UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003247 |
|---|---|
| Receipt number | R000003926 |
| Scientific Title | Prospective randomized controlled trial to test efficacy and safety of PEG-IFN alpha-2a/Ribavirin (Copegus) plus Raloxifene hydrochloride for postmenopausal women with chronic hepatitis C.(PCR study) |
| Date of disclosure of the study information | 2010/02/26 |
| Last modified on | 2015/09/10 17:06:25 |
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Basic information
Public title
Prospective randomized controlled trial to test efficacy and safety of PEG-IFN alpha-2a/Ribavirin
(Copegus) plus Raloxifene hydrochloride for postmenopausal women with chronic hepatitis C.(PCR study)
Acronym
PCR-Study
Scientific Title
Prospective randomized controlled trial to test efficacy and safety of PEG-IFN alpha-2a/Ribavirin
(Copegus) plus Raloxifene hydrochloride for postmenopausal women with chronic hepatitis C.(PCR study)
Scientific Title:Acronym
PCR-Study
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of the addition in the effect reinforcement action and using together PEG-IFN alpha 2a/RBV by the read-in administering of Raloxifene hydrochloride.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Sustained virologic response
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A:Read-in therapy of Raloxifene hydrochloride 60mg/day for 8 weeks followed by PEG-IFN alpha 2a (90-180 microgram/weekly)+RBV+Raloxifene hydrochloride for 48-72 weeks.
Interventions/Control_2
B:PEG-IFN alpha 2a (90-180 microgram/weekly) +RBV for 48-72weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Chronic hepatitis C patients
HBs Ag negative
2.Postmenopausal women
3.Patient who meets the following criteria for laboratory tests.
HCV RNA> 5LogIU/ML
Neutrophils: >1,500/microL
Platelets: >70,000/microL
Hemoglobin: >10g/dL
BW: >40kg
Patients with Informed consent
4.Patients who have signed consent to participate in this research
Key exclusion criteria
Patient with
1.Pregnant or lacting women and women who may be pregnant
2.Premenopausal women
3.allergic to ribavirin or nucleoside analogues
4.hemoglobinopathy(thalassemia, sickle cell disease)
5.an uncontrollabl heart trouble(myocardial infarction, heart failure, or arrhythmia)
6.an poorly controlled diabetes mellitus and hypertension
7.severe renal disease, Ccr < 50ml/min
8.severe depression or psychosomatic disorders.
9.autoimmune disease or the doubt
10.clinical laboratory date does not meet selection criterion.
11.drugg allergy against interferon
12.Patient who has previous history of hypersensitivity for biological products such as vaccines
13.Patient who cannot do of prohibition of using together medicine for this treatment period
14.Patient who has deep-vein thrombosis, lung embolism, and venous thromboembolism of retina vein thrombosis etc. or patient who has the previous history.
15.Patient who is a long term and immovable.
16.Patient of antiphospholipid antibody syndrome.
17.Patient who admitted that doctor in charge is improper as object person in present study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Morimoto |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
morimoto@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akito Nozaki |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
akino@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Gastroenterological Center
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
横浜市立大学附属市民総合医療センター（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）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 26 | 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 | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 24 | Day |
Last modified on
| 2015 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003926
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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