Blinded study on efficacy, safety and tolerability of a single dose of rhBMP6 mixed with patient's own blood and synthetic ceramics in adult patients for the treatment of post-traumatic tibial non-unio

Phase 1

• Conditions: The treatment of non-union of the tibia; MedDRA version: 20.0Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.0Level: PTClassification code 10017088Term: Fracture nonunionSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2021-004034-11-AT
• Lead Sponsor: Genera Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-05
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Patients meeting ALL of the following criteria at screening will be eligible for participation in the study:
1.Willing and able to provide informed consent and to comply with study requirements. Written informed consent must be obtained before any study assessments are done. Patients must be fluent in the language that is spoken by the investigator and the trial staff and in which the informed consent is written.
2.Skeletally mature male or female, age =18 years. Females of childbearing potential must use a highly effective method of birth control within 1 year following surgery, be willing to extend the use for additional year, if needed, and must have a negative urine pregnancy test prior to randomization.
3.The diagnosis of tibial non-union as a consequence of traumatic,
unilateral, displaced, isolated, closed extra-articular fracture of the tibia
previously treated with osteosynthetic device, confirmed by medical
history and radiographic analyses. A patient is non-responsive to
conservative and/or alternative treatment (e.g., electrical stimulation,
ultrasound, skeletal fixation with or without supplemental bone graft),
and there is a lack of evidence of healing progression over previous 3
months.
4.Otherwise in good general condition in the investigator's opinion, based on vital signs, full physical examination, standard clinical laboratory tests, ECG findings at screening.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Patients meeting ANY of the following criteria at screening will NOT be
eligible for participation in the study:
1. Documented titanium allergy or intolerance.
2. History of bilateral bone graft harvesting from the iliac crest.
3. Previous treatment with bone morphogenetic proteins (e.g.,
INDUCTOS/INFUSE or OSIGRAFT/OPGENRA/OP-1).
4. Active systemic infection.
5. Presence of neuropathy, which in the investigator’s opinion can
interfere with walking or appreciation of pain.
6. Presence or history of pathological fractures or osteomalacia.
7. Known active malignancy, history of malignancy (except for fully
resected basal cell carcinoma of the skin), or ongoing treatment with
antineoplastic agents or radiation therapy.
8. Presence of poorly controlled diabetes mellitus as evident from
hemoglobin A1c >8% at screening.
9. History of autoimmune disease of connective tissue (e.g., rheumatoid
arthritis, systemic lupus erythematosus, Sjögren’s syndrome), or
other chronic disease or condition treated with
immunosuppressants.
10. History of severe symptomatic osteoarthritis or other chronic
disease or condition associated with frequent or prolonged use of
nonsteroidal anti-inflammatory drugs (NSAIDs).
11. History of alcohol or drug dependence, or a positive urine drug
screen at screening which cannot be explained by medication history
and current smokers unless they are willing to quit smoking during
the six months period following surgery.
12. Treatment with platelet aggregation inhibitors within 5 days (for
clopidogrel) or 7 days (for low-dose acetylsalicylic acid) prior to
surgery.
13. Treatment with systemic corticosteroids within 1 week, or with
immunosuppressants (e.g., methotrexate) within 2 weeks prior to
surgery.
14. Treatment with an investigational drug within 6 months or 5 half-lives of the drug (whichever is longer) prior to surgery.
15. Presence of any other disease or condition which in the
investigator’s opinion represents a high safety risk for surgery, or
interferes with patient’s ability to comply with study procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified