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Trial record 38 of 1270 for:    IFNA2

Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

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ClinicalTrials.gov Identifier: NCT01753557
Recruitment Status : Completed
First Posted : December 20, 2012
Results First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
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 (CHC)
Interventions Drug: MP-424
Drug: RBV
Drug: PEG-IFN alfa-2a
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment-Naive Treatment-Relapsed
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 35 19
Completed 35 19
Not Completed 0 0
Arm/Group Title Treatment-Naive Treatment-Relapsed Total
Hide Arm/Group Description 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 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 Total of all reporting groups
Overall Number of Baseline Participants 35 19 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 19 participants 54 participants
51.7  (10.5) 54.3  (9.5) 52.6  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 19 participants 54 participants
Female
9
  25.7%
9
  47.4%
18
  33.3%
Male
26
  74.3%
10
  52.6%
36
  66.7%
1.Primary Outcome
Title Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment-Naive Treatment-Relapsed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 35 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects achieving SVR
85.7
(69.7 to 95.2)
94.7
(74.0 to 99.9)
2.Secondary Outcome
Title Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment-Naive Treatment-Relapsed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 35 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects achieving RVR
88.6
(73.3 to 96.8)
100.0
(82.4 to 100.0)
3.Secondary Outcome
Title Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment-Naive Treatment-Relapsed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 35 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects achieving ETR
97.1
(85.1 to 99.9)
100.0
(82.4 to 100.0)
4.Secondary Outcome
Title Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Hide Description [Not Specified]
Time Frame 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment-Naive Treatment-Relapsed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 35 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects achieving SVR12
82.9
(66.4 to 93.4)
94.7
(74.0 to 99.9)
5.Secondary Outcome
Title Transition of Serum HCV RNA Levels
Hide Description [Not Specified]
Time Frame baseline,Day2,Day3,1Weeks,2Weeks,3Weeks,4Weeks,End of treatment,Follow-up 12weeks,Follow-up 24weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment-Naive Treatment-Relapsed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 35 19
Median (Inter-Quartile Range)
Unit of Measure: log IU/mL
baseline (n=35,19)
6.70
(6.30 to 7.15)
7.05
(6.30 to 7.30)
Day2 (n=35,19)
3.80
(3.60 to 4.20)
4.00
(3.70 to 4.30)
Day3 (n=35,19)
3.10
(3.00 to 3.50)
3.30
(3.00 to 3.50)
1Weeks (n=35,19)
2.00
(1.60 to 2.50)
2.00
(1.70 to 2.50)
2Weeks (n=34,19)
1.00
(0.50 to 1.00)
1.00
(0.50 to 1.30)
3Weeks (n=35,19)
0.50
(0.50 to 1.00)
0.50
(0.50 to 1.00)
4Weeks (n=35,19)
0.50
(0.50 to 0.50)
0.50
(0.50 to 0.50)
End of treatment (n=35,19)
0.50
(0.50 to 0.50)
0.50
(0.50 to 0.50)
Follow-up 12Weeks (n=33,19)
0.50
(0.50 to 0.50)
0.50
(0.50 to 0.50)
Follow-up 24Weeks (n=35,19)
0.50
(0.50 to 0.50)
0.50
(0.50 to 0.50)
6.Secondary Outcome
Title Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus(Result of Resistance-associated Variants Analysis)
Hide Description [Not Specified]
Time Frame From baseline to 24 weeks after completion of drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment-Naïve Treatment-Relapsed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 4 1
Measure Type: Number
Unit of Measure: participants
V36A 1 0
T54A 0 1
Not detected 3 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment-Naive Treatment-Relapsed
Hide Arm/Group Description 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 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
All-Cause Mortality
Treatment-Naive Treatment-Relapsed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment-Naive Treatment-Relapsed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   2/19 (10.53%) 
Musculoskeletal and connective tissue disorders     
Synovial cyst  0/35 (0.00%)  1/19 (5.26%) 
Skin and subcutaneous tissue disorders     
Pruritus generalised  0/35 (0.00%)  1/19 (5.26%) 
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment-Naive Treatment-Relapsed
Affected / at Risk (%) Affected / at Risk (%)
Total   35/35 (100.00%)   19/19 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  33/35 (94.29%)  19/19 (100.00%) 
Ear and labyrinth disorders     
Vertigo  2/35 (5.71%)  0/19 (0.00%) 
Ear pain  1/35 (2.86%)  1/19 (5.26%) 
Cerumen impaction  0/35 (0.00%)  1/19 (5.26%) 
Endocrine disorders     
Hypothyroidism  2/35 (5.71%)  2/19 (10.53%) 
Eye disorders     
Retinopathy  8/35 (22.86%)  0/19 (0.00%) 
Vision blurred  1/35 (2.86%)  1/19 (5.26%) 
Asthenopia  2/35 (5.71%)  0/19 (0.00%) 
Eye pain  2/35 (5.71%)  0/19 (0.00%) 
Dry eye  1/35 (2.86%)  1/19 (5.26%) 
Retinal haemorrhage  1/35 (2.86%)  1/19 (5.26%) 
Cataract  0/35 (0.00%)  1/19 (5.26%) 
Eye discharge  0/35 (0.00%)  1/19 (5.26%) 
Punctate keratitis  0/35 (0.00%)  1/19 (5.26%) 
Retinal vein occlusion  0/35 (0.00%)  1/19 (5.26%) 
Eye pruritus  0/35 (0.00%)  1/19 (5.26%) 
Gastrointestinal disorders     
Diarrhoea  8/35 (22.86%)  3/19 (15.79%) 
Nausea  7/35 (20.00%)  9/19 (47.37%) 
Stomatitis  5/35 (14.29%)  7/19 (36.84%) 
Vomiting  5/35 (14.29%)  3/19 (15.79%) 
Abdominal discomfort  4/35 (11.43%)  1/19 (5.26%) 
Constipation  2/35 (5.71%)  2/19 (10.53%) 
Dyspepsia  2/35 (5.71%)  0/19 (0.00%) 
Cheilitis  1/35 (2.86%)  2/19 (10.53%) 
Abdominal pain lower  0/35 (0.00%)  1/19 (5.26%) 
Abdominal pain upper  0/35 (0.00%)  1/19 (5.26%) 
Glossitis  0/35 (0.00%)  1/19 (5.26%) 
Oral pain  0/35 (0.00%)  1/19 (5.26%) 
Proctalgia  0/35 (0.00%)  1/19 (5.26%) 
General disorders     
Pyrexia  20/35 (57.14%)  10/19 (52.63%) 
Malaise  16/35 (45.71%)  12/19 (63.16%) 
Injection site erythema  14/35 (40.00%)  3/19 (15.79%) 
Injection site reaction  4/35 (11.43%)  4/19 (21.05%) 
Thirst  2/35 (5.71%)  2/19 (10.53%) 
Oedema peripheral  2/35 (5.71%)  0/19 (0.00%) 
Feeling hot  1/35 (2.86%)  1/19 (5.26%) 
Hepatobiliary disorders     
Hepatic function abnormal  0/35 (0.00%)  4/19 (21.05%) 
Hepatic steatosis  0/35 (0.00%)  2/19 (10.53%) 
Hyperbilirubinaemia  0/35 (0.00%)  1/19 (5.26%) 
Infections and infestations     
Nasopharyngitis  14/35 (40.00%)  6/19 (31.58%) 
Periodontitis  3/35 (8.57%)  2/19 (10.53%) 
Urinary tract infection  1/35 (2.86%)  1/19 (5.26%) 
Folliculitis  1/35 (2.86%)  1/19 (5.26%) 
Hordeolum  1/35 (2.86%)  1/19 (5.26%) 
Cystitis  0/35 (0.00%)  3/19 (15.79%) 
Oral herpes  0/35 (0.00%)  2/19 (10.53%) 
Furuncle  0/35 (0.00%)  1/19 (5.26%) 
Herpes simplex  0/35 (0.00%)  1/19 (5.26%) 
Influenza  0/35 (0.00%)  1/19 (5.26%) 
Pharyngitis  0/35 (0.00%)  1/19 (5.26%) 
Enterocolitis viral  0/35 (0.00%)  1/19 (5.26%) 
Injury, poisoning and procedural complications     
Arthropod sting  1/35 (2.86%)  1/19 (5.26%) 
Arthropod bite  0/35 (0.00%)  1/19 (5.26%) 
Investigations     
White blood cell count decreased  29/35 (82.86%)  14/19 (73.68%) 
Platelet count decreased  29/35 (82.86%)  13/19 (68.42%) 
Blood uric acid increased  21/35 (60.00%)  6/19 (31.58%) 
Blood creatinine increased  18/35 (51.43%)  5/19 (26.32%) 
Blood bilirubin increased  8/35 (22.86%)  2/19 (10.53%) 
Blood triglycerides increased  6/35 (17.14%)  1/19 (5.26%) 
Hyaluronic acid increased  5/35 (14.29%)  4/19 (21.05%) 
Blood potassium decreased  2/35 (5.71%)  1/19 (5.26%) 
Liver function test abnormal  3/35 (8.57%)  0/19 (0.00%) 
Neutrophil count decreased  3/35 (8.57%)  0/19 (0.00%) 
Gamma-glutamyltransferase increased  1/35 (2.86%)  2/19 (10.53%) 
Blood lactate dehydrogenase increased  1/35 (2.86%)  1/19 (5.26%) 
Lymphocyte count decreased  1/35 (2.86%)  1/19 (5.26%) 
Blood phosphorus decreased  1/35 (2.86%)  1/19 (5.26%) 
Blood alkaline phosphatase increased  1/35 (2.86%)  1/19 (5.26%) 
Bilirubin conjugated increased  0/35 (0.00%)  1/19 (5.26%) 
Metabolism and nutrition disorders     
Hyperuricaemia  7/35 (20.00%)  8/19 (42.11%) 
Decreased appetite  6/35 (17.14%)  11/19 (57.89%) 
Lipid metabolism disorder  0/35 (0.00%)  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  5/35 (14.29%)  7/19 (36.84%) 
Muscle spasms  2/35 (5.71%)  0/19 (0.00%) 
Nervous system disorders     
Headache  15/35 (42.86%)  8/19 (42.11%) 
Dysgeusia  7/35 (20.00%)  4/19 (21.05%) 
Hypoaesthesia  2/35 (5.71%)  0/19 (0.00%) 
Dizziness  0/35 (0.00%)  2/19 (10.53%) 
Migraine  0/35 (0.00%)  1/19 (5.26%) 
Presyncope  0/35 (0.00%)  1/19 (5.26%) 
Psychiatric disorders     
Insomnia  6/35 (17.14%)  5/19 (26.32%) 
Depressive symptom  1/35 (2.86%)  1/19 (5.26%) 
Renal and urinary disorders     
Renal impairment  3/35 (8.57%)  2/19 (10.53%) 
Pollakiuria  0/35 (0.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough  2/35 (5.71%)  5/19 (26.32%) 
Oropharyngeal pain  1/35 (2.86%)  1/19 (5.26%) 
Skin and subcutaneous tissue disorders     
Rash  13/35 (37.14%)  6/19 (31.58%) 
Drug eruption  11/35 (31.43%)  2/19 (10.53%) 
Alopecia  9/35 (25.71%)  5/19 (26.32%) 
Pruritus  5/35 (14.29%)  1/19 (5.26%) 
Rash maculo-papular  2/35 (5.71%)  3/19 (15.79%) 
Pruritus generalised  2/35 (5.71%)  2/19 (10.53%) 
Dry skin  2/35 (5.71%)  1/19 (5.26%) 
Palmoplantar keratoderma  1/35 (2.86%)  2/19 (10.53%) 
Dyshidrotic eczema  1/35 (2.86%)  1/19 (5.26%) 
Eczema asteatotic  0/35 (0.00%)  2/19 (10.53%) 
Erythema  0/35 (0.00%)  1/19 (5.26%) 
Erythema multiforme  0/35 (0.00%)  1/19 (5.26%) 
Papule  0/35 (0.00%)  1/19 (5.26%) 
Photosensitivity reaction  0/35 (0.00%)  1/19 (5.26%) 
Vascular disorders     
Hypertension  1/35 (2.86%)  1/19 (5.26%) 
1
Term from vocabulary, MedDRA 17.1
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: NCT01753557     History of Changes
Other Study ID Numbers: G060-A12
First Submitted: December 13, 2012
First Posted: December 20, 2012
Results First Submitted: June 14, 2016
Results First Posted: October 3, 2016
Last Update Posted: October 3, 2016