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Report for Clinical Trial NCT03061331

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.

NCT03061331 Cystic Fibrosis
MeSH:Cystic Fibrosis Fibrosis

2 Interventions

Name: LUM/IVA

Description: LUM 400 mg/IVA 250 mg every 12 hours (q12h)
Type: Drug
Group Labels: 2

Treatment Sequence 1 Treatment Sequence 2

Name: Placebo

Description: No Active Drug
Type: Drug
Group Labels: 2

Treatment Sequence 1 Treatment Sequence 2


Primary Outcomes

Description: FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.

Measure: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 8

Time: Study Baseline, Through Week 8

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There are 11 SNPs

SNPs


1 A455E

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation. --- A455E ---

Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation. --- A455E ---

Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation. --- A455E --- --- A455E ---

Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 8. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.. Inclusion Criteria: - Male or female with confirmed diagnosis of CF - All subjects must have an A455E mutation on at least 1 CFTR allele; no more than 10 subjects may have an F508del mutation on 1 CFTR allele. --- A455E ---

- Use of strong inhibitors or strong inducers of CYP3A, including consumption of certain herbal medications and certain fruit and fruit juices, within 14 days before Day 1 - Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements Inclusion Criteria: - Male or female with confirmed diagnosis of CF - All subjects must have an A455E mutation on at least 1 CFTR allele; no more than 10 subjects may have an F508del mutation on 1 CFTR allele. --- A455E ---


2 G1244E

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D --- --- G1244E ---


3 G1349D

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D --- --- G1244E --- --- G1349D ---


4 G178R

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D --- --- G1244E --- --- G1349D --- --- G178R ---


5 G551D

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D ---


6 G551S

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S ---


7 R117H

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N --- --- S549R --- --- R117H ---


8 S1251N

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N ---


9 S1255P

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P ---


10 S549N

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N ---


11 S549R

- A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele. --- G551D --- --- G1244E --- --- G1349D --- --- G178R --- --- G551S --- --- S1251N --- --- S1255P --- --- S549N --- --- S549R ---



HPO Nodes