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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01346215
Other study ID # HEPBER0211
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received April 28, 2011
Last updated April 29, 2011
Start date October 2011
Est. completion date February 2012

Study information

Verified date April 2011
Source Laboratório Químico Farmacêutico Bergamo Ltda.
Contact Marcelo A. C. Orlandi , Dr.
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 132
Est. completion date February 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients research that agree to participate in the study and sign the informed consent form;

- Patients aged over 18 years, both sexes, regardless of color or social class;

- Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;

- Patients with laboratory results within specified acceptance criteria.

Exclusion Criteria:

- Patients who are taking part or took part in another clinical investigational study within 12 months;

- Hypersensitivity to heparin sodium and/or benzyl alcohol;

- History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;

- History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;

- Severe liver disease;

- Patients in cancer treatment;

- Pregnant and lactating women;

- Use of glucocorticoids over physiological dose;

- Use of other anticoagulants;

- Patients undergoing any surgery performed less than 15 days;

- History of non response or exacerbated response to heparin sodium;

- Patients who do not adapt to 150 UI/kg dose.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Intervention

Biological:
heparin sodium
5000 UI/mL
heparin sodium
5000 UI/mL

Locations

Country Name City State
Brazil Instituto de Nefrologia de Campinas Campinas São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Laboratório Químico Farmacêutico Bergamo Ltda. L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis 4 weeks (12 consecutive sessions) No
Secondary Pharmacodynamic activity of heparin observed through aPTT marker 4 weeks (sessions 1, 6 and 12) No
Secondary Safety in use of heparin by monitoring adverse events 5 weeks (12 consecutive sessions + 1 post treatment session) Yes
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