UMIN-CTR Clinical Trial

Public title

A Phase 1/2 Study of ADR-001 in Patients with Liver Cirrhosis

Acronym

A Phase 1/2 Study of ADR-001 in Patients with Liver Cirrhosis

Scientific Title

A Phase 1/2 Study of ADR-001 in Patients with Liver Cirrhosis

Scientific Title:Acronym

A Phase 1/2 Study of ADR-001 in Patients with Liver Cirrhosis

Region

Japan

Condition

Decompensated Liver Cirrhosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This is a Phase 1/2 study in patients with liver cirrhosis caused by hepatitis C or nonalcoholic steatohepatitis. The safety and preliminary efficacy are evaluated in Phase 1, and the recommended dose for Phase 2 is determined. The exploratory efficacy and safety are investigated in Phase 2.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II

Primary outcomes

Phase 1
･Safety

Phase 2
･Improvement rate of Child-Pugh score

Key secondary outcomes

Phase 1
･Change of Child-Pugh score
･Improvement rate of Child-Pugh score
･Improvement rate of Child-Pugh grade

Phase 2
･Safety
･Change of Child-Pugh score
･Improvement rate of Child-Pugh grade

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Phase1
Single dose of ADR-001, adipose-derived mesenchymal stem cell, is administered one of 3 doses intravenously. The safety and preliminary efficacy are evaluated in Phase 1, and the recommended dose for Phase 2 is determined.

Phase2
The recommended dose of ADR-001 is administered once a week, total four times intravenously. The exploratory efficacy and safety are investigated in Phase 2.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

･Men and women >= 20 years of age
･Chronic hepatitis C or NASH
･Child-Pugh grade B liver cirrhosis
･ECOG Performance Status <= 2

Key exclusion criteria

･Liver cirrhosis patients other than hepatitis C or NASH
･Malignant neoplasm (except hepatocellular carcinoma patients without recurrence more than 2 years)
･History of venous thrombosis or pulmonary embolism
･Serum creatinine >= 2 mg/dL or T-Bil >= 5.0 mg/dL
･Infection with hepatitis B, HIV, ATLV-1 or parvovirus B19
･Patients experienced transplantation or cell therapy
･Pregnancy or positive on pregnancy test
･Complications of significant heart disease, kidney disorder, or respiratory disease
･Drug or alcohol abuse

Target sample size

27

Name of lead principal investigator

1st name	Shuji
Middle name
Last name	Terai

Organization

Niigata University Medical & Dental Hospital

Division name

Division of Gastroenterology and Hepatology

Zip code

951-8520

Address

754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata 951-8510

TEL

025-223-6161

Email

adr-001@rohto.co.jp

Name of contact person

1st name	Contact for clinical study information
Middle name
Last name	Contact for clinical study information

Organization

Rohto Pharmaceutical Co., Ltd.

Division name

Contact for clinical study information

Zip code

105-0022

Address

20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo, Japan 105-0022

TEL

03-6832-6014

Homepage URL

http://www.med.niigata-u.ac.jp/in3/medical/clinical%20LC.html

Email

adr-001@rohto.co.jp

Institute

Rohto Pharmaceutical Co., Ltd.

Institute

Department

Personal name

Organization

Rohto Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

N/A

Name of secondary funder(s)

N/A

Organization

Institutional Review Board of Niigata University Medical & Dental Hospital

Address

754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata

Tel

025-223-6161

Email

Chiken7@med.niigata-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

新潟大学医歯学総合病院（新潟県）、日本大学医学部附属板橋病院（東京都）、北里大学病院（神奈川県）、大阪大学医学部附属病院（大阪府）、近畿大学病院（大阪府）、徳島大学病院（徳島県）、山梨大学医学部附属病院（山梨県）、旭川医科大学病院（北海道）、広島大学病院（広島県）、大垣市民病院（岐阜県）、医療法人社団三成会 新百合ヶ丘総合病院（神奈川県）

Date of disclosure of the study information

2017

Year

08

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

05

Month

08

Day

Date of IRB

2007

Year

06

Month

27

Day

Anticipated trial start date

2017

Year

07

Month

20

Day

Last follow-up date

2023

Year

04

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

08

Month

03

Day

Last modified on

2023

Year

09

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032636