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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP-424 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-424 (Telaprevir) | Drug | Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration | 24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug. |
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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 |
|---|---|---|---|
| 23383655 | Result | Toyota J, Ozeki I, Karino Y, Asahina Y, Izumi N, Takahashi S, Kawakami Y, Chayama K, Kamiya N, Aoki K, Yamada I, Suzuki Y, Suzuki F, Kumada H. Virological response and safety of 24-week telaprevir alone in Japanese patients infected with hepatitis C virus subtype 1b. J Viral Hepat. 2013 Mar;20(3):167-73. doi: 10.1111/j.1365-2893.2012.01640.x. Epub 2012 Jul 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP-424 | Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP-424 | Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir |
| 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 | Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration | Posted | Number | participants | 24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug. |
|
|
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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 | MP-424 | Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA 12.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 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 |
|---|---|
| C486464 | telaprevir |
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| Unmatch Criteria |
|
| Stopping Criteria |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 1 |
| 15 |
| 14 |
| 15 |
| Anorexia | Metabolism and nutrition 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 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Nocturia | Renal and urinary disorders | MedDRA 12.0 |
|
| Oedema peripheral | General disorders | MedDRA 12.0 |
|
| Pyrexia | General disorders | MedDRA 12.0 |
|
| Malaise | General disorders | MedDRA 12.0 |
|
| Thirst | 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 |
|
| Platelet count decreased | Investigations | MedDRA 12.0 |
|
| Protein urine present | Investigations | MedDRA 12.0 |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 12.0 |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Oedema | General disorders | MedDRA 12.0 |
|
| Blood urine present | Investigations | MedDRA 12.0 |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 12.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 12.0 |
|
| White blood cell count decreased | Investigations | MedDRA 12.0 |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 |
|
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| 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 |