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The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both treatment-naïve patients and patients previously treated with peginterferon and ribavirin were included. In addition, the effect of study medication was examined in a group of patients with liver cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 207127 in patients with cirrhosis | Experimental | multiple rising doses |
|
| BI 207127 in patients without cirrhosis | Experimental | multiple rising doses |
|
| Placebo in patients without cirrhosis | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 207127 NA | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Response (VR) | Virologic response was defined as a ≥ 1 log10 reduction in serum Hepatitis C virus (HCV) Ribonucleic acid (RNA) level from baseline at any time from the start of administration of treatment up to day 5. In this Outcome Measure the percentage of participants with virologic response is presented. | Baseline (Visit 2_2 at planned time 5 minutes prior to first administration of trial drug), up to day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Time Dependent Change From Baseline in Viral Load (VL) | Change of VL from baseline to day 7 is presented (VL at timepoint minus VL at baseline). Acronym used within the categories: planned time (PTM). The number of participants analysed displays the number of participants included in the analysis set whereas the number of participants for each timepoint display the number of participants with available data at that timepoint. |
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Inclusion Criteria:
Exclusion Criteria:
All fertile males not willing to use an adequate form of contraception (condom, sterilisation at least 6 months post operation) in case their partner is of childbearing potential and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/ implantable, intra-uterine device)
Patients who have been treated with at least one dose of any HCV-polymerase inhibitor for acute or chronic hepatitis C infection
Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
Decompensated liver disease within past 12 months, as indicated by variceal bleeding, ascites, encephalopathy, Prothrombin or International Normalized Ratio (INR) prolonged to >1.7 x upper limit of normal (ULN), serum bilirubin > 2 mg/dl or albumin < 3.5 g/dl (i.e. Child-Pugh grade B, score > 7)
For non-cirrhotic cohorts: Any previous liver biopsy consistent with cirrhosis. For cirrhotic cohorts: Any liver biopsy or fibroscan result from last 2 years excluding liver cirrhosis.
Positive test for human immunodeficiency virus (HIV) or hepatitis B antigen at screening
Current alcohol or drug abuse, or history of the same, within the past six (6) months. Exception: Occasional use of cannabis is not an exclusion criterion. The investigator must however instruct the patient that consumption of cannabis is not allowed during the treatment period.
Any concurrent disease (cardiovascular, pulmonary, renal, haematological, neurological, psychiatric, immunologic, metabolic or endocrine dysfunction) if clinically significant based on the investigator's medical assessment at screening. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study. Exclusion is also necessary for any pre-existing cardiac abnormality by history.
Clinically significant abnormalities at screening ECG, including but not limited to a QTc longer than 435 msec, Pulse Rate > 240 msec at baseline and any bundle branch block pattern, but not necessarily non-specific T wave abnormalities
History of malignancy (except for previously cured squamous cell or basal cell carcinoma)
Patients treated with any interferon (IFN) (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening
Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination from 7 days before treatment and during treatment
Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
Known hypersensitivity to drugs or excipients
Patients with any one of the following laboratory values at screening:
Alanine transaminase (ALT) > 3x ULN, local lab
Aspartate aminotransferase (AST) > 3x ULN, local lab
Total bilirubin > 1.5x ULN, local lab, unless predominantly conjugated and reflecting Gilbert's disease
Alkaline phosphatase > 1.5x ULN, local lab
Prothrombin time (INR) > 1.5x ULN, central lab
Creatinine > 1x ULN, local lab
Urine protein / creatinine ratio > 0.3 g protein / g creatinine, central lab
Alpha-1-microglobulin / creatinine in urine > 1x ULN, central lab
Platelet count < 100,000 / mm3, central lab
White Blood cell count < 2000 cells/mm3, central lab
Absolute neutrophile count < 1500 cells, central lab
Hemoglobin < 12 g/dL, central lab
For patients with liver cirrhosis:
Patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
Positive urine test for drug abuse at screening
Prior randomisation into this trial
Inability to comply with the protocol
Patients with ongoing or historical photosensitivity or recurrent rash
Alpha fetoprotein value (AFP) > 100 ng/ml; if AFP is > 20 and ≤ 100 ng/ml, patients can be included if liver cancer is excluded by a current imaging study (i.e. ultrasound, computer tomography scan or magnetic resonance imaging)
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Each patient participating in the trial (or the patient's legally accepted representative) provided written informed consent according to ICH GCP and the regulatory and legal requirements of the participating country. All subjects were informed that they were free to withdraw their consent at any time during the study without penalty or prejudice.
acronyms used in pre-assignment details: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP)
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Fibrosis | Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| FG001 | DBV 100mg Fibrosis | Deleobuvir (DBV) 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| FG002 | DBV 200mg Fibrosis | DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| FG003 | DBV 400mg Fibrosis | DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| FG004 | DBV 400mg Cirrhosis | DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis |
| FG005 | DBV 600mg Cirrhosis | DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis |
| FG006 | DBV 800mg Fibrosis | DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| FG007 | DBV 1200mg Fibrosis | DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of study treatment, regardless of randomisation. Full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Fibrosis | Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| BG001 | DBV 100mg Fibrosis | DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Virologic Response (VR) | Virologic response was defined as a ≥ 1 log10 reduction in serum Hepatitis C virus (HCV) Ribonucleic acid (RNA) level from baseline at any time from the start of administration of treatment up to day 5. In this Outcome Measure the percentage of participants with virologic response is presented. | The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Visit 2_2 at planned time 5 minutes prior to first administration of trial drug), up to day 5 |
|
Assessment of adverse events from the baseline up to 14 days
The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.
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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 | Placebo Fibrosis | Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug eruption | Skin and subcutaneous tissue disorders | MEDDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular disorder | Cardiac disorders | MEDDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Drug |
|
| Baseline, up to day 7 |
| Cmax | Maximum measured concentration of Deleobuvir in plasma (Cmax) determined after the first dose. | 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1 |
| Cmin | Measured concentration of Deleobuvir in plasma determined immediately before the second dose (Cmin). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1 |
| Tmax | Time from dosing to maximum measured concentration (tmax) of Deleobuvir determined after the first dose. | 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1 |
| AUC0-τ | Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ) measured after first administration of trial drug. | 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1 |
| Cmax,ss | The maximum measured concentration of Deleobuvir in plasma at steady state after the last dose of study drug (Cmax,ss). more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only) | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
| Cmin,ss | The minimum measured concentration of Deleobuvir in plasma at steady state (Cmin,ss). more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
| Tmax,ss | Time from dosing to the maximum measured concentration of Deleobuvir at steady state after the last dose of study drug (tmax,ss) more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only) | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
| AUCτ,ss | Area under the concentration-time curve of Deleobuvir in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) measured after last dose of trial drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
| AUC0-∞,ss | Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) extrapolated to infinity at steady state (AUC0-∞,ss) measured after last administration of trial drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
| λz,ss | Terminal rate of Deleobuvir constant in plasma at steady state (λz,ss) measured after last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
| t1/2,ss | Terminal half-life of Deleobuvir in plasma at steady state (t1/2,ss) measured after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
| CL/F,ss | Apparent clearance of Deleobuvir in plasma after oral administration at steady state (CL/F,ss) measured after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
| Vz/F,ss | Apparent volume of Deleobuvir distribution during the terminal phase λz following an oral dose at steady state (Vz/F,ss) after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
| Plasma Concentration Time Profiles | Individual drug plasma concentrations of Deleobuvir after multiple oral administration. Within the categories PTM means planned time. The number of participants analysed displays the number of participants included in the analysis data set whereas the number of participants for each timepoint displays the number of participants with available data at that timepoint. Below the limit of quantification (BLQ) is abbreviated. | up to day 7 |
| Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure). | Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure) presents the number of patients with an reported adverse event which has a symptom in changes in vital signs. Vascular disorders was identified as changes in vital signs. The number of participant with vascular disorders is presented in this outcome measure | Baseline, up to day 14 |
| Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram) | Number of patients with a new onset of an abnormal finding by central assessment are presented. | up to 14 days |
| Number of Patients With Abnormal Changes in Laboratory Tests | Number of patients with abnormal changes in safety laboratory tests including urine protein diagnostics, and adrenocorticotropic hormone (ACTH) and cortisol measurements resulted in adverse events. | Baseline, up to day 14 |
| Number of Patients With Adverse Events | Number of patients with any adverse event (AE) | up to 14 days |
| Number of Patients With Abnormal Findings in Physical Examination | The number of patients with abnormal findings in physical examination presents the number of patients with any treatment-emergent adverse events in this study. | up to day 14 |
| Assessment of Global Tolerability on a 4-point Scale | The global tolerability was presented on a four item scale: good, satisfactory, not satisfactory and bad. Rating was done by the investigator. | day 6 |
| Body Temperature | The body temperature will be presented as the mean values in visit 1 and visit 7. The number of participants analysed displays the number of participants included in the analysis set whereas the numbers for each timepoint display the number of participants with available data at that timepoint. | Visit 1, Visit 7 |
| not treated |
|
| BG002 | DBV 200mg Fibrosis | DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| BG003 | DBV 400mg Fibrosis | DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| BG004 | DBV 400mg Cirrhosis | DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis |
| BG005 | DBV 600mg Cirrhosis | DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis |
| BG006 | DBV 800mg Fibrosis | DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| BG007 | DBV 1200mg Fibrosis | DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| DBV 100mg Fibrosis |
DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| OG002 | DBV 200mg Fibrosis | DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| OG003 | DBV 400mg Fibrosis | DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| OG004 | DBV 400mg Cirrhosis | DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis |
| OG005 | DBV 600mg Cirrhosis | DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis |
| OG006 | DBV 800mg Fibrosis | DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
| OG007 | DBV 1200mg Fibrosis | DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis |
|
|
| Secondary | Time Dependent Change From Baseline in Viral Load (VL) | Change of VL from baseline to day 7 is presented (VL at timepoint minus VL at baseline). Acronym used within the categories: planned time (PTM). The number of participants analysed displays the number of participants included in the analysis set whereas the number of participants for each timepoint display the number of participants with available data at that timepoint. | The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication. | Posted | Mean | Standard Deviation | log10 (U/L) | Baseline, up to day 7 |
|
|
|
| Secondary | Cmax | Maximum measured concentration of Deleobuvir in plasma (Cmax) determined after the first dose. | The PK set (PKS) included all patients in the full analysis set (FAS) with evaluable PK data. FAS included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/millilitre (ng/mL) | 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1 |
|
|
|
| Secondary | Cmin | Measured concentration of Deleobuvir in plasma determined immediately before the second dose (Cmin). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1 |
|
|
|
| Secondary | Tmax | Time from dosing to maximum measured concentration (tmax) of Deleobuvir determined after the first dose. | PKS | Posted | Median | Full Range | hours (h) | 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1 |
|
|
|
| Secondary | AUC0-τ | Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ) measured after first administration of trial drug. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hours/millilitre (ng*h/mL) | 5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1 |
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|
| Secondary | Cmax,ss | The maximum measured concentration of Deleobuvir in plasma at steady state after the last dose of study drug (Cmax,ss). more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only) | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
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|
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| Secondary | Cmin,ss | The minimum measured concentration of Deleobuvir in plasma at steady state (Cmin,ss). more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
|
|
|
| Secondary | Tmax,ss | Time from dosing to the maximum measured concentration of Deleobuvir at steady state after the last dose of study drug (tmax,ss) more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only) | PKS | Posted | Median | Full Range | h | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
|
|
|
| Secondary | AUCτ,ss | Area under the concentration-time curve of Deleobuvir in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) measured after last dose of trial drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
|
|
|
| Secondary | AUC0-∞,ss | Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) extrapolated to infinity at steady state (AUC0-∞,ss) measured after last administration of trial drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
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| Secondary | λz,ss | Terminal rate of Deleobuvir constant in plasma at steady state (λz,ss) measured after last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | PKS | Posted | Median | Full Range | 1/h | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
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|
| Secondary | t1/2,ss | Terminal half-life of Deleobuvir in plasma at steady state (t1/2,ss) measured after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | PKS | Posted | Median | Full Range | h | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
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| Secondary | CL/F,ss | Apparent clearance of Deleobuvir in plasma after oral administration at steady state (CL/F,ss) measured after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Millilitre per minute (mL/min) | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
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|
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| Secondary | Vz/F,ss | Apparent volume of Deleobuvir distribution during the terminal phase λz following an oral dose at steady state (Vz/F,ss) after the last dose of study drug. more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Litre (L) | 5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter |
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|
|
| Secondary | Plasma Concentration Time Profiles | Individual drug plasma concentrations of Deleobuvir after multiple oral administration. Within the categories PTM means planned time. The number of participants analysed displays the number of participants included in the analysis data set whereas the number of participants for each timepoint displays the number of participants with available data at that timepoint. Below the limit of quantification (BLQ) is abbreviated. | The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | up to day 7 |
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| Secondary | Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure). | Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure) presents the number of patients with an reported adverse event which has a symptom in changes in vital signs. Vascular disorders was identified as changes in vital signs. The number of participant with vascular disorders is presented in this outcome measure | The treated set (TS) included 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 | Baseline, up to day 14 |
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|
|
| Secondary | Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram) | Number of patients with a new onset of an abnormal finding by central assessment are presented. | Treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation. Only patients included having no missing ECG measurements . | Posted | Number | participants | up to 14 days |
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| Secondary | Number of Patients With Abnormal Changes in Laboratory Tests | Number of patients with abnormal changes in safety laboratory tests including urine protein diagnostics, and adrenocorticotropic hormone (ACTH) and cortisol measurements resulted in adverse events. | The treated set (TS) included 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 | Baseline, up to day 14 |
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|
| Secondary | Number of Patients With Adverse Events | Number of patients with any adverse event (AE) | The treated set (TS) included 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 | up to 14 days |
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|
|
| Secondary | Number of Patients With Abnormal Findings in Physical Examination | The number of patients with abnormal findings in physical examination presents the number of patients with any treatment-emergent adverse events in this study. | The treated set (TS) included 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 | up to day 14 |
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|
| Secondary | Assessment of Global Tolerability on a 4-point Scale | The global tolerability was presented on a four item scale: good, satisfactory, not satisfactory and bad. Rating was done by the investigator. | The treated set (TS) included 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 | day 6 |
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|
| Secondary | Body Temperature | The body temperature will be presented as the mean values in visit 1 and visit 7. The number of participants analysed displays the number of participants included in the analysis set whereas the numbers for each timepoint display the number of participants with available data at that timepoint. | Treated set. | Posted | Mean | Standard Deviation | degree (°C) | Visit 1, Visit 7 |
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|
|
| 0 |
| 14 |
| 4 |
| 14 |
| EG001 | DBV 100mg Fibrosis | DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis | 0 | 9 | 2 | 9 |
| EG002 | DBV 200mg Fibrosis | DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis | 0 | 9 | 3 | 9 |
| EG003 | DBV 400mg Fibrosis | DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis | 0 | 9 | 7 | 9 |
| EG004 | DBV 400mg Cirrhosis | DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis | 0 | 8 | 5 | 8 |
| EG005 | DBV 600mg Cirrhosis | DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis | 0 | 5 | 4 | 5 |
| EG006 | DBV 800mg Fibrosis | DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis | 1 | 9 | 6 | 9 |
| EG007 | DBV 1200mg Fibrosis | DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis | 0 | 10 | 9 | 10 |
| Ear pain | Ear and labyrinth disorders | MEDDRA 12.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MEDDRA 12.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Faeces pale | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Lip disorder | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Asthenia | General disorders | MEDDRA 12.1 | Systematic Assessment |
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| Fatigue | General disorders | MEDDRA 12.1 | Systematic Assessment |
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| Gait disturbance | General disorders | MEDDRA 12.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MEDDRA 12.1 | Systematic Assessment |
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| Irritability | General disorders | MEDDRA 12.1 | Systematic Assessment |
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| Pain | General disorders | MEDDRA 12.1 | Systematic Assessment |
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| Pyrexia | General disorders | MEDDRA 12.1 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MEDDRA 12.1 | Systematic Assessment |
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| Urine colour abnormal | Investigations | MEDDRA 12.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 12.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 12.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 12.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MEDDRA 12.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MEDDRA 12.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 12.1 | Systematic Assessment |
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| Hyperaesthesia | Nervous system disorders | MEDDRA 12.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MEDDRA 12.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MEDDRA 12.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MEDDRA 12.1 | Systematic Assessment |
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| Stress | Psychiatric disorders | MEDDRA 12.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 12.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 12.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA 12.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 12.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MEDDRA 12.1 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MEDDRA 12.1 | Systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | MEDDRA 12.1 | Systematic Assessment |
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| Skin swelling | Skin and subcutaneous tissue disorders | MEDDRA 12.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MEDDRA 12.1 | Systematic Assessment |
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Other - 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.
| 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 |
| PTM 4:00 hours; N (per arm): 14/8/9/9/8/5/9/10 |
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| PTM 7:55 hours; N (per arm): 14/8/9/9/8/5/9/9 |
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| PTM 10:00 hours; N (per arm): 14/8/9/9/8/5/9/10 |
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| PTM 15:55 hours; N (per arm): 14/8/9/9/8/5/9/10 |
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| PTM 18:00 hours; N (per arm): 14/8/9/9/8/5/9/10 |
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| PTM 23:55 hours; N (per arm): 14/8/9/9/7/5/9/10 |
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| PTM 47:55 hours; N (per arm): 13/7/9/9/7/5/9/10 |
|
| PTM 71:55 hours; N (per arm): 14/8/9/8/7/5/9/10 |
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| PTM 95:55 hours; N (per arm): 14/8/9/8/7/5/9/10 |
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| PTM 98:00 hours; N (per arm): 14/8/9/8/8/5/9/10 |
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| PTM 100:00 hours; N (per arm): 14/8/9/8/7/5/8/10 |
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| PTM 104:00 hours; N (per arm): 13/8/9/8/0/0/8/10 |
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| PTM 108:00 hours; N (per arm): 14/8/9/8/8/5/8/10 |
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| PTM 112:00 hours; N (per arm): 14/8/9/8/6/5/8/10 |
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| PTM 120:00 hours; N (per arm): 14/8/9/8/6/5/8/10 |
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| PTM 144:00 hours; N (per arm): 14/8/9/8/0/1/6/10 |
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| PTM 1 hour; N(per Arm)=7/9/9/8/5/8/10) |
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| PTM 2 hours; N(per Arm)=9/9/9/8/5/9/10) |
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| PTM 3 hours; N(per Arm)=9/9/9/8/5/9/10) |
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| PTM 4 hours; N(per Arm)=9/9/9/8/5/9/10) |
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| PTM 6 hours; N(per Arm)=9/8/9/8/5/9/10) |
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| PTM 7.917 hours; N(per Arm)=8/8/9/8/5/9/10) |
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| PTM 10 hours; N(per Arm)=9/9/9/8/5/9/10) |
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| PTM 12 hours; N(per Arm)=9/9/9/8/5/9/10) |
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| PTM 15.917 hours; N(per Arm)=9/9/9/7/5/9/10) |
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| PTM 18 hours; N(per Arm)=9/9/9/8/5/9/10) |
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| PTM 23.917 hours; N(per Arm)=9/9/9/7/5/9/10) |
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| PTM 47.917 hours; N(per Arm)=9/9/9/7/5/9/10) |
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| PTM 71.917 hours; N(per Arm)=9/9/8/7/5/9/10) |
|
| PTM 95.917 hours; N(per Arm)=9/9/8/7/5/9/10) |
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| PTM 96.5 hours; N(per Arm)=9/9/8/7/5/9/10) |
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| PTM 97 hours; N(per Arm)=9/9/8/7/5/9/9) |
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| PTM 98 hours; N(per Arm)=9/9/8/7/5/9/10) |
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| PTM 99 hours; N(per Arm)=9/9/8/7/5/8/10) |
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| PTM 100 hours; N(per Arm)=9/9/8/7/5/8/10) |
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| PTM 102 hours; N(per Arm)=9/9/8/7/5/8/10) |
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| PTM 104 hours; N(per Arm)=9/9/8/7/5/7/10) |
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| PTM 106 hours; N(per Arm)=9/9/8/7/5/7/10) |
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| PTM 108 hours; N(per Arm)=9/9/8/7/5/7/10) |
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| PTM 112 hours; N(per Arm)=9/9/8/7/5/7/10) |
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| PTM 120 hours; N(per Arm)= 5/6/8/ 7/5/7/10) |
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| PTM 144 hours; N(per Arm)= 1/1/5/ 5/5/4/10) |
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| Sinus rhythm |
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| Conduction |
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| Morphology |
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| Myocardial infarction |
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| ST segment |
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| T-wave |
|
| U-wave |
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| Satisfactory |
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| Not satisfactory |
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| Bad |
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| Visit 7 (N=13/9/9/15/5/8/10) |
|