UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020340
Receipt number R000023495
Scientific Title A multicenter, investigator-initiated phase II clinical trial involving administration of a cross-linked gelatin hydrogel containing recombinant human basic fibroblast growth factor (rh-bFGF) to prevent the collapse of the femoral head
Date of disclosure of the study information 2015/12/25
Last modified on 2019/01/07 16:31:05

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Basic information

Public title

A multicenter, investigator-initiated phase II clinical trial involving administration of a cross-linked gelatin hydrogel containing recombinant human basic fibroblast growth factor (rh-bFGF) to prevent the collapse of the femoral head

Acronym

A clinical trial for idiopathic osteonecrosis of femoral head using trafermin (genetical recombination) gelatin hydrogel to evaluate the effectiveness and the safety (TRION)

Scientific Title

A multicenter, investigator-initiated phase II clinical trial involving administration of a cross-linked gelatin hydrogel containing recombinant human basic fibroblast growth factor (rh-bFGF) to prevent the collapse of the femoral head

Scientific Title:Acronym

A clinical trial for idiopathic osteonecrosis of femoral head using trafermin (genetical recombination) gelatin hydrogel to evaluate the effectiveness and the safety (TRION)

Region

Japan


Condition

Condition

Osteonecrosis of the femoral head

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safety of administering, via a minimally invasive procedure, a cross-linked gelatin hydrogel (denoted here simply as a "gelatin hydrogel") containing genetical recombinant trafermin (rh-bFGF) in the femoral head in patients with idiopathic osteonecrosis of the femoral head. To observe the natural history of osteonecrosis of the femoral head in patients and to use these patients as a control group to compare the efficacy of the gelatin hydrogel containing trafermin.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

The rate of collapse of the femoral head 24 months after administration of the investigational agent

Key secondary outcomes

1.Changes in collapse of the femoral head over time
2.The stage of osteonecrosis of the femoral head over time
3.The type of osteonecrosis of the femoral head over time
4.Assessment of bone regeneration
5.Changes in the Harris Hip Score over time
6.Changes in the UCLA Activity Score over time
7.Incidence of AEs and adverse reactions


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Gelatin hydrogel containing 800 ug of trafermin (genetical recombination)

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



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Osteonecrosis of the femoral head meets the diagnostic criteria for that condition and is Stage 1 or Stage 2.
2) Osteonecrosis of the femoral head is Type C1 or C2 depending on the location of necrosis.
3) A gelatin hydrogel can be administered to the necrotic region in the affected femur (guide pins are able to reach the necrotic portion of the femoral head).
4) Patients are ages 15 to 75 when they consent to participate in this trial.
5) The patient is able to provide consent to participate in this trial in writing. If the patient is a minor, the consent of the patient and his/her representative (guardian) is required.

Key exclusion criteria

1) Preoperatively, a plain CT scan of the hip reveals cracks in subchondral bone in the femoral head or disruption of the continuity of the femoral head and neck.
2) Patients with a tumor or tumor-like condition, epiphyseal dysplasia, trauma (e.g. femoral neck fracture or traumatic dislocation of the hip), or slipped capital femoral epiphysis, patients receiving pelvic radiation, patients with decompression sickness and osteonecrosis of the femoral head, and patients with Perthes disease.
3) Patients who were diagnosed with osteonecrosis of the femoral head and who previously underwent this surgery.
4) Patients with a BMI of 30 or greater.
5) Patients with any of the following conditions:
*Conditions that could pose major obstacles to the conduct of this trial (poorly controlled diabetes, hypertension, severe heart disease, respiratory disease, renal failure, hepatic failure, etc.)
*Patients with a malignancy who have been disease-free for less than 5 years (However, carcinoma in situ and intramucosal carcinoma are not included in active malignancies)
*Patients with a psychiatric disorder or psychiatric symptoms that would preclude participation in this trial
*Patients with an active infection that would pose a problem clinically.
6) Patients being treated for diabetic retinopathy. (pre-proliferative diabetic retinopathy or proliferative diabetic retinopathy).
7) Patients with a previous history of any of the following:
*A gelatin allergy
*Patients with a drug allergy or other condition that would pose a problem during this trial.
8) Patients requiring continuous systemic administration of steroids (a dose exceeding an equivalent prednisolone dose of 15 mg/day).
9) Women who are or may be pregnant. Women who are nursing. Men or women who do not consent to use of contraception during this trial.
10) Other individuals whom an investigator or sub-investigator deems inappropriate for participation in this trial.

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiko Akiyama

Organization

Gifu University Hospital

Division name

Department of Orthopaedic Surgery

Zip code


Address

1-1 Yanagido, Gifu City 501-1194, Japan

TEL

058-230-6000

Email

trion_office@ml.kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yutaka Kuroda

Organization

Kyoto University Hospital

Division name

Department of Orthopaedic Surgery

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507 JAPAN

TEL

075-751-3111

Homepage URL

http://hosp.gifu-u.ac.jp/medical/seikei/tiken.html

Email

trion_office@ml.kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Haruhiko Akiyama, Gifu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


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

岐阜大学医学部附属病院(Gifu University Hospital)、京都大学医学部附属病院(Kyoto University Hospital)、東京大学医学部附属病院(The University of Tokyo Hospital)、大阪大学医学部附属病院(Osaka University Hospital)


Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 25 Day


Related information

URL releasing protocol

http://www.kuhp.kyoto-u.ac.jp/~seikeigeka/ekigaku/TRION.pdf

Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 10 Month 20 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 27 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 04 Month 30 Day

Date trial data considered complete

2019 Year 06 Month 30 Day

Date analysis concluded

2019 Year 10 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 12 Month 25 Day

Last modified on

2019 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023495


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name