Clinical trial NCT00925990: CTS-1027 in Interferon-Naive Hepatitis C Patients
Official title: A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: HCV
interferon-naive
Lead sponsor: Conatus Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is intended to determine whether CTS-1027 either alone or in combination with ribavirin is safe and effective in Hepatitis C patients who have not previously been treated with interferon.

Detailed description: There are approximately 1 million Hepatitis C (HCV) patients in the US who have failed to respond to, or cannot tolerate, interferon or interferon plus ribavirin therapy. Significant adverse effects of interferon therapy include bone marrow depression (with reduced white blood cell and platelet counts) and major psychiatric disorders (especially depression). Ribavirin is associated with hemolytic anemia in a minority of patients who are treated with it. Patients with chronic HCV infection have a very low incidence of spontaneous viral clearance, have progressive disease, and have a continuing medical need for more efficacious and safer therapy. There is a significant unmet medical need for therapy in HCV patients who cannot (or will not) tolerate interferon-based treatment.

This trial will evaluate the effects of CTS-1027 with or without ribavirin in patients who are previously untreated with interferon including patients with major psychiatric disorders, uncontrolled autoimmune disease, and patients who simply decline treatment.

Eligibility criteria: Inclusion Criteria:

* Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the trial
* A history of chronic (\> 6 months duration) genotype 1 Hepatitis C (HCV) infection
* Unsuitable for interferon-based HCV treatment, defined as at least one of the following three criteria:

  * Contra-indicated for interferon treatment due to current or prior psychiatric disorders
  * Patient's decision to not pursue interferon-based therapy
  * In the opinion of the Principal Investigator, the patient is not a suitable candidate for interferon-based therapy
* a-fetoprotein (AFP) \<= 50 ng/mL
* Hemoglobin ≥ 12 g/dL, platelet count ≥ 100 x 109/L, and white blood cell count ≥ 1.5 x 109/L
* Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the trial.

Exclusion Criteria:

* Decompensated or severe liver disease defined by one or more of the following criteria:

  * Prothrombin time 3 seconds \> control
  * Direct bilirubin ≥ 1.5 x upper limit of normal range (ULN)
  * Serum albumin below normal limits
  * AST or ALT \> 7 x ULN at screening
  * Evidence of portal hypertension including:

    1. Varices on esophagogastroduodenoscopy (EGD) with or without a history of gastrointestinal bleeding; or
    2. Ascites
* Cirrhosis defined by one or both of the following criteria:

  * Liver biopsy showing cirrhosis
  * Other clinical signs and symptoms suggestive of cirrhosis
* Prior therapy for HCV with an interferon-based regimen
* Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
* Known history or presence of human immunodeficiency virus (HIV) infection
* Co-infection with hepatitis B virus (HBV)
* If female: pregnant, lactating, or positive serum pregnancy test
* Renal impairment (creatinine \> 1.5 x ULN), creatinine clearance \< 50 mL/min, or hepatorenal syndrome
* Hospitalization for liver disease within 60 days of screening
* Use of concomitant or prior drug therapy for HCV three months prior to screening
* Use of drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
* History of alcohol abuse (\> 50 g per day) within the past year
* History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose QT or QTc interval of \> 450 milliseconds
* Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for ten or more years
* Any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial.

Primary outcomes:
measure: Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Diego
country: United States
facility: Kaiser Permanante
state: California
city: San Diego
country: United States
facility: VA Medical Center, San Diego
state: California
city: Denver
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainsville
country: United States
facility: University of Florida
state: Florida
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Worchester
country: United States
facility: University of MA Mem Med Ctr
state: Massachusetts
city: Novi
country: United States
facility: Henry Ford Medical Center-Columbus
state: Michigan
city: Plymouth
country: United States
facility: MN Clinical Research Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: New York City
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of NC at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants of Clinical Research, Ohio GI and Liver Institute
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: VA Medical Center, Houston
state: Texas
city: Richmond
country: United States
facility: VCU-Medical College of Virginia
state: Virginia
city: Santurce
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Conatus Pharmaceuticals Inc.
name: Erin Castelloe, MD
role: STUDY_CHAIR
References: