A Phase 3 interventional study of Fondaparinux in Thromboembolism, sponsored by GlaxoSmithKline. Completed at 1 site. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-09-04.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
This study is requested by PMDA to confirm the efficacy and the safety for HFS.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 48 is below the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rate of Major Bleeding During Treatment Period
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
Time frame: From the first study drug injection up to Day 17
Rate of PE During Treatment Period
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
Time frame: Up to Day 17
Rate of DVT During Treatment Period
Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
Time frame: Up to Day 17
Rate of Proximal DVT During Treatment Period
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
Time frame: Up to Day 17
Rate of Distal Only DVT During Treatment Period
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
Time frame: Up to Day 17
Number of Participants With Major Bleeding During Treatment Period
Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall \>=2 grams per deciliter (g/dL, 1.6 millimoles per liter \[mmol/L\]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from \>=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) \>=2. Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS).
Time frame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)
Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS. Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context. Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor.
Time frame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death
An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Time frame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
Number of Transfused Participants
Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.
Time frame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
Summary of Units Transfused
Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.
Time frame: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)
Rate of Symptomatic DVT
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
Time frame: Up to Day 17
Total of 48 participants undergoing major orthopedic surgery of the lower limb such as hip fracture surgery, knee replacement surgery and hip replacement surgery were enrolled from 16 February 2006 to 26 October 2006 at 9 centers in Japan. The safety population consisted of 48 participants and full analysis set consisted of 37 participants.
| Milestone | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Started | 48 |
| Completed | 42 |
| Not completed | 6 |
| Withdrew: Adverse event | 3 |
| Withdrew: Other | 3 |
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
| % of normalized events per participant | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Rate of Major Bleeding During Treatment Period | 21.6 (9.8 to 38.2) |
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
| % of normalized events per participant | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Rate of PE During Treatment Period | 0 (0 to 0) |
Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
| % of normalized events per participant | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Rate of DVT During Treatment Period | 21.6 |
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
| % of normalized events per participant | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Rate of Proximal DVT During Treatment Period | 2.6 |
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
| % of normalized events per participant | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Rate of Distal Only DVT During Treatment Period | 21.6 |
Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall \>=2 grams per deciliter (g/dL, 1.6 millimoles per liter \[mmol/L\]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from \>=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) \>=2. Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS).
| Participants | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Number of Participants With Major Bleeding During Treatment Period | 0 |
Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS. Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context. Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor.
| Participants | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Minor Bleeding | 0 |
| Any Bleeding | 0 |
An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
| Participants | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Any AE | 37 |
| Any SAE | 2 |
| Death | 0 |
Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.
| Participants | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Number of Transfused Participants | 1 |
Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.
| mL | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Summary of Units Transfused | 280 |
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.
| % of normalized events per participant | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Rate of Symptomatic DVT | 0 |
Collected over AE and SAE were reported throughout the study (from the first study drug injection up to 2 days after the last study drug injection [approximately up to Day 17]).. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fondaparinux Sodium 2.5 mg s.c. | 0/48 (0%) | 2/48 (4.2%) | 37/48 (77.1%) |
| Event | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| IleusGastrointestinal disorders | 1/48 |
| Femur fractureInjury, poisoning and procedural complications | 1/48 |
| Event | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| ConstipationGastrointestinal disorders | 8/48 |
| InsomniaPsychiatric disorders | 8/48 |
| Oedema peripheralGeneral disorders | 4/48 |
| ExcoriationInjury, poisoning and procedural complications | 4/48 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 4/48 |
| RestlessnessPsychiatric disorders | 3/48 |
| PyrexiaGeneral disorders | 3/48 |
| Blood alkaline phosphatase increasedInvestigations | 3/48 |
| Abdominal pain upperGastrointestinal disorders | 2/48 |
| DiarrheaGastrointestinal disorders | 2/48 |
| Age, Continuous(Years) | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Mean | 76.6 ± 14.4 |
| Sex: Female, Male(Participants) | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Female | 40 |
| Male | 8 |
| Region of Enrollment(Participants) | Fondaparinux Sodium 2.5 mg s.c. |
|---|---|
| Japan | 48 |
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