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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (MP-424 High) | Experimental |
| |
| Group B (MP-424 Low) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-424(H), PEG-IFN-a-2b, RBV | Drug | MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum Observed Concentration in Plasma) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Data were collected at Day1 to Day85 |
| Tmax (Time of Maximum Concentration in Plasma) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Data were collected at Day1 to Day85 |
| AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Data were collected at Day1 to Day85 |
| Ctrough (Minimum Observed Concentration in Plasma) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Data were collected at Day1 to Day85 |
| T1/2(Time of Half-Life) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Data were collected at Day1 to Day85 |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels | HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL. | 37 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fumitaka Suzuki, MD | Department of Hepatology, Toranomon Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toranomon Hospital | Kawasaki | Takatsu-ku | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23190247 | Result | Suzuki F, Suzuki Y, Sezaki H, Akuta N, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Mineta R, Watahiki S, Kobayashi M, Nakayasu Y, Tsuda H, Aoki K, Yamada I, Kumada H. Exploratory study on telaprevir given every 8 h at 500 mg or 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients. Hepatol Res. 2013 Jul;43(7):691-701. doi: 10.1111/hepr.12009. Epub 2012 Nov 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (MP-424 High) | Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks |
| FG001 | Group B (MP-424 Low) | Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (MP-424 High) | Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks |
| BG001 | Group B (MP-424 Low) |
| 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 | Cmax (Maximum Observed Concentration in Plasma) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Posted | Mean | Standard Deviation | μg/mL | Data were collected at Day1 to Day85 |
|
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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 | Group A (MP-424 High) | Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| MP-424 (L), PEG-IFN-a-2b, RBV | Drug | MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks |
|
|
| stopping criteria |
|
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Tmax (Time of Maximum Concentration in Plasma) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Posted | Median | Full Range | hours | Data were collected at Day1 to Day85 |
|
|
|
| Primary | AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Posted | Mean | Standard Deviation | μg/mL | Data were collected at Day1 to Day85 |
|
|
|
| Primary | Ctrough (Minimum Observed Concentration in Plasma) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Posted | Mean | Standard Deviation | μg/mL | Data were collected at Day1 to Day85 |
|
|
|
| Primary | T1/2(Time of Half-Life) of MP-424 | Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57. | Posted | Mean | Standard Deviation | hours | Data were collected at Day1 to Day85 |
|
|
|
| Secondary | Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels | HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL. | Posted | Mean | Standard Deviation | Log IU / mL | 37 weeks |
|
|
|
| 2 |
| 10 |
| 10 |
| 10 |
| EG001 | Group B (MP-424 Low) | Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks | 2 | 10 | 10 | 10 |
| Appetite disorders | Metabolism and nutrition disorders | MedDRA 12.0 |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 12.0 |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 |
|
| Headache | Nervous system disorders | MedDRA 12.0 |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.0 |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 12.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 12.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
|
| Nocturia | Renal and urinary disorders | MedDRA 12.0 |
|
| Pyrexia | General disorders | MedDRA 12.0 |
|
| Malaise | General disorders | MedDRA 12.0 |
|
| Influenza like illness | General disorders | MedDRA 12.0 |
|
| Low density lipoprotein increased | Investigations | MedDRA 12.0 |
|
| Blood uric acid increased | Investigations | MedDRA 12.0 |
|
| Blood triglycerides increased | Investigations | MedDRA 12.0 |
|
| Blood creatinine increased | Investigations | MedDRA 12.0 |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.0 |
|
| Blood luteinising hormone increased | Investigations | MedDRA 12.0 |
|
| Eosinophil percentage increased | Investigations | MedDRA 12.0 |
|
| Lymphocyte percentage decreased | Investigations | MedDRA 12.0 |
|
| Blood cholesterol increased | Investigations | MedDRA 12.0 |
|
| Platelet count decreased | Investigations | MedDRA 12.0 |
|
| White blood cell count decreased | Investigations | MedDRA 12.0 |
|
| Protein urine present | Investigations | MedDRA 12.0 |
|
| Lymphocyte percentage increased | Investigations | MedDRA 12.0 |
|
| Blood potassium decreased | Investigations | MedDRA 12.0 |
|
| Neutrophil count decreased | Investigations | MedDRA 12.0 |
|
| Basophil percentage decreased | Investigations | MedDRA 12.0 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 |
|
| Blood bilirubin unconjugated increased | Investigations | MedDRA 12.0 |
|
| Lipids abnormal | Investigations | MedDRA 12.0 |
|
| Monocyte percentage increased | Investigations | MedDRA 12.0 |
|
| Bilirubin conjugated increased | Investigations | MedDRA 12.0 |
|
| Eosinophil percentage decreased | Investigations | MedDRA 12.0 |
|
| Protein total decreased | Investigations | MedDRA 12.0 |
|
| Blood albumin decreased | Investigations | MedDRA 12.0 |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 |
|
| Deafness | Ear and labyrinth disorders | MedDRA 12.0 |
|
| Cystitis | Infections and infestations | MedDRA 12.0 |
|
| Tinea pedis | Infections and infestations | MedDRA 12.0 |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.0 |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 12.0 |
|
| Frequent bowel movement | Gastrointestinal disorders | MedDRA 12.0 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 12.0 |
|
| Injection site erythema | General disorders | MedDRA 12.0 |
|
| Injection site reaction | General disorders | MedDRA 12.0 |
|
| Gout | Metabolism and nutrition disorders | MedDRA 12.0 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 |
|
| Syncope | Nervous system disorders | MedDRA 12.0 |
|
| Affective disorder | Psychiatric disorders | MedDRA 12.0 |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 |
|
| Depression | Psychiatric disorders | MedDRA 12.0 |
|
| Blood bilirubin increased | Investigations | MedDRA 12.0 |
|
| Blood calcium decreased | Investigations | MedDRA 12.0 |
|
| Blood glucose increased | Investigations | MedDRA 12.0 |
|
| Blood pressure decreased | Investigations | MedDRA 12.0 |
|
| Blood pressure increased | Investigations | MedDRA 12.0 |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 12.0 |
|
| C-reactive protein increased | Investigations | MedDRA 12.0 |
|
| Eosinophil count increased | Investigations | MedDRA 12.0 |
|
| High density lipoprotein decreased | Investigations | MedDRA 12.0 |
|
| Reticulocyte count increased | Investigations | MedDRA 12.0 |
|
| Neutrophil percentage decreased | Investigations | MedDRA 12.0 |
|
| Neutrophil percentage increased | Investigations | MedDRA 12.0 |
|
| Tri-iodothyronine free decreased | Investigations | MedDRA 12.0 |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Skin discomfort | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Tachycardia | Cardiac disorders | MedDRA 12.0 |
|
| Hypotension | Vascular disorders | MedDRA 12.0 |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 12.0 |
|
| Eye discharge | Eye disorders | MedDRA 12.0 |
|
| Visual impairment | Eye disorders | MedDRA 12.0 |
|
| Eye pruritus | Eye disorders | MedDRA 12.0 |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Choking sensation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.0 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 12.0 |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 |
|
Not provided
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Day 85 (Group A: 6 cases, Group B: 7 cases) |
|
| Day 85 (Group A: 6 cases, Group B: 7 cases) |
|
| Day85 (Group A: 6 cases, Group B:7cases) |
|
| Day85 (Group A: 6 cases, Group B: 7 cases) |
|
| Day 1_8h (Group A,B: 10 cases) |
|
| Day 1_16h (Group A,B: 10 cases) |
|
| Day 2 (Group A,B: 10 cases) |
|
| Day 3 (Group A,B: 10 cases) |
|
| Day 8 (Group A,B: 10 cases) |
|
| Day 14 (Group A,B: 10 cases) |
|
| Day 29 (Group A: 10 cases, Group B: 9 cases) |
|
| Day 43 (Group A: 8 cases, Group B: 8 cases) |
|
| Day 57 (Group A: 7 cases, Group B: 8 cases) |
|
| Day 86 (Group A: 6 cases, Group B: 7 cases) |
|
| Day 92 (Group A: 6 cases, Group B: 7 cases) |
|
| Day 99 (Group A: 6 cases, Group B: 7 cases) |
|
| Day 113 (Group A: 6 cases, Group B: 7 cases) |
|
| Day 141 (Group A: 6 cases, Group B: 7 cases) |
|
| Day 169 (Group A: 6 cases, Group B: 6 cases) |
|
| Day 197 (Group A: 6 cases, Group B: 6 cases) |
|
| Day 225 (Group A: 6 cases, Group B: 6 cases) |
|
| Day 253 (Group A: 6 cases, Group B: 6 cases) |
|