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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003988
Receipt No. R000004803
Scientific Title Effect of pegylated interferon and ribavirin therapy on the QOL in the treatment of chronic hepatitis C
Date of disclosure of the study information 2010/08/10
Last modified on 2013/12/17

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Basic information
Public title Effect of pegylated interferon and ribavirin therapy on the QOL in the treatment of chronic hepatitis C
Acronym TOPIQS study
Scientific Title Effect of pegylated interferon and ribavirin therapy on the QOL in the treatment of chronic hepatitis C
Scientific Title:Acronym TOPIQS study
Region
Japan

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

Objectives
Narrative objectives1 To clarify whether concomitant use of COX-2 inhibitor would relieve the decrease in the QOL of the patients receiving pegylated interferon and ribavirin therapy for chronic hepatitis C.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SF-36 score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pegintron/rebetol
Interventions/Control_2 Pegintron/rebetol with celecoxib
Interventions/Control_3 Pegasys/copegas
Interventions/Control_4 Pegasys/copegas with celecoxib
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients infected with genotype 1
2. Patients with serum HCV-RNA level of 5 LogIU/mL or more.
3. Neutrophil count >= 1500/mm3
4. Platelet count >= 100000/mm3
5. Hemoglobin concentration >= 12 g/dl
Key exclusion criteria 1. Patients who were previously treated with pegylated interferon and ribavirin therapy.
2. Patients who are pregnant or lactating.
3. Patients who cannot use birth control until 6 months pass after the end of treatment.
4. Patients who have hypersensitivity to interferons or ribavirin.
5. Patients who have uncontrolled heart diseases.
6. Patients with abnormal hemoglobin diseases.
7. Patients with chronic renal failure.
8. Patients with severe depression.
9. Patients with severe liver diseases.
10. Patients with autoimmune disorders.
11. Patients receiving other antiviral drugs, immunomodulating drugs, or Sho-Sai-Ko-To.
12. Patients who have hypersensitivity to aspirin or NSAID.
13. Patients who have peptic ulcers.
14. Patients who have asthma induced by aspirin or NSAID.
15. Patients who received antiviral therapy within 6 months.
16. Patients who have a history of interstitial pneumonia.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatehiro Kagawa
Organization Tokai University School of Medicine
Division name Department of Internal Medicine, Division of Gastroenterology
Zip code
Address Shimokasuya 143, Isehara
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokai University School of Medicine
Division name Department of Internal Medicine, Division of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email kagawa@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine, Department of Internal Medicine, Division of Gastroenterology
Institute
Department

Funding Source
Organization Tokai University School of Medicine, Department of Internal Medicine, Division of Gastroenterology
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
Email

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)、池上総合病院(東京都)、平塚市民病院(神奈川県)、海老名総合病院(神奈川県)、秦野赤十字病院(神奈川県)、茅ヶ崎市立病院(神奈川県)、東名厚木病院(神奈川県)、野村消化器内科(神奈川県)、山近記念総合病院(神奈川県)、湯河原厚生年金病院(神奈川県)、伊勢原協同病院(神奈川県)、北里大学東病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 10 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 Terminated
Date of protocol fixation
2010 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 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
2010 Year 08 Month 03 Day
Last modified on
2013 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004803

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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