Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012579-90 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
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Not provided
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short arm | Experimental | patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) |
|
| long arm | Experimental | patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 201335 | Drug | BI 201335 |
| |
| BI 201335 |
| Measure | Description | Time Frame |
|---|---|---|
| Virological Response at Week 28 (W28VR) | Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28. | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rapid Virological Response at Week 4 (RVR) | Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4. | 4 weeks |
| Virological Response at Week 24 (W24VR) |
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 |
|---|---|---|---|---|---|---|
| 1220.40.002 Boehringer Ingelheim Investigational Site | Tulepo | Mississippi | United States | |||
| 1220.40.007 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24709256 | Derived | Dieterich D, Asselah T, Guyader D, Berg T, Schuchmann M, Mauss S, Ratziu V, Ferenci P, Larrey D, Maieron A, Stern JO, Ozan M, Datsenko Y, Bocher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon alpha-2a and ribavirin in treatment-naive hepatitis C virus genotype 1-infected patients. Antimicrob Agents Chemother. 2014 Jun;58(6):3429-36. doi: 10.1128/AAC.02497-13. Epub 2014 Apr 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Faldaprevir 120mg (12 Weeks) | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
BI 201335 |
|
| Pegylated Interferon-alpha (IFN) | Drug | Pegylated Interferon-alpha |
|
| Ribavirin (RBV) | Drug | Ribavirin (RBV) |
|
virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24. |
| 24 weeks |
| Virological Response at Week 36 (W36VR) | Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36. | 36 weeks |
| End of Treatment Response (ETR) | End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy. | up to 48 weeks |
| Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy | Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy. | 72 weeks |
| Viral Load (HCV RNA) at All Visits During Treatment and Follow-up | Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits. | From baseline to 72 weeks |
| Time to Reach a Plasma HCV RNA Level BLD While on Treatment | Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment | 48 weeks |
| Laboratory Test Abnormalities and Study Medication Tolerabilities | Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic. | 48 weeks |
| Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination | No number of participants with clinically relevant abnormalities in vital signs and physical examination. | 48 weeks |
| Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) | Change from baseline (CFB) in Red blood cells. | baseline and 48 weeks |
| Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) | Change from baseline (CFB) in haematocrit and Eosinophils. | baseline and 48 weeks |
| Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) | Change from baseline (CFB) in Platelets and white blood cells. | baseline and 48 weeks |
| Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) | Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose. | baseline and 48 weeks |
| Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) | Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase. | baseline and 48 weeks |
| Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) | Change from baseline (CFB) in PT-INR (ratio). | baseline and 48 weeks |
| New York |
| New York |
| United States |
| 1220.40.006 Boehringer Ingelheim Investigational Site | Germantown | Tennessee | United States |
| 1220.40.004 Boehringer Ingelheim Investigational Site | Jackson | Tennessee | United States |
| 1220.40.003 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States |
| 1220.40.005 Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
| 1220.40.4303 Boehringer Ingelheim Investigational Site | Linz | Austria |
| 1220.40.4301 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1220.40.1004 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada |
| 1220.40.1001 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1220.40.1002 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada |
| 1220.40.1003 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 1220.40.1005 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 1220.40.3303A Boehringer Ingelheim Investigational Site | Clichy | France |
| 1220.40.3305A Boehringer Ingelheim Investigational Site | Lille | France |
| 1220.40.3301A Boehringer Ingelheim Investigational Site | Marseille | France |
| 1220.40.3306A Boehringer Ingelheim Investigational Site | Montpellier | France |
| 1220.40.3302A Boehringer Ingelheim Investigational Site | Paris | France |
| 1220.40.3304A Boehringer Ingelheim Investigational Site | Rennes | France |
| 1220.40.4902 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1220.40.4909 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1220.40.4906 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1220.40.4908 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1220.40.4904 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1220.40.4905 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1220.40.4001 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1220.40.4002 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1220.40.4003 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| FG001 | Faldaprevir 120mg (24 Weeks) | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): contained all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Faldaprevir 120 mg (12 Weeks) | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| BG001 | Faldaprevir 120 mg (24 Weeks) | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| BG002 | 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 | Virological Response at Week 28 (W28VR) | Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28. | Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations. | Posted | Number | participants | 28 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rapid Virological Response at Week 4 (RVR) | Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4. | PPS | Posted | Number | participants | 4 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virological Response at Week 24 (W24VR) | virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24. | PPS | Posted | Number | participants | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virological Response at Week 36 (W36VR) | Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36. | PPS | Posted | Number | participants | 36 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | End of Treatment Response (ETR) | End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy. | PPS | Posted | Number | participants | up to 48 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy | Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy. | PPS | Posted | Number | participants | 72 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Viral Load (HCV RNA) at All Visits During Treatment and Follow-up | Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits. | PPS | Posted | Mean | Standard Deviation | IU/mL | From baseline to 72 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach a Plasma HCV RNA Level BLD While on Treatment | Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment | PPS | Posted | Median | Inter-Quartile Range | week | 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Test Abnormalities and Study Medication Tolerabilities | Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic. | Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation. | Posted | Number | participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination | No number of participants with clinically relevant abnormalities in vital signs and physical examination. | TS | Posted | Number | participants with abnormality | 48 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) | Change from baseline (CFB) in Red blood cells. | TS | Posted | Mean | Standard Deviation | 10^12 cells/L | baseline and 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) | Change from baseline (CFB) in haematocrit and Eosinophils. | TS | Posted | Mean | Standard Deviation | % of laboratory test substance | baseline and 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) | Change from baseline (CFB) in Platelets and white blood cells. | TS | Posted | Mean | Standard Deviation | 10^9 cells/L | baseline and 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) | Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose. | TS | Posted | Mean | Standard Deviation | mmol/L | baseline and 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) | Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase. | TS | Posted | Mean | Standard Deviation | U/L | baseline and 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) | Change from baseline (CFB) in PT-INR (ratio). | TS | Posted | Mean | Standard Deviation | ratio | baseline and 48 weeks |
|
up to 24 weeks + 30 days washout.
One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.
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 | Faldaprevir 120 mg (12 Weeks) | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. | 3 | 80 | 73 | 80 | ||
| EG001 | Faldaprevir 120 mg (24 Weeks) | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). | 3 | 79 | 68 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Irritability | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | 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 |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
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