Trial Outcomes & Findings for Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients (NCT NCT01468584)
NCT ID: NCT01468584
Last Updated: 2026-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
After 24 weeks of follow-up
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
MP-424
MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients
Baseline characteristics by cohort
| Measure |
MP-424
n=10 Participants
MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks
|
|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 6.7 • n=37 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: After 24 weeks of follow-upOutcome measures
| Measure |
MP-424
n=10 Participants
MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks
|
|---|---|
|
Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
|
50.0 percentage of subjects achieving SVR
Interval 18.7 to 81.3
|
Adverse Events
MP-424
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MP-424
n=10 participants at risk
MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks
Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks
Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
30.0%
3/10
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10
|
|
Blood and lymphatic system disorders
Anaemia
|
70.0%
7/10
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
4/10
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
20.0%
2/10
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10
|
|
Nervous system disorders
Headache
|
30.0%
3/10
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10
|
|
Nervous system disorders
Parosmia
|
10.0%
1/10
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10
|
|
Hepatobiliary disorders
Jaundice
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
2/10
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
20.0%
2/10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
2/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
10.0%
1/10
|
|
Renal and urinary disorders
Renal impairment
|
10.0%
1/10
|
|
General disorders
Injection site reaction
|
60.0%
6/10
|
|
General disorders
Malaise
|
40.0%
4/10
|
|
General disorders
Pyrexia
|
40.0%
4/10
|
|
General disorders
Injection site erythema
|
30.0%
3/10
|
|
General disorders
Chills
|
10.0%
1/10
|
|
General disorders
Injection site pruritus
|
10.0%
1/10
|
|
Investigations
Blood bilirubin increased
|
50.0%
5/10
|
|
Investigations
Blood uric acid increased
|
40.0%
4/10
|
|
Investigations
Platelet count decreased
|
40.0%
4/10
|
|
Investigations
White blood cell count decreased
|
30.0%
3/10
|
|
Investigations
Hyaluronic acid increased
|
30.0%
3/10
|
|
Investigations
Blood calcium decreased
|
10.0%
1/10
|
|
Investigations
Blood potassium decreased
|
10.0%
1/10
|
|
Investigations
Haemoglobin decreased
|
10.0%
1/10
|
|
Investigations
Liver function test abnormal
|
10.0%
1/10
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10
|
|
Investigations
Blood phosphorus decreased
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
10.0%
1/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER