3 months before Baseline or during the course of the clinical study. Participation in observational clinical trials or open-label trials involving an approved product may be permitted after consultation with the medical monitor. 18. Known IgA deficiency with antibodies to IgA. 19. Known blood hyperviscosity, or other hypercoagulable states. 20. Patients unable or unwilling to understand or comply with the study protocol.

Locations (84)

Octapharma Research Site

St. Petersburg, Florida, United States

Octapharma Research Site

Columbus, Georgia, United States

Octapharma Research Site

Macon, Georgia, United States

Octapharma Research Site

New Orleans, Louisiana, United States

Octapharma Research Site

Baltimore, Maryland, United States

Octapharma Research Site

Baltimore, Maryland, United States

Octapharma Research Site

Detroit, Michigan, United States

Octapharma Research Site

Rochester, Minnesota, United States

Octapharma Research Site

Buffalo, New York, United States

Octapharma Research Site

New York, New York, United States

Octapharma Research Site

New York, New York, United States

Octapharma Research Site

Shirley, New York, United States

Octapharma Research Site

Durham, North Carolina, United States

Octapharma Research Site

Charleston, South Carolina, United States

Octapharma Research Site

Houston, Texas, United States

Octapharma Research Site

Brno, Czechia

Octapharma Research Site

Hradec Králové, Czechia

Octapharma Research Site

Ostrava, Czechia

Octapharma Research Site

Aalborg, Denmark

Octapharma Research Site

Herning, Denmark

Octapharma Research Site

Roskilde, Denmark

Octapharma Research Site

Dortmund, Germany

Octapharma Research Site

Frankfurt, Germany

Octapharma Research Site

Kiel, Germany

Octapharma Research Site

Marburg, Germany

Octapharma Research Site

Athens, Greece

Octapharma Research Site

Athens, Greece

Octapharma Research Site

Athens, Greece

Octapharma Research Site

Ioannina, Greece

Octapharma Research Site

Pátrai, Greece

Octapharma Research Site

Thessaloniki, Greece

Octapharma Research Site

Budapest, Hungary

Octapharma Research Site

Debrecen, Hungary

Octapharma Research Site

Győr, Hungary

Octapharma Research Site

Kaposvár, Hungary

Octapharma Research Site

Nyíregyháza, Hungary

Octapharma Research Site

Haifa, Israel

Octapharma Research Site

Haifa, Israel

Octapharma Research Site

Petah Tikva, Israel

Octapharma Research Site

Castelfranco Veneto, Italy

Octapharma Research Site

Milan, Italy

Octapharma Research Site

Milan, Italy

Octapharma Research Site

Modena, Italy

Octapharma Research Site

Orbassano, Italy

Octapharma Research Site

Padova, Italy

Octapharma Research Site

Pescara, Italy

Octapharma Research Site

Reggio Calabria, Italy

Octapharma Research Site

Rome, Italy

Octapharma Research Site

Torino, Italy

Octapharma Research Site

Bialystok, Poland

Octapharma Research Site

Bydgoszcz, Poland

Octapharma Research Site

Gdansk, Poland

Octapharma Research Site

Gdansk, Poland

Octapharma Research Site

Gdynia, Poland

Octapharma Research Site

Katowice, Poland

Octapharma Research Site

Legnica, Poland

Octapharma Research Site

Lodz, Poland

Octapharma Research Site

Torun, Poland

Octapharma Research Site

Warsaw, Poland

Octapharma Research Site

Wroclaw, Poland

Octapharma Research Site

Barnaul, Russia

Octapharma Research Site

Kemerovo, Russia

Octapharma Research Site

Moscow, Russia

Octapharma Research Site

Moscow, Russia

Octapharma Research Site

Nizhny Novgorod, Russia

Octapharma Research Site

Novosibirsk, Russia

Octapharma Research Site

Petrozavodsk, Russia

Octapharma Research Site

Rostov-on-Don, Russia

Octapharma Research Site

Saint Petersburg, Russia

Octapharma Research Site

Samara, Russia

Octapharma Research Site

Tomsk, Russia

Octapharma Research Site

Tula, Russia

Octapharma Research Site

Ufa, Russia

Octapharma Research Site

Yekaterinburg, Russia

Octapharma Research Site

Madrid, Spain

Octapharma Research Site

Madrid, Spain

Octapharma Research Site

Madrid, Spain

Octapharma Research Site

Oviedo, Spain

Octapharma Research Site

Santander, Spain

Octapharma Research Site

Ankara, Turkey (Türkiye)

Octapharma Research Site

Antalya, Turkey (Türkiye)

Octapharma Research Site

Istanbul, Turkey (Türkiye)

Octapharma Research Site

Izmir, Turkey (Türkiye)

Octapharma Research Site

Kayseri, Turkey (Türkiye)

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (84)