A clinical experimental study to evaluate the benefits and risks of PF-06865571 alone and when coadministered with PF-05221304 in patients with Non alcoholic hepatitis (NASH)and Fibrosis
Phase 2
Not yet recruiting
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2020/10/028440
- Lead Sponsor
- Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
(1)Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
(2)BMI more than or equal to 22.5kg/m2
Exclusion Criteria
(1)Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
(2)Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
(3)unstable liver function tests, recent cardiovascular event(s) significant malignancies,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resolution of NASH without worsening of fibrosis or improvement in fibrosis by 1 more than or equal or both and Proportion of participants achieving resolution of NASH without worsening of fibrosis or improvement in fibrosis by more than or equal to 1 stage without worsening of NASH or bothTimepoint: Time Frame: Week 48
- Secondary Outcome Measures
Name Time Method