UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004141
Receipt number 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 2023/03/12 11:56:13

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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 Fusao
Middle name
Last name Ikeda

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Division name

Department of Molecular Hepatology

Zip code

700-8558

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 Yoshiaki
Middle name
Last name Iwasaki

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Division name

Department of Gastroenterology and Hepatology

Zip code

700-8558

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 or person

Institute

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

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

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

Address

2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan

Tel

086-235-6762

Email

mae6605@adm.okayama-u.ac.jp


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

21

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

2010 Year 07 Month 27 Day

Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2024 Year 03 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 09 Month 01 Day

Last modified on

2023 Year 03 Month 12 Day



Link to view the page

Value
https://center6.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