UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003988 |
|---|---|
| Receipt number | 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 15:53:50 |
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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
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
kagawa@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine, Department of Internal Medicine, Division of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004803
