Trial Outcomes & Findings for Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C (NCT NCT00780416)
NCT ID: NCT00780416
Last Updated: 2026-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
189 participants
Primary outcome timeframe
After 24 weeks of follow-up
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
TRV/PEG/RBV
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
|
PEG/RBV
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 Study
STARTED
|
126
|
63
|
|
Overall Study
COMPLETED
|
114
|
54
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
| Measure |
TRV/PEG/RBV
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
|
PEG/RBV
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 Study
Physician Decision
|
3
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
Baseline Characteristics
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
TRV/PEG/RBV
n=126 Participants
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
|
PEG/RBV
n=63 Participants
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
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 10.4 • n=37 Participants
|
52.2 years
STANDARD_DEVIATION 9.7 • n=56 Participants
|
51.3 years
STANDARD_DEVIATION 10.2 • n=82 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=37 Participants
|
30 Participants
n=56 Participants
|
90 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=37 Participants
|
33 Participants
n=56 Participants
|
99 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: After 24 weeks of follow-upOutcome measures
| Measure |
TRV/PEG/RBV
n=126 Participants
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
|
PEG/RBV
n=63 Participants
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
|
|---|---|---|
|
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)
|
73.0 percentage of subjects achieving SVR
Interval 64.4 to 80.5
|
49.2 percentage of subjects achieving SVR
Interval 36.4 to 62.1
|
Adverse Events
TRV/PEG/RBV
Serious events: 15 serious events
Other events: 126 other events
Deaths: 0 deaths
PEG/RBV
Serious events: 6 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TRV/PEG/RBV
n=126 participants at risk
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
|
PEG/RBV
n=63 participants at risk
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
|
|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.79%
1/126
|
1.6%
1/63
|
|
Psychiatric disorders
Mania
|
0.79%
1/126
|
0.00%
0/63
|
|
Psychiatric disorders
Depression
|
0.00%
0/126
|
1.6%
1/63
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.79%
1/126
|
0.00%
0/63
|
|
Eye disorders
Cataract
|
0.79%
1/126
|
0.00%
0/63
|
|
Eye disorders
Anisometropia
|
0.00%
0/126
|
1.6%
1/63
|
|
Eye disorders
Macular hole
|
0.00%
0/126
|
1.6%
1/63
|
|
Eye disorders
Retinoschisis
|
0.00%
0/126
|
1.6%
1/63
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/126
|
1.6%
1/63
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
1/126
|
0.00%
0/63
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/126
|
1.6%
1/63
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/126
|
1.6%
1/63
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.79%
1/126
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.79%
1/126
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
Drug rash with eosinophilia and systemic symptoms
|
0.79%
1/126
|
0.00%
0/63
|
|
Infections and infestations
Gastroenteritis
|
0.79%
1/126
|
0.00%
0/63
|
|
Infections and infestations
Pharyngitis
|
0.79%
1/126
|
0.00%
0/63
|
|
Infections and infestations
Sepsis
|
0.79%
1/126
|
0.00%
0/63
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.79%
1/126
|
0.00%
0/63
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.79%
1/126
|
0.00%
0/63
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
2/126
|
0.00%
0/63
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.79%
1/126
|
0.00%
0/63
|
Other adverse events
| Measure |
TRV/PEG/RBV
n=126 participants at risk
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
|
PEG/RBV
n=63 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
18.3%
23/126
|
28.6%
18/63
|
|
Blood and lymphatic system disorders
Anaemia
|
89.7%
113/126
|
73.0%
46/63
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.5%
41/126
|
25.4%
16/63
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
15.9%
20/126
|
3.2%
2/63
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
6.3%
8/126
|
0.00%
0/63
|
|
Psychiatric disorders
Insomnia
|
31.7%
40/126
|
27.0%
17/63
|
|
Nervous system disorders
Headache
|
38.1%
48/126
|
50.8%
32/63
|
|
Nervous system disorders
Dysgeusia
|
27.0%
34/126
|
15.9%
10/63
|
|
Nervous system disorders
Dizziness
|
9.5%
12/126
|
11.1%
7/63
|
|
Nervous system disorders
Hypoaesthesia
|
7.9%
10/126
|
1.6%
1/63
|
|
Eye disorders
Retinopathy
|
8.7%
11/126
|
6.3%
4/63
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
14/126
|
9.5%
6/63
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
4.8%
6/126
|
6.3%
4/63
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.6%
7/126
|
4.8%
3/63
|
|
Gastrointestinal disorders
Diarrhoea
|
27.0%
34/126
|
30.2%
19/63
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
37/126
|
14.3%
9/63
|
|
Gastrointestinal disorders
Nausea
|
25.4%
32/126
|
11.1%
7/63
|
|
Gastrointestinal disorders
Abdominal discomfort
|
18.3%
23/126
|
19.0%
12/63
|
|
Gastrointestinal disorders
Stomatitis
|
19.0%
24/126
|
19.0%
12/63
|
|
Gastrointestinal disorders
Constipation
|
11.1%
14/126
|
20.6%
13/63
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.3%
8/126
|
11.1%
7/63
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.6%
7/126
|
3.2%
2/63
|
|
Gastrointestinal disorders
Cheilitis
|
4.0%
5/126
|
7.9%
5/63
|
|
Skin and subcutaneous tissue disorders
Rash
|
38.1%
48/126
|
28.6%
18/63
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.5%
51/126
|
46.0%
29/63
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
29.4%
37/126
|
3.2%
2/63
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.3%
23/126
|
20.6%
13/63
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
7.1%
9/126
|
3.2%
2/63
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
9/126
|
20.6%
13/63
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.3%
8/126
|
7.9%
5/63
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
9/126
|
6.3%
4/63
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
36/126
|
23.8%
15/63
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
21/126
|
19.0%
12/63
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
14/126
|
4.8%
3/63
|
|
General disorders
Pyrexia
|
77.8%
98/126
|
73.0%
46/63
|
|
General disorders
Malaise
|
57.9%
73/126
|
47.6%
30/63
|
|
General disorders
Injection site erythema
|
26.2%
33/126
|
33.3%
21/63
|
|
General disorders
Injection site reaction
|
23.0%
29/126
|
25.4%
16/63
|
|
General disorders
Influenza like illness
|
17.5%
22/126
|
25.4%
16/63
|
|
General disorders
Thirst
|
5.6%
7/126
|
1.6%
1/63
|
|
Investigations
White blood cell count decreased
|
68.3%
86/126
|
73.0%
46/63
|
|
Investigations
Platelet count decreased
|
64.3%
81/126
|
36.5%
23/63
|
|
Investigations
Blood uric acid increased
|
51.6%
65/126
|
7.9%
5/63
|
|
Investigations
Hyaluronic acid increased
|
50.8%
64/126
|
39.7%
25/63
|
|
Investigations
Blood creatinine increased
|
25.4%
32/126
|
0.00%
0/63
|
|
Investigations
Blood bilirubin increased
|
17.5%
22/126
|
20.6%
13/63
|
|
Investigations
Blood triglycerides increased
|
28.6%
36/126
|
17.5%
11/63
|
|
Investigations
Blood phosphorus decreased
|
12.7%
16/126
|
20.6%
13/63
|
|
Investigations
Neutrophil count decreased
|
14.3%
18/126
|
14.3%
9/63
|
|
Investigations
Blood potassium decreased
|
9.5%
12/126
|
3.2%
2/63
|
|
Investigations
Blood pressure increased
|
7.9%
10/126
|
3.2%
2/63
|
|
Investigations
High density lipoprotein decreased
|
6.3%
8/126
|
14.3%
9/63
|
|
Investigations
Protein total decreased
|
5.6%
7/126
|
4.8%
3/63
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
3.2%
4/126
|
7.9%
5/63
|
|
Injury, poisoning and procedural complications
Contusion
|
0.79%
1/126
|
9.5%
6/63
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER