Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003534-17 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
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To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort A CPA | Experimental | Cohort A CPA BI 207127/QD Faldaprevir Ribavirin |
|
| cohort A CPB | Experimental | Cohort B CPB BI 207127/QD Faldaprevir Ribavirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug | 24 Weeks |
| |
| BI 207127 high dose |
| Measure | Description | Time Frame |
|---|---|---|
| SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT) | Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage. | 12 weeks after End of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT) | Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage. | 4 weeks after End of Treatment |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1241.30.10003 Boehringer Ingelheim Investigational Site | La Mesa | California | United States | |||
| 1241.30.10007 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28030579 | Derived | Sarrazin C, Manns M, Calleja JL, Garcia-Samaniego J, Forns X, Kaste R, Bai X, Wu J, Stern JO. HCVerso3: An Open-Label, Phase IIb Study of Faldaprevir and Deleobuvir with Ribavirin in Hepatitis C Virus Genotype-1b-Infected Patients with Cirrhosis and Moderate Hepatic Impairment. PLoS One. 2016 Dec 28;11(12):e0168544. doi: 10.1371/journal.pone.0168544. eCollection 2016. |
Not provided
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This was phase IIb open label study of BI 207127 (Deleobuvir) in combination with faldaprevir and ribavirin in patients with mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection.
35 patients were enrolled and treated with Deleobuvir (DBV) / Faldaprevir (FDV) / Ribavirin (RBV): 18 patients with Child-Pugh A (mild hepatic impairment) and 17 patients with Child-Pugh B (moderate hepatic impairment).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm1: Child-Pugh A | Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks. |
| FG001 | Arm2: Child-Pugh B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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Not provided
Not provided
| Drug |
24 Weeks |
|
| Faldaprevir | Drug | 24 Weeks |
|
| Ribavirin | Drug | 24 Weeks |
|
| BI 207127 low dose | Drug | 24 Weeks |
|
| Faldaprevir | Drug | 24 Weeks |
|
| San Diego |
| California |
| United States |
| 1241.30.10001 Boehringer Ingelheim Investigational Site | DeLand | Florida | United States |
| 1241.30.10012 Boehringer Ingelheim Investigational Site | West Palm Beach | Florida | United States |
| 1241.30.10011 Boehringer Ingelheim Investigational Site | Arlington | Texas | United States |
| 1241.30.10002 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States |
| 1241.30.49002 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1241.30.49004 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1241.30.49005 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1241.30.49008 Boehringer Ingelheim Investigational Site | Bonn | Germany |
| 1241.30.49006 Boehringer Ingelheim Investigational Site | Frankfurt am Main | Germany |
| 1241.30.49001 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1241.30.49003 Boehringer Ingelheim Investigational Site | Leipzig | Germany |
| 1241.30.49007 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1241.30.34002 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1241.30.34005 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1241.30.34003 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1241.30.34001 Boehringer Ingelheim Investigational Site | Majadahonda (Madrid) | Spain |
| 1241.30.44002 Boehringer Ingelheim Investigational Site | London | United Kingdom |
Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
|
(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm1: Child-Pugh A | Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks. |
| BG001 | Arm2: Child-Pugh B | Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 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 | SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT) | Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage. | (Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 weeks after End of Treatment |
|
|
| ||||||||||||||||||||||||||||
| Secondary | SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT) | Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage. | (Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | 4 weeks after End of Treatment |
|
|
From first drug administration until last drug administration plus 28 days, up to 28 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm1: Child-Pugh A | Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks. | 1 | 18 | 17 | 18 | ||
| EG001 | Arm2: Child-Pugh B | Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks. | 9 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mucosal dryness | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gallbladder disorder | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatitis C RNA increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Waist circumference increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertonia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sensory loss | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bradyphrenia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Libido increased | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Onychalgia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vasospasm | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Because the company decided to stop the DBV development program, analyses for this trial were limited to the basic requirement for efficacy, and only the primary endpoint and secondary endpoint were analyzed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C000592437 | deleobuvir |
| C552340 | faldaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
|