A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension

Completed · Phase 2

Conditions studied: Liver Cirrhosis, Hepatic Cirrhosis, Portal Hypertension

In brief

This is an open-label pilot study to evaluate the safety, tolerability, and efficacy of IDN-6556 in treating portal hypertension in subjects with liver cirrhosis.

Key facts

Study ID

NCT02230683

Run by

Conatus Pharmaceuticals Inc.

People needed

23

Starts

2014-08-01

Expected to finish

2015-06-01

Last updated by the study team

2016-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
• Clinical, radiological, or biochemical evidence of liver cirrhosis
• Evidence of portal hypertension as evidenced by any of the following:
• Splenomegaly, on imaging and/or clinical evaluation, with platelet count of <120,000 at study entry, or
• Presence of small sized varices on screening endoscopy and/or collateral circulation on imaging, or
• Presence of medium/large varices that have never bled and have been obliterated with endoscopic ligation
• Portal hypertension defined as a hepatic venous pressure gradient (HVPG) >5 mmHg at Screening
• Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug.

You may not qualify if…

• Decompensated cirrhosis as defined by the presence of overt ascites (requiring diuretics), overt encephalopathy (requiring specific therapy), or history of variceal hemorrhage.
• Known infection with HIV
• Hepatic failure defined as total bilirubin ≥12 mg/dL
• Other non-liver organ failure, including:
• Renal failure defined as creatinine ≥ 2.0 mg/dL
• Cerebral failure defined as hepatic encephalopathy grade III or IV
• Coagulation failure defined as INR ≥ 2.5 or platelets ≤ 20x109/L
• Hemodynamic requirement for inotropic support
• Child-Pugh score of 10-15 (Child-Pugh C classification)
• Use of vasoactive drugs (at or within 3 months of Screening) that may impair hepatic blood flow; examples include but are not limited to:
• β-blockers, including carvedilol
• Nitrates
• Vasopressin (or analogues)
• Phosphodiesterase inhibitors (prescribed daily for pulmonary hypertension; p.r.n. use for erectile dysfunction is permitted)
• Change in dose or regimen within 3 months of Screening of:
• Fibrates or statins
• Angiotensin II receptor antagonist or angiotensin converting enzyme (ACE) inhibitor
• Use of the following drugs within 2 months of Screening:
• Systemic corticosteroids
• Pentoxifylline
• Known or suspected use of illicit drugs or drugs of abuse (allowed if medically prescribed or indicated)
• Concomitant pancreatitis
• Evidence of portal vein thrombosis on Doppler ultrasound of the portal vasculature
• Active inflammatory bowel disease
• Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)

Where it is running

• VA Connecticut Healthcare System — West Haven, Connecticut, United States
• Johns Hopkins Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• North Shore University Hospital — Manhasset, New York, United States
• New York University Lagone Medical Center — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• St. Luke's Health Baylor College of Medicine — Houston, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Utah Hospital — Salt Lake City, Utah, United States
• Bon Secours Mary Immaculate Hospital — Newport News, Virginia, United States
• Bon Secours St. Mary's Hospital — Richmond, Virginia, United States
• McGuire DVAMC — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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