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Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
St. Paul, Minnesota, 55114 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Biliary Liver Cirrhosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Men and nonlactating and nonpregnant women greater than or equal to 18 years of age

- Subjects with biopsy proven primary biliary cirrhosis (PBC) disease in the
asymptomatic or symptomatic phase of PBC.

- Otherwise healthy as determined by the investigator on the basis of medical history,
physical examination, clinical laboratory test results (other than those associated
with PBC), vital signs, and 12-lead electrocardiogram (ECG).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with a recent increase in bilirubin, bilirubin >15 mg/dL, presence of
ascites, esophageal varices, or hepatic encephalopathy.

- Any major illness that in the investigator's judgment will substantially increase the
risk associated with the subject's participation in the study

- Any malignancy including hepatocellular carcinoma.

NCT00406237
Pfizer
Completed
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

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[email protected]

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