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Drug & research development » Clinical trials » NCT01381289

VX-770 Expanded Access Program

Official title: VX-770 Expanded Access Program (EAP)

Clinical Trials gov number: NCT01381289

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Purpose: To provide ivacaftor prior to its commercial availability to CF patients who have at least one copy of the G551D-CFTR mutation and who are in critical medical need and who are not eligible for participation in other Vertex-sponsored studies.

Phase: NA

Type: Expanded access

Study sponsor: Vertex Pharmaceuticals Incorporated

  • Male or female with confirmed diagnosis of CF, with a sweat chloride >60 mmol/L OR 2 CF-causing mutations AND chronic sinopulmonary disease OR gastrointestinal/nutritional abnormalities
  • Have the G551D-CFTR mutation in at least 1 allele
  • Aged 6 years or older on the date of signed informed consent form
  • Highest FEV1 in the 6 months prior to screening is ≤ 40% predicted value or patient is documented to be active on the lung transplant wait list

Intervention
Ivacaftor

Geographical Location
No contacts or locations provided

Number of Participants
≥1 (≥6 years)

Primary Endpoint

Not provided

Secondary Endpoint

Not provided

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Not provided

View Trial Results