Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003535-27 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomised 24-week arm | Experimental | BI 207127 in combination with FDV and RBV for 24 weeks (randomised) |
|
| Randomised 16-week arm | Experimental | BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised) |
|
| Allocated 24-week arm | Experimental | BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 207127-placebo: 8-week treatment | Drug | 8 weeks of placebo treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SVR12 Rates With Historical Control | Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint. The number of participants analyzed are actually adjusted number of participant analyzed. | 12 Week (post-treatment) |
| Comparisons of SVR12 Rates Across Treatment Arms | Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint. | 12 Week (post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. | Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT. | 4 weeks (after End Of Treatment) |
| SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1241.36.00016 Boehringer Ingelheim Investigational Site | North Little Rock | Arkansas | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27920566 | Derived | Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 24-wk Non-cirrhotic (NC) Treatment Group | 24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients. |
| FG001 | 16-wk Non-cirrhotic (NC) Treatment Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Termination of DBV |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ribavirin: 24-week treatment |
| Drug |
24 weeks of active treatment |
|
| BI 207127: 24-week treatment | Drug | 24 weeks of active treatment |
|
| Faldaprevir: 24-week treatment | Drug | 24 weeks of active treatment |
|
| Faldaprevir: 24-week treatment | Drug | 24 weeks of active treatment |
|
| Ribavirin-placebo: 8-week treatment | Drug | 8 weeks of placebo treatment |
|
| BI 207127: 24-week treatment | Drug | 24 weeks of active treatment |
|
| Faldaprevir-placebo: 8-week treatment | Drug | 8 weeks of placebo treatment |
|
| Faldaprevir: 16-week treatment | Drug | 16 weeks of active treatment |
|
| Ribavirin: 16-week treatment | Drug | 16 weeks of active treatment |
|
| RBV: 24-week treatment | Drug | 24 weeks of active treatment |
|
| BI 207127: 16-week treatment | Drug | 16 weeks of active treatment |
|
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT. |
| 4 weeks (after End Of Treatment) |
| Prognostic Value of SVR12 Predicting SVR24 | The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed. | 24 Week (post-treatment) |
| 1241.36.00020 Boehringer Ingelheim Investigational Site |
| Anaheim |
| California |
| United States |
| 1241.36.00005 Boehringer Ingelheim Investigational Site | Bakersfield | California | United States |
| 1241.36.00009 Boehringer Ingelheim Investigational Site | La Jolla | California | United States |
| 1241.36.00007 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States |
| 1241.36.00013 Boehringer Ingelheim Investigational Site | Oceanside | California | United States |
| 1241.36.00019 Boehringer Ingelheim Investigational Site | San Diego | California | United States |
| 1241.36.00034 Boehringer Ingelheim Investigational Site | San Francisco | California | United States |
| 1241.36.00022 Boehringer Ingelheim Investigational Site | Bradenton | Florida | United States |
| 1241.36.00004 Boehringer Ingelheim Investigational Site | DeLand | Florida | United States |
| 1241.36.00006 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States |
| 1241.36.00003 Boehringer Ingelheim Investigational Site | Gainesville | Florida | United States |
| 1241.36.00010 Boehringer Ingelheim Investigational Site | Orlando | Florida | United States |
| 1241.36.00024 Boehringer Ingelheim Investigational Site | Palm Harbor | Florida | United States |
| 1241.36.00030 Boehringer Ingelheim Investigational Site | Zephyrhills | Florida | United States |
| 1241.36.00027 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States |
| 1241.36.00033 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 1241.36.00035 Boehringer Ingelheim Investigational Site | Springfield | Illinois | United States |
| 1241.36.00001 Boehringer Ingelheim Investigational Site | Valparaiso | Indiana | United States |
| 1241.36.00017 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana | United States |
| 1241.36.00018 Boehringer Ingelheim Investigational Site | Tupelo | Mississippi | United States |
| 1241.36.00043 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States |
| 1241.36.00032 Boehringer Ingelheim Investigational Site | Hillsborough | New Jersey | United States |
| 1241.36.00002 Boehringer Ingelheim Investigational Site | Arlington | Texas | United States |
| 1241.36.00039 Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
| 1241.36.00031 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1241.36.00008 Boehringer Ingelheim Investigational Site | Murray | Utah | United States |
| 1241.36.00026 Boehringer Ingelheim Investigational Site | Charlottesville | Virginia | United States |
| 1241.36.00044 Boehringer Ingelheim Investigational Site | Newport News | Virginia | United States |
| 1241.36.00015 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States |
| 1241.36.00029 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| 1241.36.61005 Boehringer Ingelheim Investigational Site | Camperdown | New South Wales | Australia |
| 1241.36.61010 Boehringer Ingelheim Investigational Site | Kogarah | New South Wales | Australia |
| 1241.36.61009 Boehringer Ingelheim Investigational Site | New Lambton | New South Wales | Australia |
| 1241.36.61007 Boehringer Ingelheim Investigational Site | Randwick | New South Wales | Australia |
| 1241.36.61002 Boehringer Ingelheim Investigational Site | Herston | Queensland | Australia |
| 1241.36.61004 Boehringer Ingelheim Investigational Site | Clayton | Victoria | Australia |
| 1241.36.61001 Boehringer Ingelheim Investigational Site | Darlinghurst | Victoria | Australia |
| 1241.36.61008 Boehringer Ingelheim Investigational Site | Heidelberg | Victoria | Australia |
| 1241.36.61006 Boehringer Ingelheim Investigational Site | Melbourne | Victoria | Australia |
| 1241.36.32006 Boehringer Ingelheim Investigational Site | Antwerp | Belgium |
| 1241.36.32001 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1241.36.32004 Boehringer Ingelheim Investigational Site | Edegem | Belgium |
| 1241.36.32005 Boehringer Ingelheim Investigational Site | Ghent | Belgium |
| 1241.36.32002 Boehringer Ingelheim Investigational Site | Leuven | Belgium |
| 1241.36.32003 Boehringer Ingelheim Investigational Site | Liège | Belgium |
| 1241.36.32007 Boehringer Ingelheim Investigational Site | Roeselare | Belgium |
| 1241.36.01005 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada |
| 1241.36.01006 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1241.36.01002 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba | Canada |
| 1241.36.01003 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1241.36.01001 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada |
| 1241.36.01004 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1241.36.01007 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1241.36.33001 Boehringer Ingelheim Investigational Site | Clichy | France |
| 1241.36.33004 Boehringer Ingelheim Investigational Site | Créteil | France |
| 1241.36.33002 Boehringer Ingelheim Investigational Site | Grenoble | France |
| 1241.36.33003 Boehringer Ingelheim Investigational Site | Paris | France |
| 1241.36.33008 Boehringer Ingelheim Investigational Site | Paris | France |
| 1241.36.33006 Boehringer Ingelheim Investigational Site | Saint-Laurent-du-Var | France |
| 1241.36.33005 Boehringer Ingelheim Investigational Site | Toulouse | France |
| 1241.36.33007 Boehringer Ingelheim Investigational Site | Villejuif | France |
| 1241.36.49011 Boehringer Ingelheim Investigational Site | Aachen | Germany |
| 1241.36.49001 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1241.36.49012 Boehringer Ingelheim Investigational Site | Dortmund | Germany |
| 1241.36.49004 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1241.36.49008 Boehringer Ingelheim Investigational Site | Erlangen | Germany |
| 1241.36.49009 Boehringer Ingelheim Investigational Site | Esslingen am Neckar | Germany |
| 1241.36.49014 Boehringer Ingelheim Investigational Site | Freiburg im Breisgau | Germany |
| 1241.36.49002 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1241.36.49007 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1241.36.49013 Boehringer Ingelheim Investigational Site | Tübingen | Germany |
| 1241.36.30001 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1241.36.30002 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1241.36.30003 Boehringer Ingelheim Investigational Site | Pátrai | Greece |
| 1241.36.30004 Boehringer Ingelheim Investigational Site | Rhodes | Greece |
| 1241.36.39025 Boehringer Ingelheim Investigational Site | Antella (fi) | Italy |
| 1241.36.39023 Boehringer Ingelheim Investigational Site | Bisceglie (bat) | Italy |
| 1241.36.39021 Boehringer Ingelheim Investigational Site | Bologna | Italy |
| 1241.36.39022 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 1241.36.39020 Boehringer Ingelheim Investigational Site | Palermo | Italy |
| 1241.36.39026 Boehringer Ingelheim Investigational Site | Pavia | Italy |
| 1241.36.39028 Boehringer Ingelheim Investigational Site | Pescara | Italy |
| 1241.36.39029 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1241.36.39024 Boehringer Ingelheim Investigational Site | San Giovanni Rotondo (fg) | Italy |
| 1241.36.64001 Boehringer Ingelheim Investigational Site | Auckland NZ | New Zealand |
| 1241.36.64002 Boehringer Ingelheim Investigational Site | Hamilton | New Zealand |
| 1241.36.35103 Boehringer Ingelheim Investigational Site | Barreiro | Portugal |
| 1241.36.35104 Boehringer Ingelheim Investigational Site | Coimbra | Portugal |
| 1241.36.35101 Boehringer Ingelheim Investigational Site | Lisbon | Portugal |
| 1241.36.34006 Boehringer Ingelheim Investigational Site | Badalona (Barcelona) | Spain |
| 1241.36.34002 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1241.36.34004 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1241.36.34001 Boehringer Ingelheim Investigational Site | L'Hospitalet Llobregat (bcn) | Spain |
| 1241.36.34005 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1241.36.34008 Boehringer Ingelheim Investigational Site | Málaga | Spain |
| 1241.36.34003 Boehringer Ingelheim Investigational Site | Seville | Spain |
| 1241.36.34007 Boehringer Ingelheim Investigational Site | Vigo (Pontevedra) | Spain |
| 1241.36.44003 Boehringer Ingelheim Investigational Site | Birmingham | United Kingdom |
| 1241.36.44006 Boehringer Ingelheim Investigational Site | Edinburgh | United Kingdom |
| 1241.36.44011 Boehringer Ingelheim Investigational Site | Hull | United Kingdom |
| 1241.36.44013 Boehringer Ingelheim Investigational Site | Leeds | United Kingdom |
| 1241.36.44008 Boehringer Ingelheim Investigational Site | Leicester | United Kingdom |
| 1241.36.44001 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1241.36.44005 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1241.36.44007 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom |
| 1241.36.44010 Boehringer Ingelheim Investigational Site | Newcastle upon Tyne | United Kingdom |
| 1241.36.44002 Boehringer Ingelheim Investigational Site | Oxford | United Kingdom |
| 1241.36.44004 Boehringer Ingelheim Investigational Site | Plymouth | United Kingdom |
Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients. |
| FG002 | 24-wk Cirrhotic (CR) Treatment Group | 24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Termination of FDV |
|
|
| Termination of RBV |
|
|
Full Analysis Set (FAS): This analysis set includes all randomized patients who were dispensed study medication and were documented to have taken at least one dose of any study medication, either active or placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 24-wk Non-cirrhotic (NC) Treatment Group | 24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients. |
| BG001 | 16-wk Non-cirrhotic (NC) Treatment Group | Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients. |
| BG002 | 24-wk Cirrhotic (CR) Treatment Group | 24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SVR12 Rates With Historical Control | Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint. The number of participants analyzed are actually adjusted number of participant analyzed. | Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment; | Posted | Number | percentage of participants | 12 Week (post-treatment) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Comparisons of SVR12 Rates Across Treatment Arms | Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint. | FAS | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 Week (post-treatment) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. | Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks (after End Of Treatment) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT. | Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks (after End Of Treatment) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Prognostic Value of SVR12 Predicting SVR24 | The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed. | FAS | Posted | Number | Percentage of participants | 24 Week (post-treatment) |
|
|
From first drug administration until 28 days after all treatment discontinuation, upto 226 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 24-wk Non-cirrhotic (NC) Treatment Group | 24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients. | 7 | 211 | 198 | 211 | ||
| EG001 | 16-wk Non-cirrhotic (NC) Treatment Group | Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients. | 12 | 213 | 202 | 213 | ||
| EG002 | 24-wk Cirrhotic (CR) Treatment Group | 24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients. | 8 | 72 | 66 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012254 | Ribavirin |
| C000592437 | deleobuvir |
| C552340 | faldaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Withdrawal by Subject |
|
| Other than stated |
|
| Adverse Event (Placebo Period) |
|
| Protocol Violation (Placebo Period) |
|
| Withdrawal by Subject |
|
| Other than stated |
|
| Adverse Event (Placebo Period) |
|
| Protocol Violation (Placebo Period) |
|
| Male |
|
| No |
| Superiority or Other |
| The proportion of patients achieving SVR12 achieved with 16 weeks of treatment of non-cirrhotic and 24 weeks of treatment of cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum. | z-test | A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed. | 0.0020 | Adjusted response rate | 75.89 | 2-Sided | 95 | 70.63 | 81.14 | No | Superiority or Other |
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|