January 1, 1997Thrombosis and Haemostasis

Pharmacodynamic and Safety Results of PEG-Hirudin in Healthy Volunteers

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Why the study?

Does PEG-Hirudin produce dose-dependent anticoagulant effects and safety in healthy volunteers?

Population

75 healthy volunteers

Comparison

PEG-Hirudin administered intravenously as a… vs Placebo

Design

RCT, randomized

Authors

HEHans‐Ulrich EsslingerAbbott (Germany)SHSylvia HaasVascular Medicine RMRobert MaurerPenn State Milton S. Hershey Medical Center

Discussion

Member takes

Implication

Supports evaluation for once-daily use in patients; extends volunteer data to guide Phase 2 dosing.

Structured PICO

Does PEG-Hirudin produce dose-dependent anticoagulant effects and safety in healthy volunteers?

Population

75 healthy volunteers

Intervention

PEG-Hirudin administered intravenously as a bolus injection (0.03-0.3 mg/kg), continuous infusion (0.01 and 0.02 mg/kg/h), or subcutaneously (0.05 to 0.6 mg/kg single dose, or 0.2 to 0.4 mg/kg once daily for 5 days)

Comparator

Placebo

Outcome

Anticoagulant effects (anti-IIa activity and APTT), safety, and pharmacodynamicssurrogate

PEG-Hirudin demonstrates prolonged, dose-dependent anticoagulant efficacy and safety in healthy volunteers, supporting its potential for once-daily subcutaneous administration.

Cite This Study

Esslinger et al. (1997) studied this question.

synapsesocial.com/papers/6a7046b72163a0a01bc47ef3 https://doi.org/10.1055/s-0038-1656077

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Pharmacodynamic and Safety Results of PEG-Hirudin in Healthy Volunteers

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Pharmacodynamic and Safety Results of PEG-Hirudin in Healthy Volunteers

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Also Consider

Also Consider