UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003131 |
|---|---|
| Receipt number | R000003795 |
| Scientific Title | A Phase-I/II Trial of Oral Hydroxyurea in Chronic Hepatitis C Patients |
| Date of disclosure of the study information | 2010/02/05 |
| Last modified on | 2013/04/02 15:17:59 |
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Basic information
Public title
A Phase-I/II Trial of Oral Hydroxyurea in Chronic Hepatitis C Patients
Acronym
A Phase-I/II Trial of Oral Hydroxyurea in Chronic Hepatitis C Patients
Scientific Title
A Phase-I/II Trial of Oral Hydroxyurea in Chronic Hepatitis C Patients
Scientific Title:Acronym
A Phase-I/II Trial of Oral Hydroxyurea in Chronic Hepatitis C Patients
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that HU suppresses HCV replication in human.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
PhaseI:The safety
PhseII:Antiviral effect
Key secondary outcomes
PhaseI:Antiviral effect
PhaseII: The safety, ALT change
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Phase I: dosage of each levels
Level1:Hydrea capsule 1500mg/day
Level2:Hydrea capsule 1000mg/day
Level3:Hydrea capsule 500mg/day
PhaseII: RD decided in Phase I trial
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic hepatitis C patients
HBs Ag negative
HCV RNA> 5LogIU/ML
Neutrophils: >1,500/uL
Platelets: >70,000/uL
Hemoglobin: >10g/dL
BW: >40kg
Patients with Informed consent
Key exclusion criteria
Pregnant Women
Patients with Severe heart disease
Patients with Severe DM, HT
Patients without selectable factors
Target sample size
20
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
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 消化器病センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 05 | 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
Recommended dose (RD) was decided
as 1500mg/day.
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
| 2008 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 02 | Day |
Last modified on
| 2013 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003795
