A Phase 1 Single Dose Escalation Study of PHIN-214 in Compensated Cirrhotic Patients

Overview

About this study

The purpose of this study is to establish the Maximum Tolerated Dose (MTD), assess the safety, tolerability, and pharmacokinetics of subcutaneous PHIN-214 in participants with compensated and decompensated cirrhosis. In addition, various exploratory markers of effectiveness will be analyzed. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Body mass index within the range 18 to 40 kg/m2 (inclusive) at screening.

2. Females must be non-pregnant, non-lactating or of non-childbearing potential or using
highly efficient contraception for the full duration of the study.

3. Patients with liver cirrhosis confirmed by reliable biopsy (within 12 months) or
reliable Fibroscan >15 kPa at screening.

Exclusion Criteria:

1. Significant abnormalities in medical history or on physical examination, including:
respiratory disease requiring therapy or history of respiratory failure,
cardiovascular disease or hypertension, electrocardiogram abnormalities or history of
significant EKG abnormalities.

2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone
secretion, or any other disorder associated with fluid or sodium imbalance.

3. Significant kidney disease

4. Estimated glomerular filtration rate (eGFR by CKD-Epi) <60 ml/min/1.73 m2 or Cr >2.0
mg/dL.

5. Hepatic encephalopathy ≥ grade 1.

6. Recipient of a transjugular intrahepatic portosystemic shunt (TIPS).

7. Known positive HIV serology confirmed by HIV viral load.

8. Patients with acute hepatitis B; patients with known chronic hepatitis B are eligible
if treatment regimen is not changed in the 4 weeks prior to study inclusion

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/18/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Douglas Simonetto, M.D.

Open for enrollment

Contact information:

Amy Olofson R.N.

(507) 538-6547

Olofson.Amy@mayo.edu

More information

Publications

Publications are currently not available