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CirrhosisPhase 2NCT05309200

A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury

A Phase 2 study testing OCE-205 in people with Cirrhosis and Ascites, run by Ocelot Bio, Inc at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

OCE-205 is being tested to treat participants who have developed Hepatorenal Syndrome-Acute Kidney Injury as a complication of cirrhosis with ascites. The study aims are to evaluate the safety and efficacy of OCE-205 at various doses. Participants will receive treatment by intravenous infusion. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cirrhosis, Ascites, Hepatorenal Syndrome
What is being tested?
OCE-205
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
23 sitesin 2 countries
Study dates
28 Apr 2022to 13 Oct 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form (ICF) by participant or their legal/authorized representatives.
  • Diagnosed with decompensated cirrhosis with ascites.
  • Receiving albumin and has had appropriate diuretic withdrawal for at least 2 days prior to randomization into the study.
  • Beta-blockers should be discontinued 48 hours prior to randomization, unless doctor deems necessary for appropriate medical treatment.
  • No sustained improvement in renal function after both diuretic withdrawal and plasma volume expansion with albumin.
  • Female participants must have a negative pregnancy test prior to randomization and agree to avoid becoming pregnant during the study and for 30 days after the end of treatment. Male participants must agree to use 2 effective contraceptive methods during the study and up to 30 days after the end of treatment.

Who cannot join

  • Serum Creatinine >3.8 mg/dL.
  • Large volume paracentesis (LVP ≥6L) within 4 days of randomization.
  • Pulse oximeter reading of <90% on 2L or less.
  • Sepsis and/or uncontrolled bacterial infection.
  • Experienced shock within 72 hrs prior to screening.
  • Model for End-Stage Liver Disease (MELD) score >35.
Show all 19Show fewer
  • Hypertension with a Systolic BP > 140 mmHg and/ or a Diastolic BP >100 mmHg.
  • Treated with or exposed to nephrotoxic agents or has had exposure to radiographic contrast agents within 72 hrs prior to screening.
  • Has superimposed acute liver injury due to drugs, or toxins except for acute alcoholic hepatitis.
  • Proteinuria greater than 500 mg/dL.
  • Impaired cardiac function as evidenced by symptoms consistent with New York Heart Association Classification Class 2 or worse.
  • Received Renal Replacement Therapy (RRT) within 4 weeks of randomization.
  • Has had a Trans Jugular Intrahepatic Porto-systemic shunt (TIPS).
  • Pregnant or breastfeeding.
  • Diagnosed with a malignancy within the past 5 years.
  • History or current evidence of any condition (COVID-19 positive with respiratory/cardiac complications), therapy or laboratory abnormality that might confound the results of the study, interfere with the participation for the full duration of the study, or is not in the best interest to participate in the opinion of the investigator.
  • Participated in a study of an investigational medical product or device within the last 8 weeks preceding screening.
  • Experienced a major blood loss (≥500 mL) within the last 4 weeks prior to screening.
  • Is stuporous or comatose at screening (West Haven scores III and IV). exhibiting bradycardia.

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

United States22 sites

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02144

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern Medicine

    Chicago, Illinois, 60611

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • University of Missouri

    Columbia, Missouri, 65212

  • Baylor University

    Dallas, Texas, 75246

  • CHI St Luke's Health Baylor College of Medicine Medical Center

    Houston, Texas, 77030

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • New York-Presbyterian Hospital

    New York, New York, 10065

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Mayo Clinic - Phoenix

    Phoenix, Arizona, 85054

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Virginia Commonwealth University Health System

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California, San Francisco Liver Clinic

    San Francisco, California, 94143

  • Stanford Hospital

    Stanford, California, 94305

  • Tampa General Medical Group

    Tampa, Florida, 33606

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

Canada1 site

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Adaptive Dose-Ranging Study to Assess Safety and Efficacy of Intravenous OCE-205 in Adults Diagnosed With Cirrhosis With Ascites Who Have Developed Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI)

OCE-205 is being tested to treat participants who have developed Hepatorenal Syndrome-Acute Kidney Injury as a complication of cirrhosis with ascites.

The study aims are to evaluate the safety and efficacy of OCE-205 at various doses.

Participants will receive treatment by intravenous infusion. Participants will continue with this treatment until participants meets primary endpoint or any discontinuation criteria.

Read the detailed description

The study will include 5 treatment arms including 1 Placebo Arm and 4 active drug arms. Participants will be randomly selected to 1 of 5 arms.

  • Placebo
  • OCE-205 at 8 micrograms per hour (µg/hr)
  • OCE-205 at 15 micrograms per hour (µg/hr)
  • OCE-205 at 30 micrograms per hour (µg/hr)
  • OCE-205 at 50 micrograms per hour (µg/hr)

This multi-center trial will be conducted in the United States and Canada. If selected for the study, participants will be randomly assigned to 1 of the 5 treatment arms.

Being tested
OCE-205, Placebo
Keywords
HRS-AKI
Medical subject headings
Fibrosis, Ascites, Hepatorenal Syndrome, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OCE-205Drug

    The drug product, OCE-205, is a sterile solution to be used for intravenous infusion.

  • PlaceboDrug

    Placebo to match OCE-205 is a sterile solution to be used for intravenous infusion.

Study groups in NCT05309200
Study groupRoleWhat they receive
OCE-205 Cohort 1Placebo comparatorPlacebo, intravenous infusion
Receives: Drug: Placebo
OCE-205 Cohort 2ExperimentalOCE-205, 8 µg/hr, intravenous infusion
Receives: Drug: OCE-205
OCE-205 Cohort 3ExperimentalOCE-205, 15 µg/hr, intravenous infusion
Receives: Drug: OCE-205
OCE-205 Cohort 4ExperimentalOCE-205, 30 µg/hr, intravenous infusion
Receives: Drug: OCE-205
OCE-205 Cohort 5ExperimentalOCE-205, 50 µg/hr, intravenous infusion
Receives: Drug: OCE-205

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to measurement of concentration serum creatinine (sCr) value of less than 1.5 mg/dL on 2 consecutive days

    Measured: From Day 1 infusion start to Last Day of infusion end

Secondary outcomes (9)

  1. Mean Concentration of OCE-205 at Steady State Concentration (Css)

    Measured: From Day 1 infusion start to Last Day of infusion end

  2. Rate of Total Body Clearance (CL) of OCE-205

    Measured: From Day 1 infusion start to Last Day of infusion end

  3. Time to Elimination Half-Life (t1/2) of OCE-205

    Measured: From Day 1 infusion start to Last Day of infusion end

  4. Volume of Steady-State Volume of Distribution (Vss) of OCE-205

    Measured: From Day 1 infusion start to Last Day of infusion end

  5. Change in Mean Arterial Pressure (MAP) rate

    Measured: From Day 1 infusion start to Last Day of infusion end

  6. Percentage Change in rate of Mean Arterial Pressure (MAP)

    Measured: From Day 1 infusion start to Last Day of infusion end

  7. Change in Pulse Rate

    Measured: From Day 1 infusion start to Last Day of infusion end

  8. Percentage Change in Pulse Rate

    Measured: From Day 1 infusion start to Last Day of infusion end

  9. Change in concentration of Serum Creatinine (sCr)

    Measured: From Day 1 infusion start to Last Day of infusion end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2022
  2. Study start28 Apr 2022
  3. Primary completion12 Sep 2023
  4. Study completion13 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05309200
Sponsor's protocol ID
OCE-205-201
Status last verified
Dec 2023
First submitted
25 Mar 2022
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Angeli P, Gines P, Wong F, Bernardi M, Boyer TD, Gerbes A, Moreau R, Jalan R, Sarin SK, Piano S, Moore K, Lee SS, Durand F, Salerno F, Caraceni P, Kim WR, Arroyo V, Garcia-Tsao G. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. J Hepatol. 2015 Apr;62(4):968-74. doi: 10.1016/j.jhep.2014.12.029. Epub 2015 Jan 28. No abstract available.

    PubMed 25638527

  • Boyer TD, Sanyal AJ, Wong F, Frederick RT, Lake JR, O'Leary JG, Ganger D, Jamil K, Pappas SC; REVERSE Study Investigators. Terlipressin Plus Albumin Is More Effective Than Albumin Alone in Improving Renal Function in Patients With Cirrhosis and Hepatorenal Syndrome Type 1. Gastroenterology. 2016 Jun;150(7):1579-1589.e2. doi: 10.1053/j.gastro.2016.02.026. Epub 2016 Feb 16.

    PubMed 26896734

  • Cavallin M, Kamath PS, Merli M, Fasolato S, Toniutto P, Salerno F, Bernardi M, Romanelli RG, Colletta C, Salinas F, Di Giacomo A, Ridola L, Fornasiere E, Caraceni P, Morando F, Piano S, Gatta A, Angeli P; Italian Association for the Study of the Liver Study Group on Hepatorenal Syndrome. Terlipressin plus albumin versus midodrine and octreotide plus albumin in the treatment of hepatorenal syndrome: A randomized trial. Hepatology. 2015 Aug;62(2):567-74. doi: 10.1002/hep.27709. Epub 2015 Feb 13.

    PubMed 25644760

  • Gines P, Sola E, Angeli P, Wong F, Nadim MK, Kamath PS. Hepatorenal syndrome. Nat Rev Dis Primers. 2018 Sep 13;4(1):23. doi: 10.1038/s41572-018-0022-7.

    PubMed 30213943

  • Martin-Llahi M, Pepin MN, Guevara M, Diaz F, Torre A, Monescillo A, Soriano G, Terra C, Fabrega E, Arroyo V, Rodes J, Gines P; TAHRS Investigators. Terlipressin and albumin vs albumin in patients with cirrhosis and hepatorenal syndrome: a randomized study. Gastroenterology. 2008 May;134(5):1352-9. doi: 10.1053/j.gastro.2008.02.024. Epub 2008 Feb 14.

    PubMed 18471512

  • McClure T, Chapman B, Hey P, Testro A, Gow P. Long-term continuous terlipressin infusion in cirrhotic patients with hepatorenal syndrome or refractory ascites awaiting liver transplantation is associated with an increase in plasma sodium. United European Gastroenterol J. 2019 Nov;7(9):1271-1273. doi: 10.1177/2050640619878996. Epub 2019 Sep 19. No abstract available.

    PubMed 31700640

  • Robertson M, Majumdar A, Garrett K, Rumler G, Gow P, Testro A. Continuous outpatient terlipressin infusion for hepatorenal syndrome as a bridge to successful liver transplantation. Hepatology. 2014 Dec;60(6):2125-6. doi: 10.1002/hep.27154. Epub 2014 May 19. No abstract available.

    PubMed 24687396

  • Salerno F, Gerbes A, Gines P, Wong F, Arroyo V. Diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis. Postgrad Med J. 2008 Dec;84(998):662-70. doi: 10.1136/gut.2006.107789.

    PubMed 19201943

  • Sanyal AJ, Boyer T, Garcia-Tsao G, Regenstein F, Rossaro L, Appenrodt B, Blei A, Gulberg V, Sigal S, Teuber P; Terlipressin Study Group. A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome. Gastroenterology. 2008 May;134(5):1360-8. doi: 10.1053/j.gastro.2008.02.014. Epub 2008 Feb 13.

    PubMed 18471513

  • Wong F, Pappas SC, Curry MP, Reddy KR, Rubin RA, Porayko MK, Gonzalez SA, Mumtaz K, Lim N, Simonetto DA, Sharma P, Sanyal AJ, Mayo MJ, Frederick RT, Escalante S, Jamil K; CONFIRM Study Investigators. Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome. N Engl J Med. 2021 Mar 4;384(9):818-828. doi: 10.1056/NEJMoa2008290.

    PubMed 33657294

  • Vasudevan A, Ardalan Z, Gow P, Angus P, Testro A. Efficacy of outpatient continuous terlipressin infusions for hepatorenal syndrome. Hepatology. 2016 Jul;64(1):316-8. doi: 10.1002/hep.28325. Epub 2015 Dec 22. No abstract available.

    PubMed 26524479

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OCE-205 in people with Cirrhosis and Ascites, run by Ocelot Bio, Inc at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to measurement of concentration serum creatinine (sCr) value of less than 1.5 mg/dL on 2 consecutive days (time frame: From Day 1 infusion start to Last Day of infusion end). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05309200, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.

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