Single Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
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|ClinicalTrials.gov Identifier: NCT05490888|
Recruitment Status : Recruiting
First Posted : August 8, 2022
Last Update Posted : September 13, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis, Liver Liver Fibrosis Ascites Hepatic||Drug: PHIN-214 Subcutaneous injection||Phase 1|
Terlipressin has been shown to reduce portal hypertension, improve renal function, and induce natriuresis in cirrhotic patients with ascites without hepatorenal syndrome (HRS). It is approved in Europe for the treatment of bleeding esophageal varices and HRS type 1 and is usually administered as an IV bolus.
This study is an open label, First in Human study of PHIN-214. PHIN-214 is a terlipressin derivative administered subcutaneously. It is a partial V1a agonist which is designed to reduce splanchnic blood pooling and portal hypertension. A resultant increase in systemic pressure and renal arterial pressure may increase kidney perfusion and creatinine clearance. As a partial V1a agonist that traffics into the bloodstream from a subcutaneous depot, this derivative is designed to be gentler than terlipressin and has been well tolerated at the injection site, to date.
This study will evaluate the use of PHIN-214 administered once at various dosing levels to establish the maximum tolerated dose in patients with compensated and decompensated cirrhosis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Single Dose Escalation Study of PHIN-214 in Compensated and Decompensated Cirrhotic Patients|
|Actual Study Start Date :||January 3, 2022|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||February 28, 2023|
Experimental: single dose of PHIN-214
single ascending dose of PHIN-214
Drug: PHIN-214 Subcutaneous injection
Single subcutaneous injection with PHIN-214 terlipressin derivative, single ascending dose
Other Name: Terlipressin derivative
- Incidence of dose limiting toxicities [ Time Frame: up to two weeks ]Incidence of dose limiting toxicities
- incidence of stopping criteria [ Time Frame: up to two weeks ]incidence of stopping criteria
- incidence of AEs [ Time Frame: up to two weeks ]incidence of AEs
- PK of PHIN-214 [ Time Frame: up to two weeks ]plasma concentration of PHIN-214
- AUC of PHIN-214 [ Time Frame: up to two weeks ]AUC of PHIN-214
- PK of PHIN-214 metabolite [ Time Frame: up to two weeks ]plasma concentration of PHIN-214 metabolite
- AUC of PHIN-214 metabolite [ Time Frame: up to two weeks ]AUC of PHIN-214 metabolite
- various exploratory markers of efficacy [ Time Frame: up to two weeks ]systolic and diastolic blood pressure
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Body mass index within the range 18 to 40 kg/m2 (inclusive) at screening.
- Females must be non-pregnant, non-lactating or of non-childbearing potential or using highly efficient contraception for the full duration of the study.
- Patients with liver cirrhosis confirmed by reliable biopsy (within 12 months) or reliable Fibroscan >15 kPa at screening.
- 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.
- History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
- Significant kidney disease
- Estimated glomerular filtration rate (eGFR by CKD-Epi) <60 ml/min/1.73 m2 or Cr >2.0 mg/dL.
- Hepatic encephalopathy ≥ grade 1.
- Recipient of a transjugular intrahepatic portosystemic shunt (TIPS).
- Known positive HIV serology confirmed by HIV viral load.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05490888
|Contact: Cynthia C Jones, BS||206-568-1450 ext *firstname.lastname@example.org|
|United States, Arizona|
|Arizona Liver Health||Recruiting|
|Chandler, Arizona, United States, 85224|
|Contact: Angie Coste, FNP-C 480-470-4000 email@example.com|
|Principal Investigator: Naim Alkhouri, MD|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Douglas Simonetto, MD 507-284-4824 Simonetto.firstname.lastname@example.org|
|Principal Investigator: Douglas Simonetto, MD|
|Study Chair:||Cynthia C Jones, BS||PharmaIN|
|Other Study ID Numbers:||
|First Posted:||August 8, 2022 Key Record Dates|
|Last Update Posted:||September 13, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Diseases