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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004544-30 | EudraCT Number | EudraCT |
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The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically infected HCV GT1 treatment naïve patients, including patients with compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | BI 201335 in combination with BI 207127 and ribavirin for 24 weeks |
|
| Group 2 | Experimental | Telaprevir in combination with PegIFN and ribavirin for 24 weeks or 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 201335 | Drug | Once a day |
| |
| ribavirin |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response at Week 12 after end of treatment (SVR12) | at week 12 post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| SVR4: Plasma HCV RNA level <25 IU/mL1 at 4 weeks after end of treatment | at week 4 post treatment | |
| SVR24: Plasma HCV RNA level <25 IU/mL1 at 24 weeks after end of treatment | at week 4 post treatment |
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Inclusion criteria:
Chronic HCV, diagnosed by HCV RNA = 1,000 IU/mL at screening in addition to at least one of the following:
HCV infection of sub-GT1b confirmed by genotypic testing at screening.
Treatment naïve defined as:
Availability of a liver biopsy within three years or fibroscan within 6 months prior to randomisation.
Note: patients who do not have a liver biopsy (nor fibroscan) due to contraindication of the procedure should not be excluded for this reason. The decision on the inclusion of these patients should be discussed with the CML. Patients with a liver biopsy performed 3 or more years (or fibroscan performed 6 months or more) prior to randomisation, demonstrating cirrhosis do not need to repeat a liver biopsy or fibroscan.
Age 18 - 70 years (inclusive).
Female patients
Accepted methods of contraception for females in this trial are diaphragm with spermicide substances, intrauterine devices, cervical caps and condoms.
Note: Systemic hormonal contraceptives may not be as effective in women taking BI 207127/FDV combination therapy and are not accepted methods of contraception in the study.
OR:
Male patients
Signed informed consent form prior to trial participation.
Exclusion criteria:
Plus other exclusion criteria relating to Peg interferon, ribavirin and Telaprevir.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1241.37.61002 Boehringer Ingelheim Investigational Site | Westmead | New South Wales | Australia | |||
| 1241.37.61001 Boehringer Ingelheim Investigational Site |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C552340 | faldaprevir |
| D012254 | Ribavirin |
| C000592437 | deleobuvir |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Drug |
Twice a day |
|
| BI 207127 | Drug | Twice a day |
|
| Telaprevir | Drug | Three times a day |
|
| ribavirin | Drug | Twice a day |
|
| Pegylated Interferon | Drug | Once a week |
|
| Virological Response at Week 4 -Plasma HCV RNA level undetectable at Week 4 -Plasma HCV RNA level <25 IU/mL at Week 4 | at week 4 post treatment |
| Plasma HCV level undetectable at Week 12 | at week 12 |
| Time to achieving HCV RNA undetectable | up to week 48 |
| Virological breakthrough | up to week 48 |
| ETR: Plasma HCV RNA level undetected at the end of treatment | week 24 or 48 |
| Lack of on-treatment viral response | up to week 48 |
| Relapse | up to 48 weeks post treatment |
| Adverse events | up to week 48 post treatment |
| Adverse events leading to discontinuation | up to week 48 |
| Serious Adverse Events | up to week 48 post treatment |
| Laboratory test abnormalities by DAIDS grades | up to week 48 post treatment |
| Rate of red blood cell transfusion | up to week 48 post treatment |
| Time to discontinuation of trial medication | up to week 48 |
| Liver disease progression, fibroscan and FibroSURE | up to week 48 post treatment |
| Rate of ESA use | up to week 48 post treatment |
| Change in laboratory test values over time | up to week 48 post treatment |
| Patients requiring hospitalisation due to AEs related to study drugs | up to week 48 post treatment |
| Adelaide |
| South Australia |
| Australia |
| 1241.37.61003 Boehringer Ingelheim Investigational Site | Fitzroy | Victoria | Australia |
| 1241.37.34010 Boehringer Ingelheim Investigational Site | Alzira | Spain |
| 1241.37.34005 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1241.37.34002 Boehringer Ingelheim Investigational Site | L'Hospitalet Llobregat (bcn) | Spain |
| 1241.37.34001 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1241.37.34003 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1241.37.34004 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1241.37.34006 Boehringer Ingelheim Investigational Site | Valencia | Spain |
| 1241.37.46002 Boehringer Ingelheim Investigational Site | Lund | Sweden |
| 1241.37.46001 Boehringer Ingelheim Investigational Site | Stockholm | Sweden |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |