UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open-label single arm study to evaluate the safety and efficacy of 12-week simeprevir/peginterferon alpha-2a/ribavirin treatment in patients with chronic genotype 1 HCV infection
Title of the study (Brief title)	A study of 12-week simeprevir/peginterferon alpha-2a/ribavirin treatment for chronic genotype 1 HCV infection (LINK study)
Region	Japan

Condition
Condition	chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy, tolerability, and safety of 12-week simeprevir/peginterferon alfa-2a/ribavirin treatment in patients with chronic genotype 1 HCV infection who are untreated or relapsed after previous therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The percentage of patients with a sustained virologic response 12 weeks after planned end of treatment (SVR12)
Key secondary outcomes	1. The percentage of patients with a sustained virologic response 24 weeks after planned end of treatment (SVR24). 2. The percentage of patients whose serum HCV-RNA is undetectable at weeks 2, 4, 8, 12, 24, 36, and 48. 3. The percentage of relapsers. 4. The percentage of patients with breakthrough. 5. The percentage of patients who meet stopping criteria. 6. The percentage of patients who have adverse effects. 7. Relationship between IL-28B SNP and efficacy. 8. Relationship between HCV core 70 variants and efficacy. 9. Relationship between SNPs of SLCO1B1 and SLCO1B3, and simeprevir-induced hyperbilirubinemia. 10. Analysis of HCV variants resistant to simeprevir in breakthrough cases.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	simeprevir, pegylated interferon alfa-2a, ribavirin Patients will receive 12-week simeprevir/peginterferon alfa-2a/ribavirin treatment. If serum HCV-RNA is undetectable at weeks 2, 4 and 8, all treatment will be stopped. In other cases, patients will receive peginterferon alfa-2a/ribavirin treatment for additional 12 weeks (totally 24 weeks) unless they meet protocol-defined stopping criteria (decrease of HCV-RNA levels smaller than 2 logIU/mL at week 12, or breakthrough).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Infected with genotype 1 (1a or 1b) HCV 2. Serum HCV-RNA levels greater than 5 logIU/mL 3. Untreated or relapsed after treatment of (peg)interferon with or without ribavirin 4. WBC count of 3000/microL or higher, neutrophil count of 1500/microL or higher, platelet count of 90000/microL or higher, and hemoglobin count of 12 g/dl or higher within 30 days prior to entry into the study
Key exclusion criteria	1. patients who received treatments containing telaprevir 2. pregnant women 3. patients allergic to ribavirin or IFN 4. patients with uncontrolled heart diseases 5. patients with abnormal hemoglobin 6. patients with chronic renal diseases 7. patients with severe depression or mental illness 8. patients with liver cirrhosis or liver failure 9. patients who cannot discontinue other antiviral or immunomodulating drugs
Target sample size	160

Research contact person
Name of lead principal investigator	Tatehiro Kagawa
Organization	Tokai University School of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	Shimokasuya 143, Isehara
TEL	81-463-93-1121
Email	kagawa@tokai.ac.jp

Public contact
Name of contact person	Tatehiro Kagawa
Organization	Tokai University School of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	Shimokasuya 143, Isehara
TEL	81-463-93-1121
Homepage URL
Email	kagawa@tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東海大学医学部付属病院（神奈川県）、東海大学医学部付属大磯病院（神奈川県）、東海大学医学部付属東京病院（東京都）、東海大学医学部付属八王子病院（東京都）、横浜市立大学病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）、北里大学東病院（神奈川県）、聖マリアンナ医科大学病院（神奈川県）、川崎市立多摩病院（神奈川県）、聖マリアンナ医科大学横浜市西部病院（神奈川県）、海老名総合病院（神奈川県）、伊勢原協同病院（神奈川県）、東名厚木病院（神奈川県）、秦野赤十字病院（神奈川県）、平塚市民病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 20 Day
Anticipated trial start date	2013 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 24 Day
Last modified on	2016 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014741