Chronic Hepatitis C(CHC)Phase 3NCT01753570
Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)
A Phase 3 study testing MP-424, RBV(24 weeks) and IFN beta(24 weeks) 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 IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Hepatitis C(CHC)
- What is being tested?
- MP-424, RBV(24 weeks) and IFN beta(24 weeks)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2012to Oct 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
- Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based 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 antibodies-positive
- History of, or concurrent hepatocellular carcinoma
- History of, or concurrent serious 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 IFN Beta and RBV, in Subjects With Genotype 1/2 Hepatitis C, Who Are Treatment-Naïve or Have Received Interferon Based Therapy
This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.
- Conditions
- Chronic Hepatitis C(CHC)
- Being tested
- MP-424, RBV(24 weeks), IFN beta(24 weeks), RBV(48 weeks), IFN beta(48 weeks)
- Keywords
- Feron
- 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
RBV(24 weeks)Drug
RBV: 600 - 1000mg/day based on body weight for 24 weeks
IFN beta(24 weeks)Drug
IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks
RBV(48 weeks)Drug
RBV: 600 - 1000mg/day based on body weight for 48 weeks
IFN beta(48 weeks)Drug
IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| MP-424+RBV+IFN beta, Genotype1 | Experimental | Not described Receives: Drug: MP-424; Drug: RBV(24 weeks); Drug: IFN beta(24 weeks) |
| RBV+IFN beta, Genotype1 | Experimental | Not described Receives: Drug: RBV(48 weeks); Drug: IFN beta(48 weeks) |
| MP-424+RBV+IFN beta, Genotype2 | Experimental | Not described Receives: Drug: MP-424; Drug: RBV(24 weeks); Drug: IFN beta(24 weeks) |
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: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)
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: 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Measured: 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta)
Transition of Serum HCV RNA Levels
Measured: Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks
Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
To examine the emergence of resistance-associated variants after MP-424 administration.
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 completionOct 2015
- Study completionOct 2015
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Toray Industries, Inc
- Responsible party
- Sponsor
- Investigators
- Kazuoki Kondo, M.D., Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753570
- Sponsor's protocol ID
- G060-F1
- 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, Mochida S, Nakamuta M, Suzuki F, Yagi T, Takasaki R, Okai M, Kamiya N, Okada Y, Hirota S, Orihashi M, Ochi M, Chayama K. Efficacy and safety of telaprevir with natural human interferon-beta and ribavirin in Japanese chronic hepatitis C patients with depression. Hepatol Res. 2018 Feb;48(2):184-192. doi: 10.1111/hepr.12914. Epub 2017 Jul 19.
PubMed 28497489
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 IFN Beta and RBV, in Subjects With Genotype 1/2 Hepatitis C, Who Are Treatment-Naïve or Have Received Interferon Based Therapy
- ClinicalTrials.gov ID
- NCT01753570
- Acronym / sponsor ID
- G060-F1
- Conditions
- Chronic Hepatitis C(CHC)
- Keywords
- Feron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Toray Industries, Inc
- Study start
- Dec 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Posted 26 Oct 2018
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 IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MP-424+RBV+IFN beta, Genotype1 | Experimental | Drug: MP-424, Drug: RBV(24 weeks), Drug: IFN beta(24 weeks) |
| RBV+IFN beta, Genotype1 | Experimental | Drug: RBV(48 weeks), Drug: IFN beta(48 weeks) |
| MP-424+RBV+IFN beta, Genotype2 | Experimental | Drug: MP-424, Drug: RBV(24 weeks), Drug: IFN beta(24 weeks) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
- Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based 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 antibodies-positive
- History of, or concurrent hepatocellular carcinoma
- History of, or concurrent serious 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 | MP-424+RBV+IFN beta, Genotype1, MP-424+RBV+IFN beta, Genotype2 |
| RBV(24 weeks)RBV: 600 - 1000mg/day based on body weight for 24 weeks | Drug | MP-424+RBV+IFN beta, Genotype1, MP-424+RBV+IFN beta, Genotype2 |
| IFN beta(24 weeks)IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks | Drug | MP-424+RBV+IFN beta, Genotype1, MP-424+RBV+IFN beta, Genotype2 |
| RBV(48 weeks)RBV: 600 - 1000mg/day based on body weight for 48 weeks | Drug | RBV+IFN beta, Genotype1 |
| IFN beta(48 weeks)IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks | Drug | RBV+IFN beta, Genotype1 |
Primary outcome
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Time frame: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)
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: 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Time frame: 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta)
Transition of Serum HCV RNA Levels
Time frame: Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks
Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
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 28497489Kumada H, Mochida S, Nakamuta M, Suzuki F, Yagi T, Takasaki R, Okai M, Kamiya N, Okada Y, Hirota S, Orihashi M, Ochi M, Chayama K. Efficacy and safety of telaprevir with natural human interferon-beta and ribavirin in Japanese chronic hepatitis C patients with depression. Hepatol Res. 2018 Feb;48(2):184-192. doi: 10.1111/hepr.12914. Epub 2017 Jul 19.
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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(24 weeks) and IFN beta(24 weeks) 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 26 Oct 2018). 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: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)). 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 NCT01753570, 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.