9 completed, 3 terminated, 1 withdrawn. 8 Phase 1, 3 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 5, Terminated 3 |
| Phase 3 | 3 | Completed 2, Withdrawn 1 |
| Phase 2 | 2 | Completed 2 |
Follow deleobuvir: new trials by email Literature Review of deleobuvir trials Research Report on deleobuvir
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel faldaprevir, Microgynon®, BI 207127 - Healthy | Phase 1 | Terminated | Boehringer Ingelheim | 18 | 2013-11-01 | 2016-04-11 |
| Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects BI 207127 high fat, BI 207127 with Omeprazole, BI 207127 - Healthy | Phase 1 | Terminated | Boehringer Ingelheim | 16 | 2013-11-01 | 2016-05-16 |
| Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects. BI 207127, BI 207127 placebo, Faldaprevir placebo - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 48 | 2013-10-01 | 2016-04-14 |
| Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients BI 207127, faldaprevir - Renal Insufficiency | Phase 1 | Terminated | Boehringer Ingelheim | 4 | 2013-10-01 | 2016-04-11 |
| Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients BI 201335, ribavirin, BI 207127 - Hepatitis C, Chronic | Phase 3 | Withdrawn | Boehringer Ingelheim | 2013-05-01 | 2014-01-23 | |
| BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3 Ribavirin, BI 207127 high dose, Faldaprevir - Hepatitis C, Chronic | Phase 2 | Completed | Boehringer Ingelheim | 35 | 2013-04-01 | 2015-11-20 |
| IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1 Ribavirin (RBV), BI 201335 (Faldaprevir), BI 207127 - Hepatitis C, Chronic | Phase 3 | Completed | Boehringer Ingelheim | 470 | 2012-12-01 | 2016-04-18 |
| 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 BI 207127 + faldaprevir - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 32 | 2012-11-01 | 2016-04-08 |
| 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 BI 207127-placebo: 8-week treatment, Ribavirin: 24-week treatment, BI 207127: 24-week treatment - Hepatitis C, Chronic | Phase 3 | Completed | Boehringer Ingelheim | 496 | 2012-11-01 | 2016-02-12 |
| Drug Drug Interaction Study Between BI 201335 and BI 207127 in Chronic Hepatitis C Infected Patients midazolam, BI 201335, tenofovir - Hepatitis C, Chronic | Phase 1 | Completed | Boehringer Ingelheim | 72 | 2012-04-01 | 2016-06-10 |
| Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers BI 207127 - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 18 | 2012-02-01 | 2016-04-11 |
| 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 BI 207127, BI 201335, Ribavirin - Hepatitis C, Chronic | Phase 2 | Completed | Boehringer Ingelheim | 488 | 2010-05-01 | 2016-02-01 |
| 4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients BI 207127 middle dose +SOC, BI 207127 high dose+SOC, Placebo + SOC - Hepatitis C, Chronic | Phase 1 | Completed | Boehringer Ingelheim | 75 | 2009-05-01 | 2016-04-19 |
Hepatitis C, Chronic (7) · Renal Insufficiency (1)
Boehringer Ingelheim (13)
Germany (12) · Spain (5) · United States (5) · France (4) · Australia (3) · Canada (3) · Portugal (3) · United Kingdom (3) · Austria (2) · Italy (2) · New Zealand (2) · Romania (2) · Switzerland (2) · Belgium (1) · Greece (1)
PMID 27920566, PMID 22414766, PMID 23558093, PMID 23944300, PMID 25348520, PMID 25512403, PMID 26650626, PMID 27140229, PMID 28030579
2008 (1), 2009 (1)