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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)

NCT04502030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2025-10-03

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

Panzyga

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

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2025-09-19
Completion
2025-09-19
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Poland
  • Russia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04502030 on ClinicalTrials.gov