Hepatitis CPhase 1NCT00630058

A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C

A Phase 1 study testing MP-424(H), PEG-IFN-a-2b, RBV and MP-424 (L), PEG-IFN-a-2b, RBV in people with Hepatitis C, run by Tanabe Pharma Corporation at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Hepatitis C
What is being tested?: MP-424(H), PEG-IFN-a-2b, RBV and MP-424 (L), PEG-IFN-a-2b, RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteJapan
Study dates: Apr 2008to Mar 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with genotype 1b chronic hepatitis C

Who cannot join

Patients diagnosed with decompensated cirrhosis
Patients diagnosed with positive HBs antigen in the test

Trial locations and contacts

1 site in 1 country.

Japan1 site

Toranomon Hospital
Kawasaki, Takatsu-ku

Other trials in Japan

About this study

Official title: A Phase I, Open-Label, Two-Arm Study of MP-424 in Combination With Peginterferon Alfa 2b and Ribavirin in Patients With Genotype 1b Hepatitis C

Conditions: Hepatitis C
Being tested: MP-424(H), PEG-IFN-a-2b, RBV, MP-424 (L), PEG-IFN-a-2b, RBV
Keywords: Chronic Hepatitis C, Protease Inhibitor, Telaprevir
Medical subject headings: Hepatitis C, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MP-424(H), PEG-IFN-a-2b, RBVDrug
Also called Telaprevir
MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
MP-424 (L), PEG-IFN-a-2b, RBVDrug
Also called Telaprevir
MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Study groups in NCT00630058
Study group	Role	What they receive
Group A (MP-424 High)	Experimental	Not described Receives: Drug: MP-424(H), PEG-IFN-a-2b, RBV
Group B (MP-424 Low)	Experimental	Not described Receives: Drug: MP-424 (L), PEG-IFN-a-2b, RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax (Maximum Observed Concentration in Plasma) of MP-424
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Measured: Data were collected at Day1 to Day85
Tmax (Time of Maximum Concentration in Plasma) of MP-424
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Measured: Data were collected at Day1 to Day85
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Measured: Data were collected at Day1 to Day85
Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Measured: Data were collected at Day1 to Day85
T1/2(Time of Half-Life) of MP-424
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.
Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Measured: Data were collected at Day1 to Day85

Secondary outcomes (1)

Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL.
Measured: 37 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Mar 2009

First posted6 Mar 2008 (estimated)
Study startApr 2008
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00630058
Sponsor's protocol ID: G060-A5
Status last verified: Dec 2025
First submitted: 24 Feb 2008
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Suzuki F, Suzuki Y, Sezaki H, Akuta N, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Mineta R, Watahiki S, Kobayashi M, Nakayasu Y, Tsuda H, Aoki K, Yamada I, Kumada H. Exploratory study on telaprevir given every 8 h at 500 mg or 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients. Hepatol Res. 2013 Jul;43(7):691-701. doi: 10.1111/hepr.12009. Epub 2012 Nov 29.
PubMed 23190247

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-Label, Two-Arm Study of MP-424 in Combination With Peginterferon Alfa 2b and Ribavirin in Patients With Genotype 1b Hepatitis C
ClinicalTrials.gov ID: NCT00630058
Acronym / sponsor ID: G060-A5
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C, Protease Inhibitor, Telaprevir
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Collaborators: Vertex Pharmaceuticals Incorporated
Study start: Apr 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 6 Mar 2008 (estimated)
Results: Posted 18 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A (MP-424 High)	Experimental	Drug: MP-424(H), PEG-IFN-a-2b, RBV
Group B (MP-424 Low)	Experimental	Drug: MP-424 (L), PEG-IFN-a-2b, RBV

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients diagnosed with genotype 1b chronic hepatitis C

Key exclusion criteria (2 listed)

Patients diagnosed with decompensated cirrhosis
Patients diagnosed with positive HBs antigen in the test

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MP-424(H), PEG-IFN-a-2b, RBVAlso: TelaprevirMP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks	Drug	Group A (MP-424 High)
MP-424 (L), PEG-IFN-a-2b, RBVAlso: TelaprevirMP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks	Drug	Group B (MP-424 Low)

Primary outcome

Cmax (Maximum Observed Concentration in Plasma) of MP-424
Time frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Tmax (Time of Maximum Concentration in Plasma) of MP-424
Time frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Time frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Time frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
T1/2(Time of Half-Life) of MP-424
Time frame: Data were collected at Day1 to Day85
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

1 secondary outcome

Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Time frame: 37 weeks

Results and safety

Results posted to the registry on 18 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A (MP-424 High)	10	6
Group B (MP-424 Low)	10	6

Primary outcome: Cmax (Maximum Observed Concentration in Plasma) of MP-424

Time frame: Data were collected at Day1 to Day85. Mean (Standard Deviation). Unit: μg/mL

Measure	Group A (MP-424 High) n = 10	Group B (MP-424 Low) n = 10
Day 1 (Group A,B:10 cases)	1.62 (0.43)	1.45 (0.83)
Day 14 (Group A,B:10 cases)	3.96 (1.10)	3.06 (0.90)
Day 85 (Group A: 6 cases, Group B: 7 cases)	3.67 (0.87)	3.16 (1.10)

Primary outcome: Tmax (Time of Maximum Concentration in Plasma) of MP-424

Time frame: Data were collected at Day1 to Day85. Median (Full Range). Unit: hours

Measure	Group A (MP-424 High) n = 10	Group B (MP-424 Low) n = 10
Day 1 (Group A, B:10 cases)	2.51 (2.25 to 6.00)	2.54 (2.33 to 8.02)
Day 14 (Group A, B:10 cases)	2.50 (2.42 to 5.75)	2.45 (2.33 to 6.00)
Day 85 (Group A: 6 cases, Group B: 7 cases)	3.24 (2.35 to 7.75)	2.43 (2.33 to 4.00)

Primary outcome: AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424

Time frame: Data were collected at Day1 to Day85. Mean (Standard Deviation). Unit: μg/mL

Measure	Group A (MP-424 High) n = 10	Group B (MP-424 Low) n = 10
Day 1 (Group A, B: 10 cases)	7.53 (1.93)	6.55 (3.73)
Day 14 (Group A: 9 cases, Group B: 10 cases)	26.00 (6.77)	19.94 (5.97)
Day 85 (Group A: 6 cases, Group B: 7 cases)	25.00 (5.23)	21.35 (6.88)

Primary outcome: Ctrough (Minimum Observed Concentration in Plasma) of MP-424

Time frame: Data were collected at Day1 to Day85. Mean (Standard Deviation). Unit: μg/mL

Measure	Group A (MP-424 High) n = 10	Group B (MP-424 Low) n = 10
Day1 (Group A,B: 10 cases)	0.846 (0.500)	0.681 (0.412)
Day14 (Group A: 9 cases, Group B:10cases)	2.639 (0.556)	1.914 (0.717)
Day85 (Group A: 6 cases, Group B:7cases)	2.679 (0.355)	2.105 (0.819)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A (MP-424 High)	2 of 10 (20%)	10 of 10 (100%)	Not reported
Group B (MP-424 Low)	2 of 10 (20%)	10 of 10 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23190247Suzuki F, Suzuki Y, Sezaki H, Akuta N, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Mineta R, Watahiki S, Kobayashi M, Nakayasu Y, Tsuda H, Aoki K, Yamada I, Kumada H. Exploratory study on telaprevir given every 8 h at 500 mg or 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients. Hepatol Res. 2013 Jul;43(7):691-701. doi: 10.1111/hepr.12009. Epub 2012 Nov 29.

Related trials for Hepatitis C

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fumitaka Suzuki, MD principal investigator

Department of Hepatology, Toranomon Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MP-424(H), PEG-IFN-a-2b, RBV and MP-424 (L), PEG-IFN-a-2b, RBV in people with Hepatitis C, run by Tanabe Pharma Corporation at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (Maximum Observed Concentration in Plasma) of MP-424 (time frame: Data were collected at Day1 to Day85). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00630058, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.