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

Novartis

Status and phase: Completed; Phase 4

Conditions: Long-term Safety of TIP

Treatments: Drug: TBM100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01775137

CTBM100C2401E1

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

45 participants in 1 patient group

TBM100

Experimental group

Description:

TIP 112 mg/b.i.d

Treatment:

Drug: TBM100