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A Hepatic Impairment Study for PF-04965842.

Last updated on March 19, 2019

FOR MORE INFORMATION
Study Location
Orlando Clinical Research Center
Orlando, Florida, 32809 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatic Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110
pounds).

- Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Additional Inclusion Criteria for subjects with hepatic impairment:

- Satisfy the criteria for Class A or Class B of the Child Pugh classification (mild:
Child Pugh Scores 5 to 6 points, and moderate: Child Pugh Scores 7 to 9 points),
within 14 days of investigational product administration.

- A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to
any acute ongoing hepatocellular process) documented by medical history, physical
examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or
magnetic resonance imaging (MRI).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with clinically significant infections within the past 3 months (for example,
those requiring hospitalization, or as judged by the Investigator), evidence of any
infection (including influenza) within the past 7 days, history of disseminated herpes
simplex infection or recurrent (>1 episode) or disseminated herpes zoster.

- Subjects with a malignancy or with a history of malignancy, with the exception of
adequately treated or excised non metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.

Additional exclusion criteria for subjects with hepatic impairment:

- Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
(defined as less than 1 year).

- Subjects who have previously had a transplanted kidney, liver, or heart.

- At Screening, persistent severe, uncontrolled hypertension.

NCT03626415
Pfizer
Recruiting
A Hepatic Impairment Study for PF-04965842.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now