Ext. Long-term Safety Study in CF Patients: Single Arm TIP

Completed · Phase 4

Conditions studied: Long-term Safety of TIP

In brief

The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.

Key facts

Study ID

NCT01775137

Run by

Novartis Pharmaceuticals

People needed

45

Starts

2013-02-01

Expected to finish

2014-11-01

Last updated by the study team

2015-11-06

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study

You may not qualify if…

• Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry into the extension
• Use of loop diuretics within 7 days prior to entry into the extension study
• Pregnant or nursing women
• Women of child bearing potential unless using highly effective method of contraception as indicated in the protoco

Where it is running

• Novartis Investigative Site — Akron, Ohio, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Caba, Buenos Aires, Argentina
• Novartis Investigative Site — Capital Federal, Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — New Lambton Heights, New South Wales, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Florence, FI, Italy
• Novartis Investigative Site — Palermo, Italy, Italy
• Novartis Investigative Site — Messina, ME, Italy
• Novartis Investigative Site — Verona, VR, Italy
• Novartis Investigative Site — Roma, Italy
• Novartis Investigative Site — Mexico City, Mexico City, Mexico
• Novartis Investigative Site — Monterrey, Nuevo León, Mexico
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Valencia, Valencia, Spain

Full record on ClinicalTrials.gov

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