Study of CTS-1027 in Hepatitis C Patients

NCT00570336 | Completed Phase 2 DMC

• 1 other identifier: CTS-1027-01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 19

Brief Summary

The purpose of this study is to determine if CTS-1027 can lower elevated liver enzymes in patients with chronic HCV infection.

Conditions

Chronic Hepatitis C Virus Infection

Keywords

HCV; HCV treatment failure; Elevated aminotransferases

Outcome Measures

Primary Outcomes (2)

• Number of adverse events at each dose level

  4 to 24 weeks

• Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) levels at each dose

  4-24 Weeks

Secondary Outcomes (1)

• Peak and trough levels of CTS-1027 in plasma

  4 to 24 weeks

Study Arms (5)

2.5 milligram (mg) CTS-1027

EXPERIMENTAL

2.5 mg CTS-1027

Drug: CTS-1027

5 mg CTS-1027

EXPERIMENTAL

5 mg CTS-1027

Drug: CTS-1027

10 mg CTS-1027

EXPERIMENTAL

10 mg CTS-1027

Drug: CTS-1027

30 mg CTS-1027

EXPERIMENTAL

30 mg CTS-1027

Drug: CTS-1027

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CTS-1027 DRUG

Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd (quaque die, once daily).

10 mg CTS-1027; 2.5 milligram (mg) CTS-1027; 30 mg CTS-1027; 5 mg CTS-1027

Placebo OTHER

Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 HCV infection
• Unsuccessful HCV treatment defined as one or more of the following criteria:
• Failure to achieve a virologic response during previous therapy, or
• Failure to tolerate therapy, or
• Failure to maintain a sustained virologic response, or
• In the opinion of the Principal Investigator, the patient is not a suitable candidate for interferon based therapy
• Liver impairment, as defined by either aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels 1.5 - 7 x ULN on at least two occasions, seven or more days apart, during the baseline period
• Alpha-fetoprotein (AFP) \<= 50 ng/mL
• Hemoglobin \>= 10 g/dL, platelet count \>= 75 x 109/L, and white blood cell count \>= 1.5 x 109/L
• Willingness to utilize adequate contraception (if female, evidenced by being postmenopausal for at least 6 months or using contraceptive pill; for both females and males, being surgically sterile, or using two forms of barrier contraception) from screening to at least one month after the completion of the trial.

You may not qualify if:

• Decompensated or severe liver disease defined by one or more of the following criteria:
• Prior liver biopsy showing cirrhosis
• Prior liver biopsy showing bridging fibrosis (Metavir \>2 or Ishak \>3) more than 2 years ago in the absence of newer liver biopsy results
• Prothrombin time: 3 seconds \> control
• Total bilirubin \>= 1.5 x Upper limit of the normal range (ULN), or \> 3 x ULN for unconjugated bilirubin
• Serum albumin below normal limits
• AST or ALT \> 7 x ULN during baseline period
• Evidence of portal hypertension including:
• Splenomegaly or evidence of portal hypertension (i.e., enlarged portal vein and varices) on ultrasound,
• Varices in esophagogastroduodenoscopy (EGD); or
• Ascites
• 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 or urine pregnancy test

Sponsors & Collaborators

• Conatus Pharmaceuticals Inc.: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (19)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Kaiser Permanente

San Diego, California, 92154, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Digestive Healthcare of Georgia

Atlanta, Georgia, 30309, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

West Bloomfield, Michigan, 48322, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10019, United States

Location

Bronx VA Medical Center

The Bronx, New York, 10468, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Consultants of Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Advanced Liver Therapies - Baylor College of Medicine

Houston, Texas, 77030, United States

Location

VAMC - Baylor College of Medicine

Houston, Texas, 77030, United States

Location

McGuire Hospital DVAMC

Richmond, Virginia, 23249, United States

Location

Study Officials

• William Frank, MD

  Conatus Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 10, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 16, 2010

Record last verified: 2010-09

Locations

US (19)