UMIN-CTR Clinical Trial

Public title

Multicenter, open-label, non-controlled trial of short-term high dose dexamethasone therapy as initial treatment for idiopathic thrombocytopenic purpura

Acronym

NHOH-ITP-15

Scientific Title

Multicenter, open-label, non-controlled trial of short-term high dose dexamethasone therapy as initial treatment for idiopathic thrombocytopenic purpura

Scientific Title:Acronym

NHOH-ITP-15

Region

Japan

Condition

Idiopathic Thrombocytopenic Purpura

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In cases from 18-year-old 80-year-old of idiopathic thrombocytopenia, for patients whose platelet count less than 20,000 /mm^3 or less than 50,000 /mm^3 with bleeding symptoms, underwent short-term high dose dexamethasone therapy, its efficacy and safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Complete and partial response rate at 180 days from finish up dexamethasone pulse therapy.

Key secondary outcomes

Platelet count at 46+180 days.
Relapse free survival
Adverse event occurrence rate.
H,pyroli infection rate.
Therapeutic effect by eradication of H.pyroli.
Relapse free survival rate at 46+180days with or without H.pyroli infection.
Adverse event occurrence rate with or without eradication of H.pyroli.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Multicenter, single-arm, open-label trial

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)age >18, <80
2)newly diagnosed untreated ITP adult patients
3)Platelet count<20*10^9/L
4)Platelet count>20*10^9/L and <50*10^9/L plus bleeding symptom.
5)PS 0 to 2
6)Patients received a fully described on the basis of informed consent document, by the free will of the person that consent is obtained in writing with respect to participation in the study.
In the case of minors, it is acceptable in the approval of the guardian

Key exclusion criteria

1)Active malignancy at time of study entry
2)Concomitant treatment with anti-platelet and or anti-coagulant drugs
3)Concomitant severe psychiatric disorders
4)Women who are pregnant or breastfeeding
5)Cardiovascular diseases requiring treatment
6)Severe non-controlled, despite therapy, hypertension and diabetes
7)Liver and kidney function impairment (creatinine, ALT, AST >2 times upper normal limit)
8)HCVAb, HIVAb, HBsAg seropositive status
9)Chronic liver disease
10)Documented viral illness by the positivity of IgM, or vaccination both occurred one month before diagnosis
11)Intake of drugs not previously taken within one week before diagnosis
12) Active gastric ulcer.
13)Severe intracranial bleeding or GI bleeding
14)Presence of autoimmune hemolytic anemia
15) Continuous administration of steroid hormone or immunosuppressive agents for other disease.
16)Not appropriate for this study

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Ken Takase

Organization

NATIONAL KYUSHU MEDICAL CENTER

Division name

Hematology

Zip code

Address

1-8-1,Jigyohama,Chuo-ku, Fukuoka-shi

TEL

092-852-0700

Email

takase-k@kyumed.jp

Name of contact person

1st name
Middle name
Last name	Mari Egawa

Organization

NATIONAL KYUSHU MEDICAL CENTER

Division name

Hematology

Zip code

Address

1-8-1,Jigyohama,Chuo-ku, Fukuoka-shi

TEL

092-852-0700

Homepage URL

Email

mari@kyumed.jp

Institute

NATIONAL KYUSHU MEDICAL CENTER

Institute

Department

Personal name

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

06

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

02

Month

04

Day

Date of IRB

Anticipated trial start date

2016

Year

07

Month

01

Day

Last follow-up date

2020

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

05

Month

23

Day

Last modified on

2017

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025733