Trial Outcomes & Findings for Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C (NCT NCT00621296)
NCT ID: NCT00621296
Last Updated: 2026-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
MP-424
Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
MP-424
Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Unmatch Criteria
|
1
|
|
Overall Study
Stopping Criteria
|
3
|
Baseline Characteristics
Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
MP-424
n=15 Participants
Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
|
|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 6.7 • n=37 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.Outcome measures
| Measure |
MP-424
n=15 Participants
Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
|
|---|---|
|
Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration
|
1 participants
|
Adverse Events
MP-424
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MP-424
n=15 participants at risk
Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
|
|---|---|
|
Infections and infestations
Herpes zoster
|
6.7%
1/15
|
Other adverse events
| Measure |
MP-424
n=15 participants at risk
Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
46.7%
7/15
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
3/15
|
|
Nervous system disorders
Headache
|
20.0%
3/15
|
|
Nervous system disorders
Dysgeusia
|
20.0%
3/15
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
1/15
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
53.3%
8/15
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.7%
4/15
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.7%
1/15
|
|
Renal and urinary disorders
Nocturia
|
6.7%
1/15
|
|
General disorders
Oedema peripheral
|
6.7%
1/15
|
|
General disorders
Pyrexia
|
13.3%
2/15
|
|
General disorders
Malaise
|
6.7%
1/15
|
|
General disorders
Thirst
|
13.3%
2/15
|
|
Investigations
Low density lipoprotein increased
|
40.0%
6/15
|
|
Investigations
Blood uric acid increased
|
26.7%
4/15
|
|
Investigations
Blood triglycerides increased
|
13.3%
2/15
|
|
Investigations
Blood creatinine increased
|
13.3%
2/15
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.7%
1/15
|
|
Investigations
Platelet count decreased
|
13.3%
2/15
|
|
Investigations
Protein urine present
|
6.7%
1/15
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
1/15
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Blister
|
6.7%
1/15
|
|
General disorders
Oedema
|
6.7%
1/15
|
|
Investigations
Blood urine present
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
6.7%
1/15
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
2/15
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15
|
|
Gastrointestinal disorders
Periodontitis
|
6.7%
1/15
|
|
Investigations
White blood cell count decreased
|
6.7%
1/15
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER