Trial Outcomes & Findings for Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C (NCT NCT01753557)
NCT ID: NCT01753557
Last Updated: 2026-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
48 weeks
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
Treatment-Naive
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
|
Treatment-Relapsed
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
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
19
|
|
Overall Study
COMPLETED
|
35
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
Baseline characteristics by cohort
| Measure |
Treatment-Naive
n=35 Participants
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
|
Treatment-Relapsed
n=19 Participants
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
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 10.5 • n=37 Participants
|
54.3 years
STANDARD_DEVIATION 9.5 • n=56 Participants
|
52.6 years
STANDARD_DEVIATION 10.1 • n=82 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=37 Participants
|
9 Participants
n=56 Participants
|
18 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=37 Participants
|
10 Participants
n=56 Participants
|
36 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Treatment-Naive
n=35 Participants
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
|
Treatment-Relapsed
n=19 Participants
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
|
|---|---|---|
|
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
|
85.7 percentage of subjects achieving SVR
Interval 69.7 to 95.2
|
94.7 percentage of subjects achieving SVR
Interval 74.0 to 99.9
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Treatment-Naive
n=35 Participants
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
|
Treatment-Relapsed
n=19 Participants
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
|
|---|---|---|
|
Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
|
88.6 percentage of subjects achieving RVR
Interval 73.3 to 96.8
|
100.0 percentage of subjects achieving RVR
Interval 82.4 to 100.0
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Treatment-Naive
n=35 Participants
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
|
Treatment-Relapsed
n=19 Participants
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
|
|---|---|---|
|
Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
|
97.1 percentage of subjects achieving ETR
Interval 85.1 to 99.9
|
100.0 percentage of subjects achieving ETR
Interval 82.4 to 100.0
|
SECONDARY outcome
Timeframe: 36 weeksOutcome measures
| Measure |
Treatment-Naive
n=35 Participants
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
|
Treatment-Relapsed
n=19 Participants
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
|
|---|---|---|
|
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
|
82.9 percentage of subjects achieving SVR12
Interval 66.4 to 93.4
|
94.7 percentage of subjects achieving SVR12
Interval 74.0 to 99.9
|
SECONDARY outcome
Timeframe: baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeksOutcome measures
| Measure |
Treatment-Naive
n=35 Participants
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
|
Treatment-Relapsed
n=19 Participants
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
|
|---|---|---|
|
Transition of Serum HCV RNA Levels
baseline (n=35,19)
|
6.70 log IU/mL
Interval 6.3 to 7.15
|
7.05 log IU/mL
Interval 6.3 to 7.3
|
|
Transition of Serum HCV RNA Levels
Day2 (n=35,19)
|
3.80 log IU/mL
Interval 3.6 to 4.2
|
4.00 log IU/mL
Interval 3.7 to 4.3
|
|
Transition of Serum HCV RNA Levels
Day3 (n=35,19)
|
3.10 log IU/mL
Interval 3.0 to 3.5
|
3.30 log IU/mL
Interval 3.0 to 3.5
|
|
Transition of Serum HCV RNA Levels
1Weeks (n=35,19)
|
2.00 log IU/mL
Interval 1.6 to 2.5
|
2.00 log IU/mL
Interval 1.7 to 2.5
|
|
Transition of Serum HCV RNA Levels
2Weeks (n=34,19)
|
1.00 log IU/mL
Interval 0.5 to 1.0
|
1.00 log IU/mL
Interval 0.5 to 1.3
|
|
Transition of Serum HCV RNA Levels
3Weeks (n=35,19)
|
0.50 log IU/mL
Interval 0.5 to 1.0
|
0.50 log IU/mL
Interval 0.5 to 1.0
|
|
Transition of Serum HCV RNA Levels
4Weeks (n=35,19)
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
|
Transition of Serum HCV RNA Levels
End of treatment (n=35,19)
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
|
Transition of Serum HCV RNA Levels
Follow-up 12Weeks (n=33,19)
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
|
Transition of Serum HCV RNA Levels
Follow-up 24Weeks (n=35,19)
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
0.50 log IU/mL
Interval 0.5 to 0.5
|
SECONDARY outcome
Timeframe: From baseline to 24 weeks after completion of drug administrationOutcome measures
| Measure |
Treatment-Naive
n=4 Participants
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
|
Treatment-Relapsed
n=1 Participants
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
|
|---|---|---|
|
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)
V36A
|
1 participants
|
0 participants
|
|
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)
T54A
|
0 participants
|
1 participants
|
|
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)
Not detected
|
3 participants
|
0 participants
|
Adverse Events
Treatment-Naive
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Treatment-Relapsed
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment-Naive
n=35 participants at risk
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
|
Treatment-Relapsed
n=19 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/35
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/35
|
5.3%
1/19
|
Other adverse events
| Measure |
Treatment-Naive
n=35 participants at risk
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
|
Treatment-Relapsed
n=19 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
40.0%
14/35
|
31.6%
6/19
|
|
Infections and infestations
Periodontitis
|
8.6%
3/35
|
10.5%
2/19
|
|
Blood and lymphatic system disorders
Anaemia
|
94.3%
33/35
|
100.0%
19/19
|
|
Endocrine disorders
Hypothyroidism
|
5.7%
2/35
|
10.5%
2/19
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
20.0%
7/35
|
42.1%
8/19
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.1%
6/35
|
57.9%
11/19
|
|
Psychiatric disorders
Insomnia
|
17.1%
6/35
|
26.3%
5/19
|
|
Nervous system disorders
Headache
|
42.9%
15/35
|
42.1%
8/19
|
|
Nervous system disorders
Dysgeusia
|
20.0%
7/35
|
21.1%
4/19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
2/35
|
26.3%
5/19
|
|
Gastrointestinal disorders
Diarrhoea
|
22.9%
8/35
|
15.8%
3/19
|
|
Gastrointestinal disorders
Nausea
|
20.0%
7/35
|
47.4%
9/19
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
5/35
|
36.8%
7/19
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
5/35
|
15.8%
3/19
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.4%
4/35
|
5.3%
1/19
|
|
Gastrointestinal disorders
Constipation
|
5.7%
2/35
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.1%
13/35
|
31.6%
6/19
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
31.4%
11/35
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.7%
9/35
|
26.3%
5/19
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
5/35
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.7%
2/35
|
15.8%
3/19
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.7%
2/35
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
2/35
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
5/35
|
36.8%
7/19
|
|
Renal and urinary disorders
Renal impairment
|
8.6%
3/35
|
10.5%
2/19
|
|
General disorders
Pyrexia
|
57.1%
20/35
|
52.6%
10/19
|
|
General disorders
Malaise
|
45.7%
16/35
|
63.2%
12/19
|
|
General disorders
Injection site erythema
|
40.0%
14/35
|
15.8%
3/19
|
|
General disorders
Injection site reaction
|
11.4%
4/35
|
21.1%
4/19
|
|
General disorders
Thirst
|
5.7%
2/35
|
10.5%
2/19
|
|
Investigations
White blood cell count decreased
|
82.9%
29/35
|
73.7%
14/19
|
|
Investigations
Platelet count decreased
|
82.9%
29/35
|
68.4%
13/19
|
|
Investigations
Blood uric acid increased
|
60.0%
21/35
|
31.6%
6/19
|
|
Investigations
Blood creatinine increased
|
51.4%
18/35
|
26.3%
5/19
|
|
Investigations
Blood bilirubin increased
|
22.9%
8/35
|
10.5%
2/19
|
|
Investigations
Blood triglycerides increased
|
17.1%
6/35
|
5.3%
1/19
|
|
Investigations
Hyaluronic acid increased
|
14.3%
5/35
|
21.1%
4/19
|
|
Investigations
Blood potassium decreased
|
5.7%
2/35
|
5.3%
1/19
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35
|
5.3%
1/19
|
|
Infections and infestations
Folliculitis
|
2.9%
1/35
|
5.3%
1/19
|
|
Infections and infestations
Hordeolum
|
2.9%
1/35
|
5.3%
1/19
|
|
Infections and infestations
Cystitis
|
0.00%
0/35
|
15.8%
3/19
|
|
Infections and infestations
Oral herpes
|
0.00%
0/35
|
10.5%
2/19
|
|
Infections and infestations
Furuncle
|
0.00%
0/35
|
5.3%
1/19
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/35
|
5.3%
1/19
|
|
Infections and infestations
Influenza
|
0.00%
0/35
|
5.3%
1/19
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/35
|
5.3%
1/19
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/35
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Lipid metabolism disorder
|
0.00%
0/35
|
5.3%
1/19
|
|
Psychiatric disorders
Depressive symptom
|
2.9%
1/35
|
5.3%
1/19
|
|
Nervous system disorders
Hypoaesthesia
|
5.7%
2/35
|
0.00%
0/19
|
|
Nervous system disorders
Dizziness
|
0.00%
0/35
|
10.5%
2/19
|
|
Nervous system disorders
Migraine
|
0.00%
0/35
|
5.3%
1/19
|
|
Nervous system disorders
Presyncope
|
0.00%
0/35
|
5.3%
1/19
|
|
Eye disorders
Retinopathy
|
22.9%
8/35
|
0.00%
0/19
|
|
Eye disorders
Vision blurred
|
2.9%
1/35
|
5.3%
1/19
|
|
Eye disorders
Asthenopia
|
5.7%
2/35
|
0.00%
0/19
|
|
Eye disorders
Eye pain
|
5.7%
2/35
|
0.00%
0/19
|
|
Eye disorders
Dry eye
|
2.9%
1/35
|
5.3%
1/19
|
|
Eye disorders
Retinal haemorrhage
|
2.9%
1/35
|
5.3%
1/19
|
|
Eye disorders
Cataract
|
0.00%
0/35
|
5.3%
1/19
|
|
Eye disorders
Eye discharge
|
0.00%
0/35
|
5.3%
1/19
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/35
|
5.3%
1/19
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/35
|
5.3%
1/19
|
|
Eye disorders
Eye pruritus
|
0.00%
0/35
|
5.3%
1/19
|
|
Ear and labyrinth disorders
Vertigo
|
5.7%
2/35
|
0.00%
0/19
|
|
Ear and labyrinth disorders
Ear pain
|
2.9%
1/35
|
5.3%
1/19
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/35
|
5.3%
1/19
|
|
Vascular disorders
Hypertension
|
2.9%
1/35
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
1/35
|
5.3%
1/19
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35
|
0.00%
0/19
|
|
Gastrointestinal disorders
Cheilitis
|
2.9%
1/35
|
10.5%
2/19
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/35
|
5.3%
1/19
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/35
|
5.3%
1/19
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/35
|
5.3%
1/19
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/35
|
5.3%
1/19
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/35
|
5.3%
1/19
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/35
|
21.1%
4/19
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/35
|
10.5%
2/19
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/35
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
2.9%
1/35
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
2.9%
1/35
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/35
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/35
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/35
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/35
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/35
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
2/35
|
0.00%
0/19
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/35
|
5.3%
1/19
|
|
General disorders
Oedema peripheral
|
5.7%
2/35
|
0.00%
0/19
|
|
General disorders
Feeling hot
|
2.9%
1/35
|
5.3%
1/19
|
|
Investigations
Liver function test abnormal
|
8.6%
3/35
|
0.00%
0/19
|
|
Investigations
Neutrophil count decreased
|
8.6%
3/35
|
0.00%
0/19
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.9%
1/35
|
10.5%
2/19
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.9%
1/35
|
5.3%
1/19
|
|
Investigations
Lymphocyte count decreased
|
2.9%
1/35
|
5.3%
1/19
|
|
Investigations
Blood phosphorus decreased
|
2.9%
1/35
|
5.3%
1/19
|
|
Investigations
Blood alkaline phosphatase increased
|
2.9%
1/35
|
5.3%
1/19
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/35
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
2.9%
1/35
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/35
|
5.3%
1/19
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER