CTS-1027 in Interferon-Naive Hepatitis C Patients

NCT ID: NCT00925990

Last Updated: 2012-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-07-31

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CTS-1027 + ribavirin

Study drug plus ribavirin

Group Type: EXPERIMENTAL

ribavirin

Intervention Type: DRUG

200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks

CTS-1027

Intervention Type: DRUG

5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks

CTS-1027 + placebo

Study drug plus placebo for ribavirin

Group Type: EXPERIMENTAL

CTS-1027

Intervention Type: DRUG

5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks

Placebo for ribavirin

Intervention Type: DRUG

Capsules identical to ribavirin in appearance containing inactive ingredients

Interventions

ribavirin

200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks

Intervention Type: DRUG

CTS-1027

5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks

Intervention Type: DRUG

Placebo for ribavirin

Capsules identical to ribavirin in appearance containing inactive ingredients

Intervention Type: DRUG

Other Intervention Names

Copegus

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conatus Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Castelloe, MD

Role: STUDY_CHAIR

Conatus Pharmaceuticals Inc.

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Medical Associates Research Group

San Diego, California, United States

Kaiser Permanante

San Diego, California, United States

VA Medical Center, San Diego

San Diego, California, United States

University of Colorado Health Science Center

Denver, Colorado, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Florida

Gainsville, Florida, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

University of MA Mem Med Ctr

Worchester, Massachusetts, United States

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

MN Clinical Research Center

Plymouth, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

St. Louis University

St Louis, Missouri, United States

Mount Sinai School of Medicine

New York, New York, United States

University of NC at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Health System

Durham, North Carolina, United States

Consultants of Clinical Research, Ohio GI and Liver Institute

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

VA Medical Center, Houston

Houston, Texas, United States

VCU-Medical College of Virginia

Richmond, Virginia, United States

Fundacion de Investigacion de Diego

Santurce, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

CTS-1027-03

Identifier Type: -

Identifier Source: org_study_id