Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)

Venous Thromboembolism Clinical Trial

Official title:

A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Weeks Extended VTE Prophylaxis With Daily Oral Doses of TTP889 After One Week of Standard Prophylactic Treatment Following Hip Fracture Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119457
• Other study ID #: TTP889-201
• Secondary ID: Eudract CT#2004-
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2005
• Last updated: June 2, 2009
• Start date: January 2005
• Est. completion date: April 2006

Study information

• Verified date: June 2009
• Source: vTv Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyNorway: Norwegian Medicines AgencyDenmark: Danish Medicines AgencyCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.

Description:

FIXIT is the first Phase 2 study of TTP889. The trial is a proof-of-concept study to determine the safety and antithrombotic efficacy of TTP889 in patients at risk for venous thromboembolism (VTE). The study is a multi-center, randomized, double-blind, parallel-group evaluation of 300 mg TTP889 or placebo, administered orally once daily for three weeks, in patients who have undergone surgery to repair unilateral fracture of the upper third of either femur and who have completed 5 to 9 days of postoperative prophylactic treatment for VTE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have undergone reparative surgery within 72 hours after unilateral hip fracture, defined as fracture of the upper third of either femur

• Must have started standard prophylactic treatment for VTE with low molecular weight heparin (LMWH) or heparin before surgery or within 24 hours after hip fracture surgery, and continued treatment with LMWH or heparin for at least five days, but not more than nine days, after surgery

• Last dose of LMWH or heparin must have been administered at least 12 hours, but not more than 48 hours, before dosing with study drug

• Females must have a negative serum pregnancy test

• Must weigh at least 45 kg

• Must demonstrate the mental and physical ability and willingness to follow all study-specific instructions

• Must be able to read, comprehend and sign the Ethics Committee-approved informed consent form

Exclusion Criteria:

• Evidence of active bleeding

• Clinical signs of VTE

• Any medical requirement for (or intention to use) continued anticoagulation after randomization through the end of study

• History of intracranial bleeding, hemorrhagic stroke, or gastrointestinal bleeding within 3 months of study start

• Presence of active malignant disease

• Hip fracture associated with multiple trauma, that places patient at excessive risk for hemorrhage or organ system failure, or that may make it difficult or impossible to perform bilateral lower limb venography

• Intention to take aspirin at doses greater than 325 mg/day

• Hemoglobin < 5.45 mmol/L (9 g/dL), hematocrit < 29%, or a platelet count < 100,000/mL at the screening visit

• Elevated ALT or AST level > 3.0 times the ULN, or an elevated total bilirubin > 1.5 the ULN at the screening visit

• Creatinine > 180 mmol/L (2.0 mg/dL) at the screening visit

• Any other laboratory value at screening that the Investigator considers to be clinically significant and warrants exclusion from the study

• Patient is currently breast feeding a child and wishes to continue breast feeding

• Previous allergy to contrast material or any other contraindications to perform bilateral lower limb venography

• The use of another investigational drug within 28 days of study entry

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Embolism
• Embolism and Thrombosis
• Hip Fractures
• Thromboembolism
• Thrombosis
• Venous Thromboembolism

Intervention

Drug:
• TTP889

Locations

Country	Name	City	State
Czech Republic	Nemocnice Ceske Budejovice, Urazove oddeleni	Ceske Budejovice
Czech Republic	FN s Poliklinikou Ostrava, Traumatologicke Centrum	Ostrava-Poruba
Czech Republic	FN Motol, Ortopedicka Klinicka UK 2.LF a FN Notol	Praha 5
Czech Republic	FN Na Bulovce, Ortopedicka Klinika IPVZ a 1.LF UK ORT, Budinova 2	Praha 8
Czech Republic	VFN, I. Chirurgicka klinika	Praha-2
Denmark	AAlborg Hospital	Aalborg
Denmark	Ortopaedkirurgisk Klinik, Farso	Farso
Denmark	Amtsygehuset i Gentofte	Hellerup
Denmark	KAS Herlev	Herlev
Denmark	Horsholm Hospital	Horsholm
Denmark	H:S Bispebjerg Hospital	Kobenhavn
Denmark	Silkeborg Hospital	Silkeborg
Norway	Orthopedics, Alesund Sykehus	Alesund
Norway	Skyehuset Innlandet HF	Gjovik
Norway	Skyehuset Innlandet HF	Lillehammer
Norway	Halfdan Wilhelmsens Alle 17	Tonsberg
Sweden	Ortoped Kliniken, Sahlgrenska Universitetssjukhus, Ostra	Goteborg
Sweden	Ortopedsektionen, Kirurgkliniken, Kungalvs Sjukhus	Kungalv
Sweden	Ortoped kliniken, Sahlgrenska Universitetssjukhus	Molndal
Sweden	Ortoped kliniken, NU-sjukvarden, Udevalla Sjukhus	Udevalla
Sweden	Ortoped kliniken, Sjukhuset i Varberg	Varberg

Sponsors (1)

Lead Sponsor	Collaborator
vTv Therapeutics

Countries where clinical trial is conducted

Czech Republic,  Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the antithrombotic efficacy of TTP889, administered once daily for three weeks, in patients who have completed standard prophylactic treatment for deep vein thrombosis after hip fracture surgery.
Primary	Evaluation of safety of once daily oral administration of TTP889 for three weeks
Secondary	To assess the correlation between peak and trough plasma concentrations of TTP889 and clinical safety and efficacy outcomes.