Trial Outcomes & Findings for Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy (NCT NCT00781274)
NCT ID: NCT00781274
Last Updated: 2026-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
32 participants
Primary outcome timeframe
After 24 weeks of follow-up
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
MP-424
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 Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
MP-424
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 Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy
Baseline characteristics by cohort
| Measure |
MP-424
n=32 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
|
|---|---|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 6.4 • n=37 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: After 24 weeks of follow-upOutcome measures
| Measure |
MP-424
n=32 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
|
|---|---|
|
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)
|
34.4 percentage of subjects achieving SVR
Interval 18.6 to 53.2
|
Adverse Events
MP-424
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MP-424
n=32 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
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
3.1%
1/32
|
|
General disorders
Malaise
|
3.1%
1/32
|
Other adverse events
| Measure |
MP-424
n=32 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
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32
|
|
Infections and infestations
Pharyngitis
|
6.2%
2/32
|
|
Infections and infestations
Cystitis
|
6.2%
2/32
|
|
Infections and infestations
Herpes zoster
|
6.2%
2/32
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
32/32
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
Decreased appetite
|
46.9%
15/32
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.2%
2/32
|
|
Psychiatric disorders
Insomnia
|
34.4%
11/32
|
|
Nervous system disorders
Headache
|
31.2%
10/32
|
|
Nervous system disorders
Dysgeusia
|
18.8%
6/32
|
|
Eye disorders
Dry eye
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
2/32
|
|
Gastrointestinal disorders
Diarrhoea
|
21.9%
7/32
|
|
Gastrointestinal disorders
Vomiting
|
21.9%
7/32
|
|
Gastrointestinal disorders
Nausea
|
12.5%
4/32
|
|
Gastrointestinal disorders
Abdominal discomfort
|
18.8%
6/32
|
|
Gastrointestinal disorders
Stomatitis
|
18.8%
6/32
|
|
Gastrointestinal disorders
Constipation
|
12.5%
4/32
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
2/32
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.2%
2/32
|
|
Gastrointestinal disorders
Proctalgia
|
9.4%
3/32
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
16/32
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.9%
7/32
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
31.2%
10/32
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.2%
2/32
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
4/32
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.6%
5/32
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
4/32
|
|
General disorders
Pyrexia
|
93.8%
30/32
|
|
General disorders
Malaise
|
68.8%
22/32
|
|
General disorders
Injection site erythema
|
6.2%
2/32
|
|
General disorders
Injection site reaction
|
9.4%
3/32
|
|
General disorders
Influenza like illness
|
6.2%
2/32
|
|
General disorders
Thirst
|
6.2%
2/32
|
|
General disorders
Injection site pruritus
|
9.4%
3/32
|
|
Investigations
White blood cell count decreased
|
68.8%
22/32
|
|
Investigations
Platelet count decreased
|
68.8%
22/32
|
|
Investigations
Blood uric acid increased
|
78.1%
25/32
|
|
Investigations
Hyaluronic acid increased
|
46.9%
15/32
|
|
Investigations
Blood creatinine increased
|
37.5%
12/32
|
|
Investigations
Blood bilirubin increased
|
31.2%
10/32
|
|
Investigations
Blood triglycerides increased
|
25.0%
8/32
|
|
Investigations
Blood phosphorus decreased
|
18.8%
6/32
|
|
Investigations
Blood potassium decreased
|
9.4%
3/32
|
|
Investigations
Laboratory test abnormal
|
9.4%
3/32
|
|
Investigations
Protein urine present
|
6.2%
2/32
|
|
Investigations
Low density lipoprotein increased
|
6.2%
2/32
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.2%
2/32
|
|
Investigations
Blood calcium decreased
|
6.2%
2/32
|
|
Investigations
Lipids abnormal
|
6.2%
2/32
|
|
Investigations
Transaminases increased
|
6.2%
2/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER