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

NCT01775137 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-11-06

Study results available
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Summary

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.

Conditions

  • Long-term Safety of TIP

Interventions

DRUG

TBM100

Tobramycin inhalation powder (TIP) 112mg/b.i.d

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT01775137 on ClinicalTrials.gov