KPStudySearch

A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

Overall Recruitment Status: Active, enrollment completed

Official Title

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation

Region

Sponsors

California - Northern

Vertex Pharmaceuticals, Inc.

Acronym

KP IRB No.

1300387

Study Type

Phase

Clinical Trial

Phase III

Study Population Description

Male and female individuals with CF who are 12 years of age or older who are homozygous or heterozygous for the F508del mutation.

Purpose

This study will evaluate the long-term safety and tolerability of VX-445 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

This is a Phase 3, multicenter, open-label study for subjects who completed the last Treatment Period visit in a parent study and meet eligibility criteria. All subjects will receive the TC of VX-445/TEZ/IVA at the same dose level as that evaluated in Study 445-102 and Study 445-103.

Gender

Age Limit

Male & Female

Inclusion Criteria

Subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (ICF), and, when appropriate, an assent form.

Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.

Did not withdraw consent from a parent study.

Meets at least 1 of the following criteria: (1) Completed study drug treatment in a parent study, (2) Had study drug interruption(s) in a parent study, but completed study visits up to the last scheduled visit of the Treatment Period of a parent study.

Willing to remain on a stable CF treatment regimen (as defined in Section 9.5) through completion of study participation.

Exclusion Criteria

History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.

Pregnant and nursing females. Females of childbearing potential must have a negative pregnancy test at the Day 1 Visit before receiving the first dose of study drug.

History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator. (e.g., subjects with a history of allergy or hypersensitivity to the study drug.)

Current participation in an investigational drug trial (other than a parent study). Participation in a noninterventional study (including observational studies, registry studies, and studies requiring blood collections without administration of study drug) and screening for another Vertex study is permitted.

Keywords and/or Specific Medical Conditions

Chloride Channel Agonists	Lung Diseases
Cystic Fibrosis	Membrane Transport Modulators
Digestive System Diseases	Molecular Mechanisms of Pharmacological Action
F508del mutation	Pancreatic Diseases
Fibrosis	Pathologic Processes
Genetic Diseases, Inborn	Respiratory Tract Diseases
Infant, Newborn, Diseases	Pulmonary Disease
Ivacaftor

KP Clinical Facility

Oakland Medical Center

Oakland Medical Center

Clinical Area

Pulmonary Disease

Pulmonary Disease

Principal Investigator:

Bryon Quick, MD

Bryon Quick, MD

Contact Information:

	-	Carolyn Beebe
	-	carolyn.k.beebe@kp.org
	-	Central Valley-Manteca

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