BI 201335

DRUG14 trials

Conditions

HIV InfectionsHepatitis CHepatitis C, ChronicLiver Cirrhosis

Phase 1

Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

CompletedNCT01374802

Boehringer IngelheimHIV Infections

Start: 2011-06-30Updated: 2015-07-31

Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients

CompletedNCT01525628

Boehringer IngelheimHepatitis C, Chronic

Start: 2012-04-30End: 2014-10-31Updated: 2016-06-10

Drug-drug Interaction of BI 201335 and Microgynon

CompletedNCT01570244

Boehringer IngelheimHepatitis C, Chronic

Start: 2012-04-30End: 2012-08-31Updated: 2015-08-03

Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment

CompletedNCT01580306

Boehringer IngelheimHepatitis C

Start: 2012-04-30End: 2012-06-30Updated: 2015-07-31

Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone

CompletedNCT01637922

Boehringer IngelheimHepatitis C

Start: 2012-08-31End: 2012-11-30Updated: 2015-08-03

Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis

CompletedNCT01909778

Boehringer IngelheimHepatitis C, Liver Cirrhosis

Start: 2008-06-30End: 2008-10-31Updated: 2015-08-10

Phase 2

Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

CompletedNCT00984620

Boehringer IngelheimHepatitis C

Start: 2009-09-30Updated: 2015-09-07

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

CompletedNCT01132313

Boehringer IngelheimHepatitis C, Chronic

Start: 2010-05-31End: 2014-10-31Updated: 2016-02-01

Phase 3

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

CompletedNCT01330316

Boehringer IngelheimHepatitis C

Start: 2011-07-31End: 2014-06-30Updated: 2016-06-30

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)

CompletedNCT01343888

Boehringer IngelheimHepatitis C

Start: 2011-04-30End: 2014-03-31Updated: 2015-09-18

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

CompletedNCT01358864

Boehringer IngelheimHepatitis C, Chronic

Start: 2011-06-30End: 2014-05-31Updated: 2016-08-29

Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

CompletedNCT01399619

Boehringer IngelheimHepatitis C, Chronic

Start: 2011-09-30End: 2014-06-30Updated: 2016-08-29

A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection

WithdrawnNCT01608737

Boehringer IngelheimHepatitis C, Chronic

Start: 2012-09-30Updated: 2013-02-26

Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients

WithdrawnNCT01858961

Boehringer IngelheimHepatitis C, Chronic

Start: 2013-05-31End: 2016-07-31Updated: 2014-01-23

2016-05-262 citations

Faldaprevir, pegylated interferon, and ribavirin for treatment-naïve HCV genotype-1: pooled analysis of two phase 3 trials.

2016-05-011 citations

Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study

European Journal of Gastroenterology & Hepatology2016-04-302 citations

ITPA Genotypes Predict Anemia but Do Not Affect Virological Response with Interferon-Free Faldaprevir, Deleobuvir, and Ribavirin for HCV Infection

PLoS ONE2015-12-095 citations

Faldaprevir and pegylated interferon α-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV.

2015-03-0112 citations

Efficacy and Safety of Faldaprevir, Deleobuvir, and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C Virus Infection and Advanced Liver Fibrosis or Cirrhosis

Antimicrobial Agents and Chemotherapy2014-12-1513 citations

Effect of Steady-State Faldaprevir on the Pharmacokinetics of Steady-State Methadone and Buprenorphine-Naloxone in Subjects Receiving Stable Addiction Management Therapy

Antimicrobial Agents and Chemotherapy2014-11-117 citations

Effect of the Hepatitis C Virus Protease Inhibitor Faldaprevir on the Pharmacokinetics of an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel in Healthy Female Volunteers

Antimicrobial Agents and Chemotherapy2014-11-116 citations

SILEN-C3, a Phase 2 Randomized Trial with Faldaprevir plus Pegylated Interferon α-2a and Ribavirin in Treatment-Naive Hepatitis C Virus Genotype 1-Infected Patients

Antimicrobial Agents and Chemotherapy2014-04-0714 citations

Faldaprevir and Deleobuvir for HCV Genotype 1 Infection

New England Journal of Medicine2013-08-14223 citations

Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results.

2013-04-0427 citations

BI 201335

Sponsors

Conditions

Phase 1

Phase 2

Phase 3

Related Papers