Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.
This is a multi-centre, randomized, double blind, parallel study design in patient admitted for flexor tendon repair in zone II.
The patients will undergo 9 visits within the time frame of the study. Patients will be randomized to receive treatment with PXL01 or standard care.
Primary objective is to assess total active motion based on PIP and DIP joints (TAM2) at 12-week visit. Secondary objectives are to assess TAM2 at all time points except for 12 weeks, TAM based on MCP, PIP, and DIP joints (TAM3) at all time points, Total Active Motion in DIP joint (DIPAM), tip-to-crease, grip strength and Total Passive Motion (TPM2 and TPM3).
Before any study-related assessment takes place, patients are given verbal and written information about the study and informed consent is achieved from the patient and/or legal guardian. The study should be carried out in accordance with the Clinical Study Protocol (CSP), ICH guidelines for Good Clinical Practise (GCP), and applicable regulatory requirements.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. |
|
| PXL01 | Experimental | PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXL01 | Drug | PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. |
| Measure | Description | Time Frame |
|---|---|---|
| TAM2 | The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints. | At 12 weeks after surgery |
Not provided
Not provided
Inclusion criteria:
Exclusion criteria
Treatment with any investigational product within 4 weeks of study entry
Patients previously included in the study
Thumbs with complete or partial division of flexor pollicis longus (FPL)
Concomitant fracture(s) requiring immobilisation
Injuries with associated soft tissue loss
Severe crush injury
Palmar plate injury requiring immobilisation
Devascularisation/requirement of vascular repair
Joint injuries
Bilateral injuries
Previous flexor tendon surgery in the digit, which is to be treated with IMP
Reduced motion in the digit, which is to be treated with IMP, or the corresponding digit prior to the injury
Compliance with mobilisation protocol not expected
Alcohol or drug abuse
Severe intercurrent illness, which in the opinion of the Investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study
Pregnant or lactating females
Fertile women who do not accept the consistent and correct use of highly effective methods of birth control defined as implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner during the first two weeks post-surgery. A condom alone is not considered an acceptable method for birth control, not even together with spermicide.
Known allergy to any component of the study product or placebo
Patients suffering from:
Or patients treated with:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Monica Wiig, MD, PhD | Dept. of Hand Surgery Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Hand Surgery, Aalborg Hospital | Aalborg | 9000 | Denmark | |||
| Dept. of Hand Surgery, Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25340801 | Derived | Wiig ME, Dahlin LB, Friden J, Hagberg L, Larsen SE, Wiklund K, Mahlapuu M. PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial. PLoS One. 2014 Oct 23;9(10):e110735. doi: 10.1371/journal.pone.0110735. eCollection 2014. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. Placebo: Placebo is a physiological sodium chloride solution, which is clear and colourless. |
| FG001 | PXL01 | PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. PXL01: PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
3 patients were treated with an incorrect mixture of IMP and were analyzed separately.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. Placebo is a physiological sodium chloride solution, which is clear and colourless. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | TAM2 | The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints. | FAS population | Posted | Median | Full Range | Degrees | At 12 weeks after surgery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. Placebo is a physiological sodium chloride solution, which is clear and colourless. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tendon rupture | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
High drop out rate leading to a low number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monica Wiig | Uppsala University Hospital | monica.wiig@akademiska.se |
Not provided
| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo is a physiological sodium chloride solution, which is clear and colourless. |
|
| Odense |
| 5000 |
| Denmark |
| Klinik für Handchirurgie der Herz- und Gefäß-Klinik GmbH | Bad Neustadt an der Saale | 97616 | Germany |
| Katholisches Klinikum Duisburg, St. Barbara Hospital, Klinik für Plastische Chirurgie und Handchirurgie | Duisburg | 47166 | Germany |
| St.Josef Hospital Essen- Kupferdreh, Abteilung für Handchirurgie | Essen | 45257 | Germany |
| Klinik für Plastische, Hand- und Wiederherstellungschirurgie, Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum des Saarlandes, Klinik für Unfall-, Hand - und Wiederherstellungschirugie | Homburg | 66421 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Sektion für Plastische Chirurgie, Handchirurgie und Intensiveinheit für Schwerbrandverletzte | Lübeck | 23538 | Germany |
| Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Innenstadt | Munich | 80336 | Germany |
| Ludwig-Maximilians Universität München, Klinik und Poliklinik für Plastische Chirurgie und Handchirurgie, Campus Großhadern | Munich | 81377 | Germany |
| Klinik für Handchirurgie, Mikrochirurgie und Rekonstruktive Brustchirurgie Vinzenz von Paul Kliniken GmbH | Stuttgart | 70199 | Germany |
| Dept. of Hand Surgery Sahlgrenska University Hospital | Gothenburg | SE-413 45 | Sweden |
| Dept. of Hand Surgery Malmö University Hospital | Malmö | SE-20502 | Sweden |
| Dept. of Hand Surgery, Stockholm South General Hospital | Stockholm | 118 83 | Sweden |
| Dept. of Hand Surgery Uppsala University Hospital, entrance 70 | Uppsala | SE-75185 | Sweden |
| BG001 |
| PXL01 |
PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.
|
|
|
| 9 |
| 70 |
| 22 |
| 70 |
| EG001 | PXL01 | PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound. | 10 | 65 | 22 | 65 |
| procedural pain | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| allergic urticaria | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| adhesion (resulting in tenolysis) | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| accidental death | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| myeloproliferative disorder | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| stroke | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Localised Infections | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
Not provided