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Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy

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ClinicalTrials.gov Identifier: NCT00780910
Recruitment Status : Completed
First Posted : October 28, 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 Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: MP-424
Drug: Ribavirin
Drug: Peginterferon Alfa-2b
Enrollment 109
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MP-424
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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

Period Title: Overall Study
Started 109
Completed 107
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title MP-424
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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

Overall Number of Baseline Participants 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants
55.4  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
Female
43
  39.4%
Male
66
  60.6%
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MP-424
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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

Overall Number of Participants Analyzed 109
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects achieving SVR
88.1
(80.5 to 93.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MP-424
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

All-Cause Mortality
MP-424
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MP-424
Affected / at Risk (%)
Total   13/109 (11.93%) 
Blood and lymphatic system disorders   
Anaemia  1/109 (0.92%) 
General disorders   
Malaise  2/109 (1.83%) 
Irritability  1/109 (0.92%) 
Infections and infestations   
Sepsis  1/109 (0.92%) 
Injury, poisoning and procedural complications   
Wrist fracture  1/109 (0.92%) 
Skin laceration  1/109 (0.92%) 
Metabolism and nutrition disorders   
Decreased appetite  1/109 (0.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1/109 (0.92%) 
Gastric cancer  1/109 (0.92%) 
Nervous system disorders   
Syncope  1/109 (0.92%) 
Psychiatric disorders   
Anxiety  1/109 (0.92%) 
Delirium  1/109 (0.92%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1/109 (0.92%) 
Skin and subcutaneous tissue disorders   
Drug eruption  1/109 (0.92%) 
Rash  1/109 (0.92%) 
Stevens-Johnson syndrome  1/109 (0.92%) 
Toxic skin eruption  1/109 (0.92%) 
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MP-424
Affected / at Risk (%)
Total   109/109 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  95/109 (87.16%) 
Gastrointestinal disorders   
Diarrhoea  31/109 (28.44%) 
Vomiting  26/109 (23.85%) 
Nausea  24/109 (22.02%) 
Abdominal discomfort  22/109 (20.18%) 
Stomatitis  13/109 (11.93%) 
Constipation  15/109 (13.76%) 
Abdominal pain upper  7/109 (6.42%) 
General disorders   
Pyrexia  90/109 (82.57%) 
Malaise  59/109 (54.13%) 
Injection site erythema  16/109 (14.68%) 
Injection site reaction  16/109 (14.68%) 
Influenza like illness  15/109 (13.76%) 
Thirst  11/109 (10.09%) 
Infections and infestations   
Nasopharyngitis  19/109 (17.43%) 
Investigations   
White blood cell count decreased  83/109 (76.15%) 
Platelet count decreased  73/109 (66.97%) 
Blood uric acid increased  72/109 (66.06%) 
Hyaluronic acid increased  56/109 (51.38%) 
Blood creatinine increased  36/109 (33.03%) 
Blood bilirubin increased  34/109 (31.19%) 
Blood triglycerides increased  19/109 (17.43%) 
Blood phosphorus decreased  10/109 (9.17%) 
Neutrophil count decreased  8/109 (7.34%) 
Blood potassium decreased  8/109 (7.34%) 
Blood pressure increased  8/109 (7.34%) 
Laboratory test abnormal  10/109 (9.17%) 
Blood lactate dehydrogenase increased  9/109 (8.26%) 
Blood alkaline phosphatase increased  8/109 (7.34%) 
Blood cholesterol increased  6/109 (5.50%) 
Reticulocyte count decreased  6/109 (5.50%) 
Metabolism and nutrition disorders   
Decreased appetite  55/109 (50.46%) 
Dyslipidaemia  10/109 (9.17%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  18/109 (16.51%) 
Back pain  12/109 (11.01%) 
Myalgia  12/109 (11.01%) 
Nervous system disorders   
Headache  42/109 (38.53%) 
Dysgeusia  29/109 (26.61%) 
Psychiatric disorders   
Insomnia  34/109 (31.19%) 
Respiratory, thoracic and mediastinal disorders   
Cough  14/109 (12.84%) 
Oropharyngeal pain  8/109 (7.34%) 
Skin and subcutaneous tissue disorders   
Rash  38/109 (34.86%) 
Alopecia  35/109 (32.11%) 
Drug eruption  23/109 (21.10%) 
Pruritus  20/109 (18.35%) 
Pruritus generalised  10/109 (9.17%) 
Erythema  8/109 (7.34%) 
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
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00780910     History of Changes
Other Study ID Numbers: G060-A8
First Submitted: October 24, 2008
First Posted: October 28, 2008
Results First Submitted: June 5, 2012
Results First Posted: August 20, 2012
Last Update Posted: May 2, 2014