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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004141
Receipt No. R000004781
Scientific Title Darbepoetin alpha for anemia in patients with chronic hepatitis C treated with combination therapy of peginterferon alpha-2b plus ribavirin
Date of disclosure of the study information 2010/09/01
Last modified on 2016/03/13

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Basic information
Public title Darbepoetin alpha for anemia in patients with chronic hepatitis C treated with combination therapy of peginterferon alpha-2b plus ribavirin
Acronym Darbepoetin for ribavirin-induced anemia in chronic hepatitis C patients
Scientific Title Darbepoetin alpha for anemia in patients with chronic hepatitis C treated with combination therapy of peginterferon alpha-2b plus ribavirin
Scientific Title:Acronym Darbepoetin for ribavirin-induced anemia 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 assess by a randomized, controlled trial the efficacy and safety of darbepoetin alpha for anemia in aged women with chronic hepatitis C treated with combination therapy of peginterferon alpha-2b plus ribavirin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence rates of negative result of qualitative HCV RNA test at 12 weeks of treatment, end of treatment, and 24 weeks after terminating therapy.
Key secondary outcomes 1) The incidence rates of dose reduction and discontinuation of ribavirin.
2) Changes in hemoglobin concentration.
3) The incidence rates of completion of the combination therapy of peginterferon alpha-2b plus ribavirin.
4) Assessment of the QOL by SF-36 ver. 2 at baseline and at 4 and 24 weeks of treatment.
5) Adverse events and their incidence rates and grade.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Darbepoetin alpha in combination with peginterferon alpha-2b plus ribavirin.
Interventions/Control_2 Peginterferon alpha-2b plus ribavirin.
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
70 years-old >
Gender Female
Key inclusion criteria 1. Chronic hepatitis C with HCV genotype 1 and high viral load (HCV RNA >= 5 Log IU/mL).
2. 50 years-old or older and youger than 70 years-old.
3. Women.
4. Hemoglobin concentration >= 12 g/dL and < 15 g/dL.
5. White blood cell count >=4,000/mm3.
6. Neutrophil count >=1,500/mm3.
7. Platelet count >=10,000/mm3.
Key exclusion criteria 1. Allergic to peginterferon alpha-2b or other interferon preparations.
2. Allergic to vaccine or biological preparations.
3. Allergic to ribavirin or other nucleoside analogue preparations.
4. Pregnant or under breast feeding.
5. Uncontrolled cardiovascular diseases.
6. Abnormal hemoglobinemia.
7. Chronic renal failure or creatinine clearance value less than 50 mL/min.
8. Severe depression or psychiatric disorders including a history of a suicide attempt.
9. Severe or decompensated liver disease.
10. Vascular diseases of central nervous system.
11. Autoimmune liver diseases.
12. Concomitant herbal medication such as Sho-saiko-to.
13. Allergic to darbepoetin alpha or other erythropoietin preparations.
14. Other conditions considered inappropriate by attending physician.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fusao Ikeda
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Molecular Hepatology
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7219
Email fikeda@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Iwasaki
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL 086-235-7219
Homepage URL
Email yiwasaki@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2010 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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 09 Month 01 Day
Last modified on
2016 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004781

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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