Clinical trial NCT01753570: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C(CHC)
Keywords: Feron
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Toray Industries, Inc
First posted: 2012-12-20
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
timeFrame: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)
Secondary outcomes:
measure: Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
timeFrame: 4 weeks
measure: Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
timeFrame: 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)
measure: Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
timeFrame: 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta)
measure: Transition of Serum HCV RNA Levels
timeFrame: Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks
measure: Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.
timeFrame: From baseline to 24 weeks after completion of drug administration
Other outcomes:
Locations:
city: Kawasaki City
country: Japan
facility: Toranomon Hospital
state: Takatsu-ku
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.