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The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. BI 201335 low dose plus PegIFN/RBV | Experimental | low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients |
|
| 2. BI 201335 high dose plus PegIFN/RBV | Experimental | high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients |
|
| 3. BI 201335 high dose plus PegIFN/RBV | Experimental | high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients |
|
| 4. BI 201335 high dose plus PegIFN/RBV | Experimental | high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 201335 high dose | Drug | BI 201335 high dose with PegIFN/RBV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Investigator Defined Drug-related Adverse Events | Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) | Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration | EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60) |
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Inclusion criteria:
Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:
HCV genotype 1 infection confirmed by genotypic testing at screening
(For Cohort 1 only) Therapy-naïve to interferon, pegylated interferon, and ribavirin (For Cohort 2 only) Confirmed prior virological failure (null response, partial response, breakthrough or relapse) with an approved dose of PegIFN alfa/RBV or IFN beta/RBV for at least 12 weeks and with an 8-week washout period before screening
HCV RNA = 100,000 IU/mL at screening
Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)
Age 20 to 70 years
Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.
or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.
Signed informed consent form before trial participation
Exclusion criteria:
Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.54.08104 Boehringer Ingelheim Investigational Site | Chuo-ku, Chiba | Japan | ||||
| 1220.54.08118 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27153246 | Derived | Nishiguchi S, Urano Y, Suzaki K, Taniguchi A, Scherer J, Berger KL, Quinson AM, Stern JO, Omata M. Safety and efficacy of faldaprevir in combination with pegylated interferon alpha-2b and ribavirin in Japanese patients with genotype-1 chronic hepatitis C virus infection. Hepatol Res. 2017 Mar;47(3):E142-E151. doi: 10.1111/hepr.12741. Epub 2016 Aug 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients. |
| FG001 | Faldaprevir 240 mg q.d - Cohort I |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BI 201335 low dose |
| Drug |
BI 201335 low dose with PegIFN/RBV |
|
| BI 201335 high dose | Drug | BI 201335 high dose with PegIFN/RBV |
|
| BI 201335 high dose | Drug | BI 201335 high dose with PegIFN/RBV |
|
| Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) |
Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration |
| EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72) |
| Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 | Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8 | up to 8 weeks |
| Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | EOT (up to Week 24 or 48) |
| Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | EOT (up to Week 24 or 48) |
| Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | 12 weeks after the EOT (up to Week 36 or 60) |
| Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | 12 weeks after the EOT (up to Week 36 or 60) |
| Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | EOT (up to Week 24 or 48) |
| Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | EOT (up to Week 24 or 48) |
| Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | 12 weeks after the EOT (up to Week 36 or 60) |
| Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | 12 weeks after the EOT (up to Week 36 or 60) |
| Chuo-ku, Kobe, Hyogo |
| Japan |
| 1220.54.08108 Boehringer Ingelheim Investigational Site | Fukui, Fukui | Japan |
| 1220.54.08110 Boehringer Ingelheim Investigational Site | Gifu, Gifu | Japan |
| 1220.54.08105 Boehringer Ingelheim Investigational Site | Itabashi-ku, Tokyo | Japan |
| 1220.54.08112 Boehringer Ingelheim Investigational Site | Izunokuni, Shizuoka | Japan |
| 1220.54.08107 Boehringer Ingelheim Investigational Site | Kanazawa, Ishikawa | Japan |
| 1220.54.08120 Boehringer Ingelheim Investigational Site | Kita-gun, Kagawa | Japan |
| 1220.54.08109 Boehringer Ingelheim Investigational Site | Kofu, Yamanashi | Japan |
| 1220.54.08123 Boehringer Ingelheim Investigational Site | Kurume, Fukuoka | Japan |
| 1220.54.08121 Boehringer Ingelheim Investigational Site | Mtsuyama, Ehime | Japan |
| 1220.54.08113 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 1220.54.08117 Boehringer Ingelheim Investigational Site | Nishinomiya, Hyogo | Japan |
| 1220.54.08111 Boehringer Ingelheim Investigational Site | Ogaki, Gifu | Japan |
| 1220.54.08124 Boehringer Ingelheim Investigational Site | Oo Mura, Nagasaki, | Japan |
| 1220.54.08115 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1220.54.08116 Boehringer Ingelheim Investigational Site | Osakasayama, Osaka | Japan |
| 1220.54.08101 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1220.54.08102 Boehringer Ingelheim Investigational Site | Sendai, Miyagi | Japan |
| 1220.54.08119 Boehringer Ingelheim Investigational Site | Tanabe, Wakayama | Japan |
| 1220.54.08106 Boehringer Ingelheim Investigational Site | Toyama,Toyama | Japan |
| 1220.54.08114 Boehringer Ingelheim Investigational Site | Tsu, Mie | Japan |
| 1220.54.08122 Boehringer Ingelheim Investigational Site | Yahatanishi-ku, Kitakyusyu, Fukuoka | Japan |
| 1220.54.08125 Boehringer Ingelheim Investigational Site | Yamagata, Yamagata | Japan |
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. |
| FG002 | Relapser Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. |
| FG003 | Partial Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| FG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| FG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
FAS (All patients who were randomized and received at least 1 dose of the trial medication)
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| ID | Title | Description |
|---|---|---|
| BG000 | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. |
| BG001 | Faldaprevir 240 mg q.d - Cohort I | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. |
| BG002 | Relapser Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. |
| BG003 | Partial Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| BG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| BG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| BG006 | 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 | Number of Patients With Investigator Defined Drug-related Adverse Events | Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator. | Safety analyses were based on the safety analysis set (SAF) that included all patients who took the trial medication and were documented to have taken at least 1 dose of the trial medication. | Posted | Number | participants | Up to 52 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) | Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | 95% Confidence Interval | percentage of participants | EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60) |
| |||||||||||||||||||||||||||||||||
| Secondary | Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) | Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | 95% Confidence Interval | percentage of participants | EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72) |
| |||||||||||||||||||||||||||||||||
| Secondary | Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 | Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8 | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | percentage of participants | up to 8 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | participants | EOT (up to Week 24 or 48) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | participants | EOT (up to Week 24 or 48) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | participants | 12 weeks after the EOT (up to Week 36 or 60) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | participants | 12 weeks after the EOT (up to Week 36 or 60) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | participants | EOT (up to Week 24 or 48) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | participants | EOT (up to Week 24 or 48) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | participants | 12 weeks after the EOT (up to Week 36 or 60) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline | FAS (All patients who were randomized and received at least 1 dose of the trial medication) | Posted | Number | participants | 12 weeks after the EOT (up to Week 36 or 60) |
|
Up to 48 weeks + 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients. | 3 | 44 | 44 | 44 | ||
| EG001 | Faldaprevir 240 mg q.d - Cohort I | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients. | 4 | 43 | 43 | 43 | ||
| EG002 | Faldaprevir 240 mg q.d - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients. | 1 | 44 | 44 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Malaise | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Retinal exudates | Eye disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Retinopathy | Eye disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Malaise | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDDRA 16.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MEDDRA 16.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MEDDRA 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 16.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MEDDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 16.1 | 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 |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C552340 | faldaprevir |
Not provided
Not provided
Not provided
| Male |
|
| OG003 | Partial Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
| OG003 |
| Partial Responder Patients - Cohort II |
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
| OG003 |
| Partial Responder Patients - Cohort II |
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
| OG003 |
| Partial Responder Patients - Cohort II |
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
| OG003 |
| Partial Responder Patients - Cohort II |
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|
| OG003 |
| Partial Responder Patients - Cohort II |
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. |
| OG004 | Null Responder Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. |
| OG005 | Breakthrough Patients - Cohort II | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
|
|