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Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic Fibrosis

NCT04468100 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-07-13

No results posted yet for this study

Summary

It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Tigerase® compared Pulmozyme® in patients with Cystic Fibrosis

Conditions

Interventions

BIOLOGICAL

Tigerase®

2.5 mL (2.5 mg) dornase alfa nebulized once daily for 168 (+/-7) days

BIOLOGICAL

Pulmozyme®

2.5 mL (2.5 mg) dornase alfa nebulized once daily for 168 (+/-7) days

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD · AO GENERIUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-30
Primary Completion
2018-05-16
Completion
2018-05-16

Countries

  • Russia

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 NCT04468100 on ClinicalTrials.gov