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Trial record 1 of 1 for:    CTS-1027-01
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Study of CTS-1027 in Hepatitis C Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00570336
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : September 16, 2010
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by:
Conatus Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus Infection Drug: CTS-1027 Other: Placebo Phase 2

Detailed Description:
Randomized, placebo-controlled, double-blind, parallel group, multicenter, dose response trial utilizing four doses of CTS-1027, administered orally once daily, in outpatients with chronic hepatitis C virus (HCV) infection.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Response Study of CTS-1027 in Hepatitis C Patients
Study Start Date : December 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2.5 milligram (mg) CTS-1027
2.5 mg CTS-1027
Drug: CTS-1027
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).

Experimental: 5 mg CTS-1027
5 mg CTS-1027
Drug: CTS-1027
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).

Experimental: 10 mg CTS-1027
10 mg CTS-1027
Drug: CTS-1027
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).

Experimental: 30 mg CTS-1027
30 mg CTS-1027
Drug: CTS-1027
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).

Placebo Comparator: Placebo
Placebo
Other: Placebo
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.




Primary Outcome Measures :
  1. Number of adverse events at each dose level [ Time Frame: 4 to 24 weeks ]
  2. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) levels at each dose [ Time Frame: 4-24 Weeks ]

Secondary Outcome Measures :
  1. Peak and trough levels of CTS-1027 in plasma [ Time Frame: 4 to 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 HCV infection
  • Unsuccessful HCV treatment defined as one or more of the following criteria:

    1. Failure to achieve a virologic response during previous therapy, or
    2. Failure to tolerate therapy, or
    3. Failure to maintain a sustained virologic response, or
    4. 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.

Exclusion Criteria:

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

    1. Prior liver biopsy showing cirrhosis
    2. Prior liver biopsy showing bridging fibrosis (Metavir >2 or Ishak >3) more than 2 years ago in the absence of newer liver biopsy results
    3. Prothrombin time: 3 seconds > control
    4. Total bilirubin >= 1.5 x Upper limit of the normal range (ULN), or > 3 x ULN for unconjugated bilirubin
    5. Serum albumin below normal limits
    6. AST or ALT > 7 x ULN during baseline period
    7. 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
  • Last baseline AST and ALT level prior to Day 1 of < 1.5 x ULN
  • Renal impairment (creatinine > 1.5 x ULN) or hepatorenal syndrome
  • Pancreatitis
  • Hospitalization for liver disease within 60 days of screening
  • Use of concomitant or prior drug therapy for HCV at screening, including the use of:

    1. drugs with presumed anti-HCV activity in the prior three months
    2. corticosteroids in the past 30 days
    3. potentially hepatotoxic drugs in the past 30 days (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin)
  • Use of illicit or drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
  • History of alcohol abuse 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570336


Locations
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Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
FGK Clinical Research GmbH
Investigators
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Study Director: William Frank, MD Conatus Pharmaceuticals Inc.

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Responsible Party: MiRa Huyghe, Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00570336    
Other Study ID Numbers: CTS-1027-01
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010
Keywords provided by Conatus Pharmaceuticals Inc.:
HCV
HCV treatment failure
Elevated aminotransferases
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic