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

NCT01775137 | Completed Phase 4 Results DMC

• 1 other identifier: CTBM100C2401E1
• Study Type: interventional
• Target: 45
• Locations: 9 countries
• Sites: 21

Brief 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

Keywords

CF, Open-label, TIP, phase IV, extension study

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles

  An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe. Death was a fatal event leading to permanent cessations of all vital functions of the body.

  Baseline (start of study treatment in core study) to Day 673 (end of the extension study)

Secondary Outcomes (19)

• Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles

  Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)

• Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles

  Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day

• Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles

  Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)

• Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles

  Baseline of core study, Day 673 (end of the extension study)

• Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles

  Baseline of core study, Day 673 (end of the extension study)

Study Arms (1)

TBM100

EXPERIMENTAL

TIP 112 mg/b.i.d

Drug: TBM100

Interventions

TBM100 DRUG

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

TBM100

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (21)

Novartis Investigative Site

Akron, Ohio, 44308, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29425, United States

Location

Novartis Investigative Site

Dallas, Texas, 75230, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Caba, Buenos Aires, C1425DTG, Argentina

Location

Novartis Investigative Site

Capital Federal, Buenos Aires, C1425EFD, Argentina

Location

Novartis Investigative Site

Córdoba, Córdoba Province, X5014AKN, Argentina

Location

Novartis Investigative Site

New Lambton Heights, New South Wales, 2305, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3052, Australia

Location

Novartis Investigative Site

Montreal, Quebec, H3T1C5, Canada

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Budapest, 1121, Hungary

Location

Novartis Investigative Site

Florence, FI, 50139, Italy

Location

Novartis Investigative Site

Palermo, Italy, 90100, Italy

Location

Novartis Investigative Site

Messina, ME, 98125, Italy

Location

Novartis Investigative Site

Verona, VR, 37126, Italy

Location

Novartis Investigative Site

Roma, 00161, Italy

Location

Novartis Investigative Site

Mexico City, Mexico City, 06720, Mexico

Location

Novartis Investigative Site

Monterrey, Nuevo León, 64020, Mexico

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 24, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 6, 2015
• Results First Posted: November 6, 2015

Record last verified: 2015-11

Locations

ES (2); ME (2); HU (1); IT (5); AU (2); CA (1); US (4); DE (1); AR (3)