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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRV/PEG/RBV | Experimental |
| |
| PEG/RBV | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-424 | Drug | 750 mg every 8 hours for 12 weeks |
|
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | After 24 weeks of follow-up |
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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 |
|---|---|---|---|
| 21827730 | Result | Kumada H, Toyota J, Okanoue T, Chayama K, Tsubouchi H, Hayashi N. Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan. J Hepatol. 2012 Jan;56(1):78-84. doi: 10.1016/j.jhep.2011.07.016. Epub 2011 Aug 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TRV/PEG/RBV | 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 24 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks |
| FG001 | PEG/RBV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ribavirin | Drug | 600 - 1000 mg/day based on body weight for 24 weeks |
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| Peginterferon Alfa-2b | Drug | 1.5 mcg/kg/week for 24 weeks |
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| Ribavirin | Drug | 600 - 1000 mg/day based on body weight for 48 weeks |
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| Peginterferon Alfa-2b | Drug | 1.5 mcg/kg/week for 48 weeks |
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Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TRV/PEG/RBV | 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 24 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks |
| BG001 | PEG/RBV | Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | Posted | Number | 95% Confidence Interval | percentage of subjects achieving SVR | After 24 weeks of follow-up |
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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 | TRV/PEG/RBV | 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 24 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks | 15 | 126 | 126 | 126 | ||
| EG001 | PEG/RBV | Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks | 6 | 63 | 63 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 13.0 |
| ||
| Pharyngitis | Infections and infestations | MedDRA 13.0 |
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| Sepsis | Infections and infestations | MedDRA 13.0 |
| ||
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 |
| ||
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.0 |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Mania | Psychiatric disorders | MedDRA 13.0 |
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| Depression | Psychiatric disorders | MedDRA 13.0 |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA 13.0 |
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| Cataract | Eye disorders | MedDRA 13.0 |
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| Anisometropia | Eye disorders | MedDRA 13.0 |
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| Macular hole | Eye disorders | MedDRA 13.0 |
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| Retinoschisis | Eye disorders | MedDRA 13.0 |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 13.0 |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 |
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| Colitis ischaemic | Gastrointestinal disorders | MedDRA 13.0 |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Drug rash with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Insomnia | Psychiatric disorders | MedDRA 13.0 |
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| Headache | Nervous system disorders | MedDRA 13.0 |
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| Dysgeusia | Nervous system disorders | MedDRA 13.0 |
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| Dizziness | Nervous system disorders | MedDRA 13.0 |
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| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 |
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| Retinopathy | Eye disorders | MedDRA 13.0 |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 |
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| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 |
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| Constipation | Gastrointestinal disorders | MedDRA 13.0 |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 |
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| Cheilitis | Gastrointestinal disorders | MedDRA 13.0 |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Pyrexia | General disorders | MedDRA 13.0 |
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| Malaise | General disorders | MedDRA 13.0 |
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| Injection site erythema | General disorders | MedDRA 13.0 |
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| Injection site reaction | General disorders | MedDRA 13.0 |
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| Influenza like illness | General disorders | MedDRA 13.0 |
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| Thirst | General disorders | MedDRA 13.0 |
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| White blood cell count decreased | Investigations | MedDRA 13.0 |
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| Platelet count decreased | Investigations | MedDRA 13.0 |
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| Blood uric acid increased | Investigations | MedDRA 13.0 |
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| Hyaluronic acid increased | Investigations | MedDRA 13.0 |
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| Blood creatinine increased | Investigations | MedDRA 13.0 |
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| Blood bilirubin increased | Investigations | MedDRA 13.0 |
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| Blood triglycerides increased | Investigations | MedDRA 13.0 |
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| Blood phosphorus decreased | Investigations | MedDRA 13.0 |
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| Neutrophil count decreased | Investigations | MedDRA 13.0 |
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| Blood potassium decreased | Investigations | MedDRA 13.0 |
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| Blood pressure increased | Investigations | MedDRA 13.0 |
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| High density lipoprotein decreased | Investigations | MedDRA 13.0 |
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| Protein total decreased | Investigations | MedDRA 13.0 |
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| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 13.0 |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C486464 | telaprevir |
| D012254 | Ribavirin |
| C417083 | peginterferon alfa-2b |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Male |
|