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Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT00780416
Recruitment Status : Completed
First Posted : October 27, 2008
Results First Posted : August 20, 2012
Last Update Posted : May 2, 2014
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: MP-424
Drug: Ribavirin
Drug: Peginterferon Alfa-2b
Enrollment 189
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TRV/PEG/RBV PEG/RBV
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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

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

Period Title: Overall Study
Started 126 63
Completed 114 54
Not Completed 12 9
Reason Not Completed
Physician Decision             3             3
Protocol Violation             1             0
Withdrawal by Subject             8             6
Arm/Group Title TRV/PEG/RBV PEG/RBV Total
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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

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

Total of all reporting groups
Overall Number of Baseline Participants 126 63 189
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 63 participants 189 participants
50.8  (10.4) 52.2  (9.7) 51.3  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 63 participants 189 participants
Female
60
  47.6%
30
  47.6%
90
  47.6%
Male
66
  52.4%
33
  52.4%
99
  52.4%
1.Primary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame After 24 weeks of follow-up
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title TRV/PEG/RBV PEG/RBV
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 126 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects achieving SVR
73.0
(64.4 to 80.5)
49.2
(36.4 to 62.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TRV/PEG/RBV PEG/RBV
Hide Arm/Group Description

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

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

All-Cause Mortality
TRV/PEG/RBV PEG/RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
TRV/PEG/RBV PEG/RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   15/126 (11.90%)   6/63 (9.52%) 
Blood and lymphatic system disorders     
Anaemia  2/126 (1.59%)  0/63 (0.00%) 
Pancytopenia  1/126 (0.79%)  0/63 (0.00%) 
Cardiac disorders     
Supraventricular tachycardia  0/126 (0.00%)  1/63 (1.59%) 
Eye disorders     
Cataract  1/126 (0.79%)  0/63 (0.00%) 
Anisometropia  0/126 (0.00%)  1/63 (1.59%) 
Macular hole  0/126 (0.00%)  1/63 (1.59%) 
Retinoschisis  0/126 (0.00%)  1/63 (1.59%) 
Gastrointestinal disorders     
Vomiting  1/126 (0.79%)  0/63 (0.00%) 
Colitis ischaemic  0/126 (0.00%)  1/63 (1.59%) 
Hepatobiliary disorders     
Cholecystitis  0/126 (0.00%)  1/63 (1.59%) 
Infections and infestations     
Gastroenteritis  1/126 (0.79%)  0/63 (0.00%) 
Pharyngitis  1/126 (0.79%)  0/63 (0.00%) 
Sepsis  1/126 (0.79%)  0/63 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1/126 (0.79%)  1/63 (1.59%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1/126 (0.79%)  0/63 (0.00%) 
Gastric cancer  1/126 (0.79%)  0/63 (0.00%) 
Nervous system disorders     
Carpal tunnel syndrome  1/126 (0.79%)  0/63 (0.00%) 
Psychiatric disorders     
Mania  1/126 (0.79%)  0/63 (0.00%) 
Depression  0/126 (0.00%)  1/63 (1.59%) 
Skin and subcutaneous tissue disorders     
Erythema multiforme  1/126 (0.79%)  0/63 (0.00%) 
Stevens-Johnson syndrome  1/126 (0.79%)  0/63 (0.00%) 
Drug rash with eosinophilia and systemic symptoms  1/126 (0.79%)  0/63 (0.00%) 
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TRV/PEG/RBV PEG/RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   126/126 (100.00%)   63/63 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  113/126 (89.68%)  46/63 (73.02%) 
Eye disorders     
Retinopathy  11/126 (8.73%)  4/63 (6.35%) 
Gastrointestinal disorders     
Diarrhoea  34/126 (26.98%)  19/63 (30.16%) 
Vomiting  37/126 (29.37%)  9/63 (14.29%) 
Nausea  32/126 (25.40%)  7/63 (11.11%) 
Abdominal discomfort  23/126 (18.25%)  12/63 (19.05%) 
Stomatitis  24/126 (19.05%)  12/63 (19.05%) 
Constipation  14/126 (11.11%)  13/63 (20.63%) 
Abdominal pain upper  8/126 (6.35%)  7/63 (11.11%) 
Haemorrhoids  7/126 (5.56%)  2/63 (3.17%) 
Cheilitis  5/126 (3.97%)  5/63 (7.94%) 
General disorders     
Pyrexia  98/126 (77.78%)  46/63 (73.02%) 
Malaise  73/126 (57.94%)  30/63 (47.62%) 
Injection site erythema  33/126 (26.19%)  21/63 (33.33%) 
Injection site reaction  29/126 (23.02%)  16/63 (25.40%) 
Influenza like illness  22/126 (17.46%)  16/63 (25.40%) 
Thirst  7/126 (5.56%)  1/63 (1.59%) 
Infections and infestations     
Nasopharyngitis  23/126 (18.25%)  18/63 (28.57%) 
Injury, poisoning and procedural complications     
Contusion  1/126 (0.79%)  6/63 (9.52%) 
Investigations     
White blood cell count decreased  86/126 (68.25%)  46/63 (73.02%) 
Platelet count decreased  81/126 (64.29%)  23/63 (36.51%) 
Blood uric acid increased  65/126 (51.59%)  5/63 (7.94%) 
Hyaluronic acid increased  64/126 (50.79%)  25/63 (39.68%) 
Blood creatinine increased  32/126 (25.40%)  0/63 (0.00%) 
Blood bilirubin increased  22/126 (17.46%)  13/63 (20.63%) 
Blood triglycerides increased  36/126 (28.57%)  11/63 (17.46%) 
Blood phosphorus decreased  16/126 (12.70%)  13/63 (20.63%) 
Neutrophil count decreased  18/126 (14.29%)  9/63 (14.29%) 
Blood potassium decreased  12/126 (9.52%)  2/63 (3.17%) 
Blood pressure increased  10/126 (7.94%)  2/63 (3.17%) 
High density lipoprotein decreased  8/126 (6.35%)  9/63 (14.29%) 
Protein total decreased  7/126 (5.56%)  3/63 (4.76%) 
Blood thyroid stimulating hormone decreased  4/126 (3.17%)  5/63 (7.94%) 
Metabolism and nutrition disorders     
Decreased appetite  41/126 (32.54%)  16/63 (25.40%) 
Hyperuricaemia  20/126 (15.87%)  2/63 (3.17%) 
Dyslipidaemia  8/126 (6.35%)  0/63 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  36/126 (28.57%)  15/63 (23.81%) 
Back pain  21/126 (16.67%)  12/63 (19.05%) 
Myalgia  14/126 (11.11%)  3/63 (4.76%) 
Nervous system disorders     
Headache  48/126 (38.10%)  32/63 (50.79%) 
Dysgeusia  34/126 (26.98%)  10/63 (15.87%) 
Dizziness  12/126 (9.52%)  7/63 (11.11%) 
Hypoaesthesia  10/126 (7.94%)  1/63 (1.59%) 
Psychiatric disorders     
Insomnia  40/126 (31.75%)  17/63 (26.98%) 
Respiratory, thoracic and mediastinal disorders     
Cough  14/126 (11.11%)  6/63 (9.52%) 
Oropharyngeal discomfort  6/126 (4.76%)  4/63 (6.35%) 
Upper respiratory tract inflammation  7/126 (5.56%)  3/63 (4.76%) 
Skin and subcutaneous tissue disorders     
Rash  48/126 (38.10%)  18/63 (28.57%) 
Alopecia  51/126 (40.48%)  29/63 (46.03%) 
Drug eruption  37/126 (29.37%)  2/63 (3.17%) 
Pruritus  23/126 (18.25%)  13/63 (20.63%) 
Pruritus generalised  9/126 (7.14%)  2/63 (3.17%) 
Erythema  9/126 (7.14%)  13/63 (20.63%) 
Eczema  8/126 (6.35%)  5/63 (7.94%) 
Dry skin  9/126 (7.14%)  4/63 (6.35%) 
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
EMail: cti-inq-ml@ml.mt-pharma.co.jp
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00780416    
Other Study ID Numbers: G060-A6
First Submitted: October 24, 2008
First Posted: October 27, 2008
Results First Submitted: June 5, 2012
Results First Posted: August 20, 2012
Last Update Posted: May 2, 2014