UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003457 |
|---|---|
| Receipt number | R000004186 |
| Scientific Title | Phase I/II trial of oral hydroxyurea in combination with pegylated interferon and ribavirin in chronic hepatitis C patients |
| Date of disclosure of the study information | 2010/04/09 |
| Last modified on | 2013/04/24 09:26:18 |
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Basic information
Public title
Phase I/II trial of oral hydroxyurea in combination with pegylated interferon and ribavirin in chronic hepatitis C patients
Acronym
Phase I/II trial of oral hydroxyurea in combination with pegylated interferon and ribavirin in chronic hepatitis C patients
Scientific Title
Phase I/II trial of oral hydroxyurea in combination with pegylated interferon and ribavirin in chronic hepatitis C patients
Scientific Title:Acronym
Phase I/II trial of oral hydroxyurea in combination with pegylated interferon and ribavirin 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 investigate the safety and effectiveness of oral hydroxyurea in combination with pegylated interferon and ribavirin in chronic hepatitis C patients.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard therapy is performed for 48 weeks with pegylated IFN alpha-2b+ribavirin. Further, hydroxyurea is administered in combination as follows.
Phase I trial: each levels of HU is
orally administered for 12-24 weeks.
Phase II trial: HU of recommended dose (RD) determined by phase I trial is administered for 12-24 weeks.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age>=50 to <80years
Chronic hepatitis C patients
HBs Ag negative
HCV RNA>= 5LogIU/mL
Neutrophils: >=1,500/uL
Platelets: >=80,000/uL
Hemoglobin: >=10g/dL
BW: >=40kg
Patients with Informed consent
Key exclusion criteria
1)Pregnant or lactating Women
2)Patients with uncontrolled heart disease
3)Patients with uncontorolled DM or HT
4)Patients with inadequate haematological status
5) Patients with exclusion criteria for PEG/RBV therapy
6) Patient with decision of exclusion
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
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
Homepage URL
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）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | 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 | 04 | Month | 07 | Day |
Last modified on
| 2013 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004186
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
