UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020179 |
|---|---|
| Receipt number | 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 10:41:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
amatsumo@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022112
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
