Unique ID issued by UMIN | UMIN000020340 |
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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 |
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
A clinical trial for idiopathic osteonecrosis of femoral head using trafermin (genetical recombination) gelatin hydrogel to evaluate the effectiveness and the safety (TRION)
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
A clinical trial for idiopathic osteonecrosis of femoral head using trafermin (genetical recombination) gelatin hydrogel to evaluate the effectiveness and the safety (TRION)
Japan |
Osteonecrosis of the femoral head
Orthopedics |
Others
NO
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.
Efficacy
Exploratory
Explanatory
Phase II
The rate of collapse of the femoral head 24 months after administration of the investigational agent
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Gelatin hydrogel containing 800 ug of trafermin (genetical recombination)
15 | years-old | <= |
75 | years-old | >= |
Male and Female
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.
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.
64
1st name | |
Middle name | |
Last name | Haruhiko Akiyama |
Gifu University Hospital
Department of Orthopaedic Surgery
1-1 Yanagido, Gifu City 501-1194, Japan
058-230-6000
trion_office@ml.kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Yutaka Kuroda |
Kyoto University Hospital
Department of Orthopaedic Surgery
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507 JAPAN
075-751-3111
http://hosp.gifu-u.ac.jp/medical/seikei/tiken.html
trion_office@ml.kuhp.kyoto-u.ac.jp
Haruhiko Akiyama, Gifu University Hospital
Japan Agency for Medical Research and Development (AMED)
Japanese Governmental office
Japan
NO
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)
2015 | Year | 12 | Month | 25 | Day |
http://www.kuhp.kyoto-u.ac.jp/~seikeigeka/ekigaku/TRION.pdf
Unpublished
Completed
2015 | Year | 10 | Month | 20 | Day |
2016 | Year | 01 | Month | 27 | Day |
2018 | Year | 12 | Month | 31 | Day |
2019 | Year | 04 | Month | 30 | Day |
2019 | Year | 06 | Month | 30 | Day |
2019 | Year | 10 | Month | 30 | Day |
2015 | Year | 12 | Month | 25 | Day |
2019 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023495
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