UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015230
Receipt number R000001203
Scientific Title Open-label, randomized, controlled study evaluating dose-escalation of peginterferon alpa-2b plus ribavirin in aged patients with chronic hepatitis C
Date of disclosure of the study information 2014/10/01
Last modified on 2015/06/26 22:29:28

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Basic information

Public title

Open-label, randomized, controlled study evaluating dose-escalation of peginterferon alpa-2b plus ribavirin in aged patients with chronic hepatitis C

Acronym

Randomized study evaluating dose-escalation of combination therapy in aged patients with chronic hepatitis C

Scientific Title

Open-label, randomized, controlled study evaluating dose-escalation of peginterferon alpa-2b plus ribavirin in aged patients with chronic hepatitis C

Scientific Title:Acronym

Randomized study evaluating dose-escalation of combination therapy in aged patients with chronic hepatitis C

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 compare efficacy and safety of peginterferon alpha-2b plus ribavirin by standard versus reduced dosing of peginterferon administered with ribavirin dose-escalation manner in aged patients with chronic hepatitis C

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of negative results of qualitative HCV RNA test (end-of-treatment and 24 weeks after terminating therapy

Key secondary outcomes

1. Sustained virological response rate according to the time point of viral disappearance
2. Rate of anemia (defined as hemoglobin concentration < 10 g/dL) at every week up to week 8 and every 4 weeks thereafter
3. Incidence of dose modification and discontinuation of therapy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Standard starting dose of peginterferon alpha-2b (pegintron) in combination with lower starting dose of ribavirin (Rebetol) by 200 mg, followed by dose-escalation of ribavirin by 100 mg, when hemoglobin concentration maintained at or above 12 g/dL at week 4 an 8.

Interventions/Control_2

Lower stating dose of peginterferon alpha-2b (pegintron) in combination with lower starting dose of ribavirin (Rebetol) by 200 mg, followed by dose-escalation of ribavirin by 100 mg, when hemoglobin concentration maintained at or above 12 g/dL at week 4 an 8.

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. HCV genotype 1 an HCV RNA level 100,000 IU/mL or more.
2. Cirrhosis has been excluded by histological data, image diagnosis, and laboratory tests.
3. Complication with hepatocellular carcinoma has been ruled out.



Key exclusion criteria

1. Hemoglobin values at entry visit less than 12 g/dL.
2. Allergic to interferon or vaccine preparations.
3. Allergic to ribavirin or other nucleos(t)ide 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. Neurologic or psychiatric disease.
9. Sever or decompensated liver disease.
10. Hypertension or diabetes.
11. History of apoplexy.
12. Autoimmune hepatitis.
13. Chronic hepatitis B or excessive daily intake of alcohol
14. Concomitant immunosuppressive or herbal medication such as Sho-saiko-to.
15. Other conditions considered inappropriate by attending physician.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiaki Iwasaki

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-5-1, Kita-ku, Shikata-cho, Okayama-city, Okayama, Japan

TEL

086-235-7219

Email

yiwasaki@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiaki Iwasaki

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-5-1, Kita-ku, Shikata-cho, Okayama-city, Okayama, Japan

TEL

086-235-7219

Homepage URL


Email

yiwasaki@cc.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

Not applicable

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

2014 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://onlinelibrary.wiley.com/doi/10.1002/jmv.24276/abstract

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

2005 Year 11 Month 05 Day

Date of IRB


Anticipated trial start date

2006 Year 01 Month 01 Day

Last follow-up date

2012 Year 06 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

2014 Year 09 Month 23 Day

Last modified on

2015 Year 06 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001203


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name