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This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-Naive | Experimental |
| |
| Treatment-Relapsed | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-424 | Drug | MP-424: 750mg every 8 hours (q8h) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) | 4 weeks | |
| Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazuoki Kondo, M.D. | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toranomon Hospital | Kawasaki | Takatsu-ku | 213-8587 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27062488 | Result | Kumada H, Suzuki F, Kamiya N, Orihashi M, Nakayasu Y, Yamada I. Efficacy and safety of telaprevir with pegylated interferon alpha-2a and ribavirin in Japanese patients. Hepatol Res. 2017 May;47(6):514-521. doi: 10.1111/hepr.12722. Epub 2016 Jun 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment-Naive | Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks |
| FG001 | Treatment-Relapsed | Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment-Naive | Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks |
| BG001 | Treatment-Relapsed |
| 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 (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | Posted | Number | 95% Confidence Interval | percentage of subjects achieving SVR | 48 weeks |
|
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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 | Treatment-Naive | Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 |
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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 |
|---|---|
| C100416 | peginterferon alfa-2a |
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| RBV | Drug | RBV: 600 - 1000 mg/day based on body weight for 24 weeks |
|
| PEG-IFN alfa-2a | Drug | PEG-IFN alfa-2a: 180mcg/week for 24 weeks |
|
| Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration | 36 weeks |
| Transition of Serum HCV RNA Levels | baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks |
| Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) | From baseline to 24 weeks after completion of drug administration |
Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) | Posted | Number | 95% Confidence Interval | percentage of subjects achieving RVR | 4 weeks |
|
|
|
| Secondary | Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) | Posted | Number | 95% Confidence Interval | percentage of subjects achieving ETR | 24 weeks |
|
|
|
| Secondary | Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration | Posted | Number | 95% Confidence Interval | percentage of subjects achieving SVR12 | 36 weeks |
|
|
|
| Secondary | Transition of Serum HCV RNA Levels | Posted | Median | Inter-Quartile Range | log IU/mL | baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks |
|
|
|
| Secondary | Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) | Posted | Number | participants | From baseline to 24 weeks after completion of drug administration |
|
|
|
| 0 |
| 35 |
| 35 |
| 35 |
| EG001 | Treatment-Relapsed | Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks | 2 | 19 | 19 | 19 |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 17.1 |
|
| Periodontitis | Infections and infestations | MedDRA 17.1 |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 |
|
| Hypothyroidism | Endocrine disorders | MedDRA 17.1 |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 17.1 |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 17.1 |
|
| Headache | Nervous system disorders | MedDRA 17.1 |
|
| Dysgeusia | Nervous system disorders | MedDRA 17.1 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 |
|
| Renal impairment | Renal and urinary disorders | MedDRA 17.1 |
|
| Pyrexia | General disorders | MedDRA 17.1 |
|
| Malaise | General disorders | MedDRA 17.1 |
|
| Injection site erythema | General disorders | MedDRA 17.1 |
|
| Injection site reaction | General disorders | MedDRA 17.1 |
|
| Thirst | General disorders | MedDRA 17.1 |
|
| White blood cell count decreased | Investigations | MedDRA 17.1 |
|
| Platelet count decreased | Investigations | MedDRA 17.1 |
|
| Blood uric acid increased | Investigations | MedDRA 17.1 |
|
| Blood creatinine increased | Investigations | MedDRA 17.1 |
|
| Blood bilirubin increased | Investigations | MedDRA 17.1 |
|
| Blood triglycerides increased | Investigations | MedDRA 17.1 |
|
| Hyaluronic acid increased | Investigations | MedDRA 17.1 |
|
| Blood potassium decreased | Investigations | MedDRA 17.1 |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 |
|
| Folliculitis | Infections and infestations | MedDRA 17.1 |
|
| Hordeolum | Infections and infestations | MedDRA 17.1 |
|
| Cystitis | Infections and infestations | MedDRA 17.1 |
|
| Oral herpes | Infections and infestations | MedDRA 17.1 |
|
| Furuncle | Infections and infestations | MedDRA 17.1 |
|
| Herpes simplex | Infections and infestations | MedDRA 17.1 |
|
| Influenza | Infections and infestations | MedDRA 17.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 17.1 |
|
| Enterocolitis viral | Infections and infestations | MedDRA 17.1 |
|
| Lipid metabolism disorder | Metabolism and nutrition disorders | MedDRA 17.1 |
|
| Depressive symptom | Psychiatric disorders | MedDRA 17.1 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.1 |
|
| Dizziness | Nervous system disorders | MedDRA 17.1 |
|
| Migraine | Nervous system disorders | MedDRA 17.1 |
|
| Presyncope | Nervous system disorders | MedDRA 17.1 |
|
| Retinopathy | Eye disorders | MedDRA 17.1 |
|
| Vision blurred | Eye disorders | MedDRA 17.1 |
|
| Asthenopia | Eye disorders | MedDRA 17.1 |
|
| Eye pain | Eye disorders | MedDRA 17.1 |
|
| Dry eye | Eye disorders | MedDRA 17.1 |
|
| Retinal haemorrhage | Eye disorders | MedDRA 17.1 |
|
| Cataract | Eye disorders | MedDRA 17.1 |
|
| Eye discharge | Eye disorders | MedDRA 17.1 |
|
| Punctate keratitis | Eye disorders | MedDRA 17.1 |
|
| Retinal vein occlusion | Eye disorders | MedDRA 17.1 |
|
| Eye pruritus | Eye disorders | MedDRA 17.1 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 17.1 |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 17.1 |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 17.1 |
|
| Hypertension | Vascular disorders | MedDRA 17.1 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 17.1 |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 |
|
| Glossitis | Gastrointestinal disorders | MedDRA 17.1 |
|
| Oral pain | Gastrointestinal disorders | MedDRA 17.1 |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 17.1 |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 17.1 |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 17.1 |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.1 |
|
| Palmoplantar keratoderma | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 17.1 |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 17.1 |
|
| Oedema peripheral | General disorders | MedDRA 17.1 |
|
| Feeling hot | General disorders | MedDRA 17.1 |
|
| Liver function test abnormal | Investigations | MedDRA 17.1 |
|
| Neutrophil count decreased | Investigations | MedDRA 17.1 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.1 |
|
| Lymphocyte count decreased | Investigations | MedDRA 17.1 |
|
| Blood phosphorus decreased | Investigations | MedDRA 17.1 |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 |
|
| Bilirubin conjugated increased | Investigations | MedDRA 17.1 |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 17.1 |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 17.1 |
|
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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 |
| Day3 (n=35,19) |
|
| 1Weeks (n=35,19) |
|
| 2Weeks (n=34,19) |
|
| 3Weeks (n=35,19) |
|
| 4Weeks (n=35,19) |
|
| End of treatment (n=35,19) |
|
| Follow-up 12Weeks (n=33,19) |
|
| Follow-up 24Weeks (n=35,19) |
|
| Not detected |
|