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This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP-424 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-424 (generic name:Telaprevir) | Drug | 750mg q8h for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable HCV 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 |
|---|---|---|
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toranomon Hospital | Minato-ku | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25196718 | Result | Kumada H, Sato K, Takehara T, Nakamuta M, Ishigami M, Chayama K, Toyota J, Suzuki F, Nakayasu Y, Ochi M, Yamada I, Okanoue T. Efficacy of telaprevir-based therapy for difficult-to-treat patients with genotype 2 chronic hepatitis C in Japan. Hepatol Res. 2015 Jul;45(7):745-54. doi: 10.1111/hepr.12416. Epub 2014 Nov 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP-424 | MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP-424 | MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks |
| 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 (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 | MP-424 | MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 |
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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 |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C417083 | peginterferon alfa-2b |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Ribavirin |
| Drug |
400 - 1000 mg/day based on body weight for 24 weeks |
|
| Peginterferon alfa-2b | Drug | 1.5mcg/kg/week for 24 weeks |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 12 |
| 108 |
| 108 |
| 108 |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 16.0 |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.0 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.0 |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
|
| Renal impairment | Renal and urinary disorders | MedDRA 16.0 |
|
| Malaise | General disorders | MedDRA 16.0 |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.0 |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 |
|
| Headache | Nervous system disorders | MedDRA 16.0 |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.0 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 16.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
|
| Pyrexia | General disorders | MedDRA 16.0 |
|
| Malaise | General disorders | MedDRA 16.0 |
|
| Injection site erythema | General disorders | MedDRA 16.0 |
|
| Injection site reaction | General disorders | MedDRA 16.0 |
|
| Influenza like illness | General disorders | MedDRA 16.0 |
|
| Thirst | General disorders | MedDRA 16.0 |
|
| White blood cell count decreased | Investigations | MedDRA 16.0 |
|
| Platelet count decreased | Investigations | MedDRA 16.0 |
|
| Blood creatinine increased | Investigations | MedDRA 16.0 |
|
| Blood uric acid increased | Investigations | MedDRA 16.0 |
|
| Hyaluronic acid increased | Investigations | MedDRA 16.0 |
|
| Blood triglycerides increased | Investigations | MedDRA 16.0 |
|
| Blood bilirubin increased | Investigations | MedDRA 16.0 |
|
| Blood potassium decreased | Investigations | MedDRA 16.0 |
|
| Blood phosphorus decreased | Investigations | MedDRA 16.0 |
|
| Haemoglobin decreased | Investigations | MedDRA 16.0 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.0 |
|
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| 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 |