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- | faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Journal: Resistance Analyses of HCV NS3/4A Protease and NS5B Polymerase from Clinical Studies of Deleobuvir and Faldaprevir. (Pubmed Central) - Aug 5, 2017
Faldaprevir and deleobuvir RAVs are more prevalent among virologic failures than at baseline. Treatment response was not compromised by common NS3 polymorphisms; however, alanine at NS5B amino acid 499 at baseline (wild-type in GT-1a, polymorphism in GT-1b) may reduce response to this deleobuvir-based regimen.
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial termination: Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients (clinicaltrials.gov) - Apr 11, 2016
P1, N=4, Terminated, Sponsor: Boehringer Ingelheim
Treatment response was not compromised by common NS3 polymorphisms; however, alanine at NS5B amino acid 499 at baseline (wild-type in GT-1a, polymorphism in GT-1b) may reduce response to this deleobuvir-based regimen. Completed --> Terminated
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial termination: Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel (clinicaltrials.gov) - Apr 11, 2016
P1, N=18, Terminated, Sponsor: Boehringer Ingelheim
Completed --> Terminated Completed --> Terminated
- |||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial primary completion date, Combination therapy: Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 (clinicaltrials.gov) - Feb 12, 2016
P3, N=496, Completed, Sponsor: Boehringer Ingelheim
Completed --> Terminated Trial primary completion date: Jan 2015 --> Feb 2014
- ||||||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Trial primary completion date, Combination therapy: IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1 (clinicaltrials.gov) - Feb 23, 2015
P3, N=470, Completed, Sponsor: Boehringer Ingelheim
Trial primary completion date: Jan 2015 --> Feb 2014 Active, not recruiting --> Completed | Trial primary completion date: Feb 2014 --> Jan 2015
- ||||||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Trial primary completion date, Combination therapy: Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 (clinicaltrials.gov) - Feb 23, 2015
P3, N=496, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed | Trial primary completion date: Feb 2014 --> Jan 2015 Active, not recruiting --> Completed | Trial primary completion date: Feb 2014 --> Jan 2015
- | Asclevir (ravidasvir) / Presidio Pharma, Ascletis, Pharco Pharmaceuticals
Trial completion, Combination therapy: Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C (clinicaltrials.gov) - Jan 22, 2015
P2, N=38, Completed, Sponsor: Presidio Pharmaceuticals, Inc.
Active, not recruiting --> Completed | Trial primary completion date: Feb 2014 --> Jan 2015 Active, not recruiting --> Completed
- || deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment change, Combination therapy: 4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients (clinicaltrials.gov) - Nov 24, 2014
P1, N=75, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed N=57 --> 75
- |||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Combination therapy: Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (clinicaltrials.gov) - Nov 18, 2014
P2, N=489, Completed, Sponsor: Boehringer Ingelheim
N=57 --> 75 Active, not recruiting --> Completed
- ||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Trial primary completion date, Combination therapy: Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients (clinicaltrials.gov) - Nov 6, 2014
P1, N=72, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Dec 2013 --> Oct 2014
- | faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Combination therapy: BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3 (clinicaltrials.gov) - Oct 31, 2014
P2b, N=35, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed | Trial primary completion date: Dec 2013 --> Oct 2014 Active, not recruiting --> Completed
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Phase classification, Combination therapy: BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3 (clinicaltrials.gov) - Jul 12, 2014
P2b, N=35, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Phase classification: P3 --> P2b
- ||| deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Single Rising Oral Doses of BI 207127 NA as Powder in the Bottle in Healthy Male Subjects (clinicaltrials.gov) - Jul 8, 2014
P1, N=82, Completed, Sponsor: Boehringer Ingelheim
- | deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Relative Bioavailability of BI 207127 Trial Formulation II Prototypes Versus BI 207127 Trial Formulation I in Healthy Volunteers (clinicaltrials.gov) - Jul 8, 2014
P1, N=42, Completed, Sponsor: Boehringer Ingelheim
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA in Healthy Male Volunteers (clinicaltrials.gov) - Jul 8, 2014
P1, N=37, Terminated, Sponsor: Boehringer Ingelheim
- ||| deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial, Monotherapy: Multiple Oral Doses of BI 207127 NA in Treatment na (clinicaltrials.gov) - Jun 27, 2014
P1, N=75, Completed, Sponsor: Boehringer Ingelheim
- ||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion date, Combination therapy: IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1 (clinicaltrials.gov) - May 27, 2014
P3, N=475, Active, not recruiting, Sponsor: Boehringer Ingelheim
Phase classification: P3 --> P2b Trial completion date: Oct 2015 --> Oct 2014
- ||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion date, Combination therapy: Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 (clinicaltrials.gov) - Apr 29, 2014
P3, N=498, Active, not recruiting, Sponsor: Boehringer Ingelheim
Trial completion date: Oct 2015 --> Oct 2014 Trial completion date: Sep 2015 --> Dec 2014
- || faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment change, Combination therapy: Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients (clinicaltrials.gov) - Mar 18, 2014
P1, N=72, Active, not recruiting, Sponsor: Boehringer Ingelheim
Trial completion date: Sep 2015 --> Dec 2014 N=102 --> 72
- | faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment closed, Combination therapy: BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3 (clinicaltrials.gov) - Mar 4, 2014
P3, N=35, Active, not recruiting, Sponsor: Boehringer Ingelheim
N=102 --> 72 Recruiting --> Active, not recruiting
- | Asclevir (ravidasvir) / Presidio Pharma, Ascletis, Pharco Pharmaceuticals
Enrollment closed, Combination therapy: Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C (clinicaltrials.gov) - Jan 29, 2014
P2, N=36, Active, not recruiting, Sponsor: Presidio Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment closed, Combination therapy: Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients (clinicaltrials.gov) - Jan 23, 2014
P1, N=72, Active, not recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial withdrawal, Combination therapy: Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients (clinicaltrials.gov) - Jan 21, 2014
P3, N=0, Withdrawn, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Recruiting --> Withdrawn
- deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment change: Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects (clinicaltrials.gov) - Jan 21, 2014
P1, N=16, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
Recruiting --> Withdrawn N=32 --> 16
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment change: Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects. (clinicaltrials.gov) - Jan 21, 2014
P1, N=48, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
N=32 --> 16 N=60 --> 48
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment change, Combination therapy: Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients (clinicaltrials.gov) - Jan 21, 2014
P3, N=0, Withdrawn, Sponsor: Boehringer Ingelheim
N=60 --> 48 N=270 --> 0
- ||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment closed, Review, Combination therapy: Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (clinicaltrials.gov) - Jan 21, 2014
P2, N=490, Active, not recruiting, Sponsor: Boehringer Ingelheim
N=270 --> 0 Recruiting --> Active, not recruiting
- deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion: Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects (clinicaltrials.gov) - Jan 21, 2014
P1, N=16, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
Recruiting --> Active, not recruiting Recruiting --> Completed
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion: Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects. (clinicaltrials.gov) - Jan 21, 2014
P1, N=48, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
Recruiting --> Completed Active, not recruiting --> Completed
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion: Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel (clinicaltrials.gov) - Jan 21, 2014
P1, N=18, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion: Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients (clinicaltrials.gov) - Jan 13, 2014
P1, N=4, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Recruiting --> Completed
- deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects (clinicaltrials.gov) - Nov 12, 2013
P1, N=16, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects. (clinicaltrials.gov) - Oct 16, 2013
P1, N=48, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients (clinicaltrials.gov) - Oct 6, 2013
P1, N=4, Completed, Sponsor: Boehringer Ingelheim
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel (clinicaltrials.gov) - Sep 11, 2013
P1, N=18, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion, Combination therapy: This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C (clinicaltrials.gov) - Aug 28, 2013
P2, N=25, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
Recruiting --> Completed Active, not recruiting --> Completed
- ||||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment closed, Combination therapy: IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1 (clinicaltrials.gov) - Aug 6, 2013
P3, N=475, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment closed, Combination therapy: Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 (clinicaltrials.gov) - Jun 12, 2013
P3, N=498, Active, not recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | Asclevir (ravidasvir) / Presidio Pharma, Ascletis, Pharco Pharmaceuticals
New P2 trial, Combination therapy: Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C (clinicaltrials.gov) - May 20, 2013
P2, N=36, Active, not recruiting, Sponsor: Presidio Pharmaceuticals, Inc.
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P3 trial, Combination therapy: Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients (clinicaltrials.gov) - May 19, 2013
P3, N=0, Withdrawn, Sponsor: Boehringer Ingelheim
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion: Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects (clinicaltrials.gov) - Apr 16, 2013
P1, N=32, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P3 trial, Combination therapy: BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3 (clinicaltrials.gov) - Apr 10, 2013
P3, N=35, Active, not recruiting, Sponsor: Boehringer Ingelheim
- faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects (clinicaltrials.gov) - Nov 28, 2012
P1, N=32, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
- |||||||||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P3 trial, Combination therapy: IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1 (clinicaltrials.gov) - Nov 22, 2012
P3, N=475, Active, not recruiting, Sponsor: Boehringer Ingelheim
- |||||||||| faldaprevir (BI201335) / Boehringer Ingelheim, deleobuvir (BI 207127) / Boehringer Ingelheim
New P3 trial, Combination therapy: Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 (clinicaltrials.gov) - Nov 15, 2012
P3, N=498, Active, not recruiting, Sponsor: Boehringer Ingelheim
- deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion: Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers (clinicaltrials.gov) - Jun 26, 2012
P1, N=12, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Completed
- deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers (clinicaltrials.gov) - May 23, 2012
P1, N=12, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
- deleobuvir (BI 207127) / Boehringer Ingelheim
Trial completion: Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers (clinicaltrials.gov) - Apr 3, 2012
P1, N=18, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Completed
- deleobuvir (BI 207127) / Boehringer Ingelheim
Enrollment change: Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers (clinicaltrials.gov) - Mar 6, 2012
P1, N=18, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals
Recruiting --> Completed N=36 --> 18
- deleobuvir (BI 207127) / Boehringer Ingelheim
New P1 trial: Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers (clinicaltrials.gov) - Feb 16, 2012
P1, N=18, Completed, Sponsor: Boehringer Ingelheim Pharmaceuticals