Status:
COMPLETED
Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic Fibrosis
Lead Sponsor:
AO GENERIUM
Conditions:
Cystic Fibrosis
Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Detailed Description
Cystic fibrosis (CF) is a common hereditary disease with an autosomal recessive type of inheritance, characterized by systemic damage to the exocrine glands, mainly the bronchopulmonary and gastrointe...
Eligibility Criteria
Inclusion
- Signed Patient Informed Consent Form for participation in the study;
- Men and women 18 years and older;
- Diagnosis of cystic fibrosis, defined as the presence of disease symptoms and a positive sweat test and / or detection of 2 mutations of the MVTR gene during genotyping;
- FEV1 ≥40% and ≤100% of the proper value;
- The ability to understand the protocol requirements, to give written consent to participate in the study (including the use and transfer of information about the patient's health status related to the study).
Exclusion
- Hypersensitivity to any of used study drug, to their components, as well as a history of significant allergic reactions;
- Acute respiratory infection or exacerbation of chronic pulmonary disease within 4 weeks prior to screening and without corticosteroid or antibiotic therapy;
- Concomitant diseases and conditions with potential impact the patients safety, including:
- Severe renal impairment (serum creatinine more than 1.5 times higher than the upper limit of normal);
- Severe liver impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) blood serum activity is 2.5 times or more higher than the upper limit of the laboratory norm);
- A history of lung transplantation or planned transplantation during this study;
- The presence of antibodies to HIV, active viral hepatitis B and / or C and / or cirrhosis in the history or detected on Screening;
- Pregnancy and lactation;
- Refusal of patients with preserved reproductive potential to use adequate contraception throughout the study and within 30 days after the end of the study;
- Patients who underwent a blood or blood components transfusion within 10 days prior to screening;
- Drug or alcohol abuse at the time of Screening or in the past;
- Patient's participation in any other clinical trials and / or administration of an experimental drug within 30 days prior to the Screening Visit.
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04468100
Start Date
August 30 2017
End Date
May 16 2018
Last Update
July 13 2020
Active Locations (14)
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1
Regional Clinical Hospital
Barnaul, Altayskiy Kray, Russia, 656024
2
Republican Clinical hospital named after G.G. Kuvatov
Ufa, Bashkortostan Republic, Russia, 450005
3
Crimean federal university named after V.I.Vernadsky
Simferopol, Crimea Republic, Russia, 295007
4
Sverdlovsk Regional clinical hospital No. 1
Yekaterinburg, Sverdlovsk Oblast, Russia, 620102