UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012661 |
|---|---|
| Receipt number | R000014741 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2013/12/24 |
| Last modified on | 2016/06/24 16:12:47 |
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Basic information
Public title
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
Acronym
A study of 12-week simeprevir/peginterferon alpha-2a/ribavirin treatment for chronic genotype 1 HCV infection (LINK study)
Scientific Title
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
Scientific Title:Acronym
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.
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
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
| 1st name | |
| Middle name | |
| Last name | Tatehiro Kagawa |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
Shimokasuya 143, Isehara
TEL
81-463-93-1121
kagawa@tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatehiro Kagawa |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
Shimokasuya 143, Isehara
TEL
81-463-93-1121
Homepage URL
kagawa@tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 20 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014741
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