UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000020179
Receipt No. R000022112
Scientific Title Pilot study of pegylated interferon alpha 2a add on therapy in chronic hepatitis B patients under tenofovir administration
Date of disclosure of the study information 2015/12/15
Last modified on 2020/07/31 (Ver. 10)

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Basic information
Public title Pilot study of pegylated interferon alpha 2a add on therapy in chronic hepatitis B patients under tenofovir administration
Acronym Peg-IFN add on therapy to tenofovir
Scientific Title Pilot study of pegylated interferon alpha 2a add on therapy in chronic hepatitis B patients under tenofovir administration
Scientific Title:Acronym Peg-IFN add on therapy to tenofovir
Region
Japan

Condition
Condition chronic hepatitis B
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify virological and clinical efficacy of pegylated interferon alpha 2a add on therapy in chronic hepatitis B patients who are under tenofovir administration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Decline of HBs antigen amount at completing pegylated interferon alpha 2a administration, and at 24 and 48 weeks after completing it
Key secondary outcomes Factors which may be associated with rapid decline of HBs antigen amount such as clinical backgrounds, amounts of cytokines, and genetic backgrounds.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Add on pegylated-interferon alpha-2a (180 micro-g/dose) for 48 weeks in patients with chronic hepatitis B who are continuously treated with tenofovir.
Interventions/Control_2 Follow-up chronic hepatitis B patients without intervention who are continuously treated with tenofovir.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with chronic hepatitis B who are treated with tenofovir for at least 12 weeks before starting pegylated-interferon add on therapy.
2) HBV DNA in serum is negative or only signal positive at starting pegylated-interferon add on therapy.
3) Amount of HBs antigen in serum is equal to or higher than 800 IU/ml.
4) Patients whose written informed consent can be obtained as a result of full explanation of the present study.
Key exclusion criteria 1) Patients who have liver cirrhosis or hepatic failure.
2) Patients who have a complication of hepatocellular carcinoma or those who have a past history of it.
3) Patients with liver diseases which may affect clinical course of hepatitis B such as auoimmune hepatitis and alcoholic liver diseases.
4) Patients who have severe dysfunctions of organs other than the liver such as renal dysfunction and heart failure.
5) Patients who have a contraindication for pegylated interferon alha-2a in those who are assigned to pegylated-interferon add on therapy group.
6) Patients who are judged to be not eligible for the present study by corresponding physicians.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Tanaka
Organization Shinshu University
Division name School of Medicine
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto 390-8621, Japan
TEL 0263-37-2634
Email etanaka@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Tanaka
Organization Shinshu University
Division name School of Medicine
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto 390-8621, Japan
TEL 0263-37-2634
Homepage URL
Email amatsumo@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Center for Clinical Research at Shinshu University Hospital
Address Asahi 3-1-1, Matsumoto 390-8621, Japan
Tel 0263373389
Email chiken@shinshu-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 信州大学（長野県）、名古屋市立大学（愛知県）、大阪大学（大阪府）、虎の門病院（東京都）、国立病院機構長崎医療センター（大村市）、兵庫医科大学（兵庫県）、
広島大学（広島県）、千葉大学大学（千葉県）、手稲渓仁会病院（北海道）、武蔵野赤十字病院（東京都）、大阪市立大学（大阪府）、聖マリアンナ医科大学（神奈川県）、大阪医科大学（大阪府）、東海大学（神奈川県）、岡山大学（岡山県）、川崎医科大学（岡山県）、山形大学（山形県）、横浜市立大学（神奈川県）、くまもと森都総合病院（熊本県）、熊本大学（熊本県）、福岡大学（福岡県）、山梨大学（山梨県）、香川県立中央病院（香川県）、東北大学（宮城県）、国立国際医療センター（千葉県）、大阪労災病院（大阪府）、愛知医科大学（愛知県）、香川大学（香川県）

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 15 Day

Related information
URL releasing protocol https://doi.org/10.1007/s00535-020-01707-6
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1007/s00535-020-01707-6
Number of participants that the trial has enrolled 83
Results 
A prospective study of TDF and P-IFN add-on therapy was conducted. Patients with chronic hepatitis B receiving TDF therapy were divided into two arms. P-IFN was added for 48 weeks in the add-on arm (n = 32), while TDF monotherapy was maintained in the control arm (n = 51). At 96 weeks after baseline, 41% of patients in the add-on arm had shown a rapid decrease in HBsAg, versus 2% in the control arm (P < 0.001).
Results date posted
2020 Year 07 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Patients with chronic hepatitis B
Participant flow 
Registered from 20 institutions in Japan
Adverse events 
Neutropenia in 3, depression in 1, eczema in 1, Bone fracture in 1, renal dysfunction in 1
Outcome measures 
Rapid decrease of HBs antigen amount
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 12 Month 10 Day
Date of IRB
2015 Year 09 Month 08 Day
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 13 Day
Last modified on
2020 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022112