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Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

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NCT03248882

Last updated on March 27, 2020
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Study Location
Franco Felizarta MD
Bakersfield, California, 93301 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
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.
Show details

- Body Mass Index >= 25 kg/m2

- Body Weight > 50 kg

- Liver fat (assessed via MRI-PDFF) >= 8%

- Biopsy-proven NASH - diagnosed in previous 24-months

- Presumed NASH - per Sponsor's definition

- NAFLD with minimal inflammation/fibrosis

- Features of Metabolic Syndrome

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Alcohol-induced steatohepatitis or other forms of chronic liver disease

- Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus

- Severe Renal Impairment

- Contraindications for MRI

NCT03248882
Pfizer
Completed
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

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Descriptive Information
Brief Title  ICMJE Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Official Title  ICMJE A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-05221304 ADMINISTERED DAILY FOR 16-WEEKS TO ADULT SUBJECTS WITH NONALCOHOLIC FATTY LIVER DISEASE
Brief Summary Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Detailed Description A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For 16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.

Masking: Double (Participant, Investigator)
Masking Description:

Double-Blind

Primary Purpose: Treatment

Condition  ICMJE
  • Nonalcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: PF-05221304
    PF-05221304, Experimental Drug
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Double-Blind, PF-05221304-matching Placebo
    Intervention: Drug: Placebo
  • Active Comparator: PF-05221304 - 2 mg
    PF-05221304 - 2 mg, once-daily
    Intervention: Drug: PF-05221304
  • Active Comparator: PF-05221304 - 10 mg
    PF-05221304 - 10 mg, once-daily
    Intervention: Drug: PF-05221304
  • Active Comparator: PF-05221304 - 25 mg
    PF-05221304 - 25 mg, once-daily
    Intervention: Drug: PF-05221304
  • Active Comparator: PF-05221304 - 50 mg
    PF-05221304 - 50 mg, once-daily
    Intervention: Drug: PF-05221304
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2019) 		305
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017) 		360
Actual Study Completion Date  ICMJE March 27, 2019
Actual Primary Completion Date February 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body Mass Index >= 25 kg/m2
  • Body Weight > 50 kg
  • Liver fat (assessed via MRI-PDFF) >= 8%
  • Biopsy-proven NASH - diagnosed in previous 24-months
  • Presumed NASH - per Sponsor's definition
  • NAFLD with minimal inflammation/fibrosis
  • Features of Metabolic Syndrome

Exclusion Criteria:

  • Alcohol-induced steatohepatitis or other forms of chronic liver disease
  • Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus
  • Severe Renal Impairment
  • Contraindications for MRI
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Israel,   Poland,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248882
Other Study ID Numbers  ICMJE C1171002
2017-001156-55 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2020

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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