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A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03447262
Recruitment Status : Active, not recruiting
First Posted : February 27, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Tracking Information
First Submitted Date  ICMJE February 21, 2018
First Posted Date  ICMJE February 27, 2018
Last Update Posted Date March 8, 2019
Actual Study Start Date  ICMJE July 13, 2018
Estimated Primary Completion Date April 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
Safety and tolerability of long-term treatment with VX-659 in TC with TEZ and IVA based on adverse events (AEs) [ Time Frame: from baseline through safety follow-up (up to 100 weeks) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03447262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Absolute change from baseline in ppFEV1 [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  • Absolute change in sweat chloride (SwCl) [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  • Number of pulmonary exacerbations (PEx) [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  • Time to first PEx [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  • Absolute change in body mass index (BMI) [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  • Absolute change in BMI z-score [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  • Absolute change in body weight [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
  • Absolute change from baseline in CFQ-R respiratory domain score [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
Official Title  ICMJE A Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Brief Summary This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • Drug: VX-659
    Fixed-dose combination (FDC) tablets (VX-659/TEZ/IVA)
  • Drug: TEZ
    FDC tablets (VX-659/TEZ/IVA)
    Other Name: tezacaftor; VX-661
  • Drug: IVA
    FDC tablets (VX-659/TEZ/IVA)
    Other Name: ivacaftor; VX-770
  • Drug: IVA
    IVA tablet
    Other Name: ivacaftor
Study Arms  ICMJE Experimental: Open-label triple combination

Subjects will receive 240 mg VX-659 / 100 mg TEZ / 150 mg IVA as FDC tablets in the morning and 150 mg IVA as mono tablet in the evening.

Parent studies are Phase 3 Vertex studies investigating VX-659 in combination with TEZ and IVA. This includes Studies VX17-659-102 and VX17-659-103.

Interventions:
  • Drug: VX-659
  • Drug: TEZ
  • Drug: IVA
  • Drug: IVA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 6, 2019)
484
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2018)
360
Estimated Study Completion Date  ICMJE April 24, 2021
Estimated Primary Completion Date April 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completed study drug treatment in a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.

Exclusion Criteria:

  • History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
  • Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Denmark,   Germany,   Ireland,   Israel,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03447262
Other Study ID Numbers  ICMJE VX17-659-105
2017-004134-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vertex Pharmaceuticals Incorporated
Study Sponsor  ICMJE Vertex Pharmaceuticals Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vertex Pharmaceuticals Incorporated
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP