Chronic Hepatitis C (CHC)Phase 3NCT01753557
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
A Phase 3 study testing MP-424, RBV and PEG-IFN alfa-2a in people with Chronic Hepatitis C (CHC), run by Tanabe Pharma Corporation at 1 site in Japan.
Trial summary
This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Hepatitis C (CHC)
- What is being tested?
- MP-424, RBV and PEG-IFN alfa-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2012to Nov 2014
- Phase
- Phase 3
- 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
- Genotype 1 CHC
- treatment-naïve or relapsers (patient who relapsed after previous treatment)
- Able and willing to follow contraception requirements
Who cannot join
- Cirrhosis of the liver or hepatic failure
- Hepatitis B surface antigen-positive or HIV (Human Immunodeficiency Virus) antibodies-positive
- History of, or concurrent hepatocellular carcinoma
- History of, or concurrent depression, schizophrenia, or suicide attempt in the past
- Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment
This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.
- Conditions
- Chronic Hepatitis C (CHC)
- Being tested
- MP-424, RBV, PEG-IFN alfa-2a
- Keywords
- Pegasys
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP-424Drug
MP-424: 750mg every 8 hours (q8h) for 12 weeks
RBVDrug
RBV: 600 - 1000 mg/day based on body weight for 24 weeks
PEG-IFN alfa-2aDrug
PEG-IFN alfa-2a: 180mcg/week for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Naive | Experimental | Not described Receives: Drug: MP-424; Drug: RBV; Drug: PEG-IFN alfa-2a |
| Treatment-Relapsed | Experimental | Not described Receives: Drug: MP-424; Drug: RBV; Drug: PEG-IFN alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Measured: 48 weeks
Secondary outcomes (5)
Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
Measured: 4 weeks
Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
Measured: 24 weeks
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Measured: 36 weeks
Transition of Serum HCV RNA Levels
Measured: baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)
Measured: From baseline to 24 weeks after completion of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2014
- Study completionNov 2014
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 Chronic Hepatitis C (CHC)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kazuoki Kondo, M.D., Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753557
- Sponsor's protocol ID
- G060-A12
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2012
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kumada H, Suzuki F, Kamiya N, Orihashi M, Nakayasu Y, Yamada I. Efficacy and safety of telaprevir with pegylated interferon alpha-2a and ribavirin in Japanese patients. Hepatol Res. 2017 May;47(6):514-521. doi: 10.1111/hepr.12722. Epub 2016 Jun 4.
PubMed 27062488
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 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment
- ClinicalTrials.gov ID
- NCT01753557
- Acronym / sponsor ID
- G060-A12
- Conditions
- Chronic Hepatitis C (CHC)
- Keywords
- Pegasys
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Posted 3 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-Naive | Experimental | Drug: MP-424, Drug: RBV, Drug: PEG-IFN alfa-2a |
| Treatment-Relapsed | Experimental | Drug: MP-424, Drug: RBV, Drug: PEG-IFN alfa-2a |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Genotype 1 CHC
- treatment-naïve or relapsers (patient who relapsed after previous treatment)
- Able and willing to follow contraception requirements
Key exclusion criteria (5 listed)
- Cirrhosis of the liver or hepatic failure
- Hepatitis B surface antigen-positive or HIV (Human Immunodeficiency Virus) antibodies-positive
- History of, or concurrent hepatocellular carcinoma
- History of, or concurrent depression, schizophrenia, or suicide attempt in the past
- Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
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-424MP-424: 750mg every 8 hours (q8h) for 12 weeks | Drug | Treatment-Naive, Treatment-Relapsed |
| RBVRBV: 600 - 1000 mg/day based on body weight for 24 weeks | Drug | Treatment-Naive, Treatment-Relapsed |
| PEG-IFN alfa-2aPEG-IFN alfa-2a: 180mcg/week for 24 weeks | Drug | Treatment-Naive, Treatment-Relapsed |
Primary outcome
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Time frame: 48 weeks
5 secondary outcomes
Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
Time frame: 4 weeks
Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
Time frame: 24 weeks
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Time frame: 36 weeks
Transition of Serum HCV RNA Levels
Time frame: baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)
Time frame: From baseline to 24 weeks after completion of drug administration
Results and safety
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 27062488Kumada H, Suzuki F, Kamiya N, Orihashi M, Nakayasu Y, Yamada I. Efficacy and safety of telaprevir with pegylated interferon alpha-2a and ribavirin in Japanese patients. Hepatol Res. 2017 May;47(6):514-521. doi: 10.1111/hepr.12722. Epub 2016 Jun 4.
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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.
Kazuoki Kondo, M.D. study director
Tanabe Pharma Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MP-424, RBV and PEG-IFN alfa-2a in people with Chronic Hepatitis C (CHC), 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 3 inclusion and 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Oct 2016). 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?
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) (time frame: 48 weeks). 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 NCT01753557, 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.