Trial Outcomes & Findings for Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients (NCT NCT01466192)

NCT ID: NCT01466192

Last Updated: 2026-01-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 108 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	108
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	4

Reasons for withdrawal

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 Physician Decision	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients

Baseline characteristics by cohort

Measure	MP-424 n=108 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	56.1 years STANDARD_DEVIATION 8.0 • n=37 Participants
Sex: Female, Male Female	55 Participants n=37 Participants
Sex: Female, Male Male	53 Participants n=37 Participants

PRIMARY outcome

Timeframe: After 24 weeks of follow-up

Outcome measures

Measure	MP-424 n=108 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)	88.0 percentage of subjects achieving SVR Interval 80.3 to 93.4

Adverse Events

MP-424

Serious events: 12 serious events

Other events: 108 other events

Deaths: 0 deaths

Serious adverse events

Measure	MP-424 n=108 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.93% 1/108
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.93% 1/108
Metabolism and nutrition disorders Decreased appetite	1.9% 2/108
Gastrointestinal disorders Gastrointestinal disorder	0.93% 1/108
Gastrointestinal disorders Large intestine polyp	0.93% 1/108
Hepatobiliary disorders Hepatic function abnormal	0.93% 1/108
Skin and subcutaneous tissue disorders Erythema multiforme	0.93% 1/108
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.93% 1/108
Renal and urinary disorders Renal impairment	1.9% 2/108
General disorders Malaise	0.93% 1/108

Other adverse events

Measure	MP-424 n=108 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	38.9% 42/108
Blood and lymphatic system disorders Anaemia	79.6% 86/108
Metabolism and nutrition disorders Decreased appetite	50.0% 54/108
Metabolism and nutrition disorders Hyperuricaemia	25.9% 28/108
Metabolism and nutrition disorders Hypokalaemia	5.6% 6/108
Psychiatric disorders Insomnia	23.1% 25/108
Nervous system disorders Headache	44.4% 48/108
Nervous system disorders Dysgeusia	33.3% 36/108
Respiratory, thoracic and mediastinal disorders Cough	8.3% 9/108
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.4% 8/108
Gastrointestinal disorders Nausea	39.8% 43/108
Gastrointestinal disorders Abdominal discomfort	32.4% 35/108
Gastrointestinal disorders Vomiting	25.9% 28/108
Gastrointestinal disorders Diarrhoea	19.4% 21/108
Gastrointestinal disorders Stomatitis	16.7% 18/108
Gastrointestinal disorders Constipation	13.9% 15/108
Gastrointestinal disorders Cheilitis	11.1% 12/108
Skin and subcutaneous tissue disorders Rash	38.9% 42/108
Skin and subcutaneous tissue disorders Alopecia	30.6% 33/108
Skin and subcutaneous tissue disorders Drug eruption	23.1% 25/108
Skin and subcutaneous tissue disorders Pruritus	14.8% 16/108
Skin and subcutaneous tissue disorders Eczema	8.3% 9/108
Skin and subcutaneous tissue disorders Dry skin	6.5% 7/108
Musculoskeletal and connective tissue disorders Arthralgia	24.1% 26/108
Musculoskeletal and connective tissue disorders Back pain	9.3% 10/108
Musculoskeletal and connective tissue disorders Myalgia	6.5% 7/108
General disorders Pyrexia	79.6% 86/108
General disorders Malaise	65.7% 71/108
General disorders Injection site erythema	27.8% 30/108
General disorders Injection site reaction	22.2% 24/108
General disorders Influenza like illness	6.5% 7/108
General disorders Thirst	5.6% 6/108
Investigations White blood cell count decreased	63.0% 68/108
Investigations Platelet count decreased	56.5% 61/108
Investigations Blood creatinine increased	37.0% 40/108
Investigations Blood uric acid increased	36.1% 39/108
Investigations Hyaluronic acid increased	21.3% 23/108
Investigations Blood triglycerides increased	16.7% 18/108
Investigations Blood bilirubin increased	15.7% 17/108
Investigations Blood potassium decreased	8.3% 9/108
Investigations Blood phosphorus decreased	8.3% 9/108
Investigations Haemoglobin decreased	7.4% 8/108
Investigations Alanine aminotransferase increased	5.6% 6/108
Investigations Gamma-glutamyltransferase increased	5.6% 6/108

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: cti-inq-ml.JP@ml.tanabe-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER