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Drug & research development » Clinical trials » NCT01707290

Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation (KONTNUE)

Official title: A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long Term Ivacaftor Treatment in Subjects 6 Years of Age and Older With Cystic Fibrosis and a Non-G551D CFTR Mutation

Clinical Trials gov number: NCT01707290

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Purpose: To evaluate the safety of long-term ivacaftor treatment in CF patients from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).

Phase: 3

Type: Interventional, non-randomized, open-label, parallel assignment

Study sponsor: Vertex Pharmaceuticals Incorporated; Cystic Fibrosis Foundation Therapeutics

  • Subjects from Study 110 or Study 111 entering the ivacaftor arm must have completed the assigned study drug treatment duration in the previous study
  • Subjects from Study 113 entering the ivacaftor arm must have completed all study related treatments through the follow-up visit and met the Study 113 responder criteria during the previous study
  • Subjects entering the observational arm must have completed ≥4 weeks of study drug treatment in their previous study (Study 110 or Study 111), must have completed the previous study but do not wish to enrol in the ivacaftor arm, or must have completed the previous study but do not meet the inclusion criteria of the ivacaftor arm
  • Females of childbearing potential entering the ivacaftor arm must not be pregnant
  • Subjects entering the ivacaftor arm must be willing to comply with contraception requirements

Intervention
Ivacaftor

Geographical Location
Belgium, France, United Kingdom, United States

Number of Participants
101-1000 (≥6 years)

Primary Endpoint

Safety up to 104 weeks

Secondary Endpoint

At 104 weeks

  • Absolute change from baseline (BL) in percent predicted forced expiratory volume in 1 second (FEV1)
  • Change from BL in body mass index

– Change from BL in sweat chloride

  • Change from BL in the respiratory domain of the Cystic Fibrosis Questionnaire Revised
  • Pulmonary exacerbation

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  • Experimental:

Ivacaftor 150 mg, oral use, every 12 hours (q12h)

Subjects in the ivacaftor arm, who have not taken inhaled hypertonic Saline (HS) for at least 4 weeks, are clinically stable and are exacerbation free will have the option to participate in the optional inhaled HS substudy

  • Observational

No Intervention, Day 1 assessments and long-term follow-up

No results available

View Trial Results