Trial Outcomes & Findings for Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy (NCT NCT00780910)
NCT ID: NCT00780910
Last Updated: 2026-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
109 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
|
109
|
|
Overall Study
COMPLETED
|
107
|
|
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
Adverse Event
|
2
|
Baseline Characteristics
Efficacy and Safety of MP-424, Peginterferon Alfa-2b, and Ribavirin in Patients With Chronic Hepatitis C Who Relapsed After Previous Interferon Based Therapy
Baseline characteristics by cohort
| Measure |
MP-424
n=109 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 8.6 • n=37 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: After 24 weeks of follow-upOutcome measures
| Measure |
MP-424
n=109 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)
|
88.1 percentage of subjects achieving SVR
Interval 80.5 to 93.5
|
Adverse Events
MP-424
Serious events: 13 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MP-424
n=109 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
Sepsis
|
0.92%
1/109
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.92%
1/109
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.92%
1/109
|
|
Blood and lymphatic system disorders
Anaemia
|
0.92%
1/109
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.92%
1/109
|
|
Psychiatric disorders
Anxiety
|
0.92%
1/109
|
|
Psychiatric disorders
Delirium
|
0.92%
1/109
|
|
Nervous system disorders
Syncope
|
0.92%
1/109
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.92%
1/109
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.92%
1/109
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.92%
1/109
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.92%
1/109
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.92%
1/109
|
|
General disorders
Malaise
|
1.8%
2/109
|
|
General disorders
Irritability
|
0.92%
1/109
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.92%
1/109
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.92%
1/109
|
Other adverse events
| Measure |
MP-424
n=109 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
|
17.4%
19/109
|
|
Blood and lymphatic system disorders
Anaemia
|
87.2%
95/109
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.5%
55/109
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
9.2%
10/109
|
|
Psychiatric disorders
Insomnia
|
31.2%
34/109
|
|
Nervous system disorders
Headache
|
38.5%
42/109
|
|
Nervous system disorders
Dysgeusia
|
26.6%
29/109
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.8%
14/109
|
|
Gastrointestinal disorders
Diarrhoea
|
28.4%
31/109
|
|
Gastrointestinal disorders
Vomiting
|
23.9%
26/109
|
|
Gastrointestinal disorders
Nausea
|
22.0%
24/109
|
|
Gastrointestinal disorders
Abdominal discomfort
|
20.2%
22/109
|
|
Gastrointestinal disorders
Stomatitis
|
11.9%
13/109
|
|
Gastrointestinal disorders
Constipation
|
13.8%
15/109
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.4%
7/109
|
|
Skin and subcutaneous tissue disorders
Rash
|
34.9%
38/109
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
32.1%
35/109
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
21.1%
23/109
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.3%
20/109
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
9.2%
10/109
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.3%
8/109
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
18/109
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.0%
12/109
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.0%
12/109
|
|
General disorders
Pyrexia
|
82.6%
90/109
|
|
General disorders
Malaise
|
54.1%
59/109
|
|
General disorders
Injection site erythema
|
14.7%
16/109
|
|
General disorders
Injection site reaction
|
14.7%
16/109
|
|
General disorders
Influenza like illness
|
13.8%
15/109
|
|
General disorders
Thirst
|
10.1%
11/109
|
|
Investigations
White blood cell count decreased
|
76.1%
83/109
|
|
Investigations
Platelet count decreased
|
67.0%
73/109
|
|
Investigations
Blood uric acid increased
|
66.1%
72/109
|
|
Investigations
Hyaluronic acid increased
|
51.4%
56/109
|
|
Investigations
Blood creatinine increased
|
33.0%
36/109
|
|
Investigations
Blood bilirubin increased
|
31.2%
34/109
|
|
Investigations
Blood triglycerides increased
|
17.4%
19/109
|
|
Investigations
Blood phosphorus decreased
|
9.2%
10/109
|
|
Investigations
Neutrophil count decreased
|
7.3%
8/109
|
|
Investigations
Blood potassium decreased
|
7.3%
8/109
|
|
Investigations
Blood pressure increased
|
7.3%
8/109
|
|
Investigations
Laboratory test abnormal
|
9.2%
10/109
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.3%
9/109
|
|
Investigations
Blood alkaline phosphatase increased
|
7.3%
8/109
|
|
Investigations
Blood cholesterol increased
|
5.5%
6/109
|
|
Investigations
Reticulocyte count decreased
|
5.5%
6/109
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.3%
8/109
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER