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Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT00621296
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : October 19, 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 Hepatitis C
Intervention Drug: MP-424 (Telaprevir)
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MP-424
Hide Arm/Group Description Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
Period Title: Overall Study
Started 15
Completed 1
Not Completed 14
Reason Not Completed
Adverse Event             2
Lack of Efficacy             1
Physician Decision             7
Unmatch Criteria             1
Stopping Criteria             3
Arm/Group Title MP-424
Hide Arm/Group Description Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
56.9  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
1.Primary Outcome
Title Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration
Hide Description [Not Specified]
Time Frame 24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MP-424
Hide Arm/Group Description:
Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
1
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 24 weeks Other Name: Telaprevir
All-Cause Mortality
MP-424
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MP-424
Affected / at Risk (%)
Total   1/15 (6.67%) 
Infections and infestations   
Herpes zoster  1/15 (6.67%) 
1
Term from vocabulary, MedDRA 12.0
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   14/15 (93.33%) 
Blood and lymphatic system disorders   
Anaemia  7/15 (46.67%) 
Gastrointestinal disorders   
Diarrhoea  2/15 (13.33%) 
Dyspepsia  1/15 (6.67%) 
Constipation  1/15 (6.67%) 
Nausea  1/15 (6.67%) 
Abdominal discomfort  1/15 (6.67%) 
Vomiting  1/15 (6.67%) 
Gastrooesophageal reflux disease  1/15 (6.67%) 
Gastrointestinal motility disorder  1/15 (6.67%) 
Abdominal pain upper  1/15 (6.67%) 
Periodontitis  1/15 (6.67%) 
General disorders   
Oedema peripheral  1/15 (6.67%) 
Pyrexia  2/15 (13.33%) 
Malaise  1/15 (6.67%) 
Thirst  2/15 (13.33%) 
Oedema  1/15 (6.67%) 
Infections and infestations   
Nasopharyngitis  2/15 (13.33%) 
Injury, poisoning and procedural complications   
Tooth fracture  1/15 (6.67%) 
Investigations   
Low density lipoprotein increased  6/15 (40.00%) 
Blood uric acid increased  4/15 (26.67%) 
Blood triglycerides increased  2/15 (13.33%) 
Blood creatinine increased  2/15 (13.33%) 
Blood lactate dehydrogenase increased  1/15 (6.67%) 
Platelet count decreased  2/15 (13.33%) 
Protein urine present  1/15 (6.67%) 
Blood urine present  1/15 (6.67%) 
White blood cell count decreased  1/15 (6.67%) 
Metabolism and nutrition disorders   
Anorexia  3/15 (20.00%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal stiffness  1/15 (6.67%) 
Nervous system disorders   
Headache  3/15 (20.00%) 
Dysgeusia  3/15 (20.00%) 
Dizziness  2/15 (13.33%) 
Psychiatric disorders   
Insomnia  1/15 (6.67%) 
Renal and urinary disorders   
Nocturia  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1/15 (6.67%) 
Skin and subcutaneous tissue disorders   
Rash  8/15 (53.33%) 
Pruritus  4/15 (26.67%) 
Rash pruritic  1/15 (6.67%) 
Blister  1/15 (6.67%) 
1
Term from vocabulary, MedDRA 12.0
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: NCT00621296     History of Changes
Other Study ID Numbers: G060-A7
First Submitted: February 12, 2008
First Posted: February 22, 2008
Results First Submitted: September 19, 2012
Results First Posted: October 19, 2012
Last Update Posted: May 2, 2014