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Report for Clinical Trial NCT03068312

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older and Have Either a 3849 + 10KB C→T or D1152H-CFTR Mutation

This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.

NCT03068312 Cystic Fibrosis
MeSH: Cystic Fibrosis Fibrosis

2 Interventions

Name: Ivacaftor

Description: IVA 150 mg tablet.

Type: Drug

Sequence 1: First Ivacaftor (IVA) Then Placebo Sequence 2: First Placebo Then IVA

Name: Placebo

Description: Placebo matched to IVA tablet.

Type: Drug

Sequence 1: First Ivacaftor (IVA) Then Placebo Sequence 2: First Placebo Then IVA


Primary Outcomes

Description: LCI2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.

Measure: Change in Lung Clearance Index 2.5 (LCI2.5)

Time: From baseline through 8 weeks

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There are 11 SNPs

SNPs


1 D1152H

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older and Have Either a 3849 + 10KB C→T or D1152H-CFTR Mutation. --- D1152H ---

A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation. --- D1152H ---

A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation. --- D1152H --- --- D1152H ---

- A 3849 + 10KB C→T or D1152H mutation on at least 1 CFTR allele. --- D1152H ---


2 G1244E

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E ---


3 G1349D

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D ---


4 G178R

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R ---


5 G551D

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D ---


6 G551S

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S ---


7 R117H

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N --- --- S549R --- --- R117H ---


8 S1251N

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N ---


9 S1255P

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P ---


10 S549N

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N ---


11 S549R

Exclusion Criteria: - A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N --- --- S549R ---



HPO Nodes