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Chronic Hepatitis C Virus InfectionPhase 2NCT00570336

Study of CTS-1027 in Hepatitis C Patients

A Phase 2 study testing CTS-1027 in people with Chronic Hepatitis C Virus Infection, run by Conatus Pharmaceuticals Inc. at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C Virus Infection
What is being tested?
CTS-1027
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
19 sitesUnited States
Study dates
Dec 2007to Jul 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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
  • 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:
  • drugs with presumed anti-HCV activity in the prior three months
  • corticosteroids in the past 30 days
  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Consultants of Clinical Research

    Cincinnati, Ohio, 45219

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Advanced Liver Therapies - Baylor College of Medicine

    Houston, Texas, 77030

  • VAMC - Baylor College of Medicine

    Houston, Texas, 77030

  • Scripps Clinic

    La Jolla, California, 92037

  • University of Miami

    Miami, Florida, 33136

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Mt. Sinai School of Medicine

    New York, New York, 10019

  • McGuire Hospital DVAMC

    Richmond, Virginia, 23249

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Kaiser Permanente

    San Diego, California, 92154

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Bronx VA Medical Center

    The Bronx, New York, 10468

  • Henry Ford Health System

    West Bloomfield, Michigan, 48322

Other trials in United States

About this study

Official title: A Dose Response Study of CTS-1027 in Hepatitis C Patients

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

Read the 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.

Being tested
CTS-1027, Placebo
Keywords
HCV, HCV treatment failure, Elevated aminotransferases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTS-1027Drug

    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).

  • PlaceboOther

    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.

Study groups in NCT00570336
Study groupRoleWhat they receive
2.5 milligram (mg) CTS-1027Experimental2.5 mg CTS-1027
Receives: Drug: CTS-1027
5 mg CTS-1027Experimental5 mg CTS-1027
Receives: Drug: CTS-1027
10 mg CTS-1027Experimental10 mg CTS-1027
Receives: Drug: CTS-1027
30 mg CTS-1027Experimental30 mg CTS-1027
Receives: Drug: CTS-1027
PlaceboPlacebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events at each dose level

    Measured: 4 to 24 weeks

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

    Measured: 4-24 Weeks

Secondary outcomes (1)

  1. Peak and trough levels of CTS-1027 in plasma

    Measured: 4 to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00570336
Sponsor's protocol ID
CTS-1027-01
Status last verified
Sep 2010
First submitted
6 Dec 2007
Last updated
16 Sep 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CTS-1027 in people with Chronic Hepatitis C Virus Infection, run by Conatus Pharmaceuticals Inc. at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events at each dose level (time frame: 4 to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00570336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2010.

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