Hepatitis CPhase 2NCT00925990
CTS-1027 in Interferon-Naive Hepatitis C Patients
A Phase 2 study testing ribavirin and CTS-1027 in people with Hepatitis C, run by Conatus Pharmaceuticals Inc. at 21 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- ribavirin and CTS-1027
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Jun 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 (> 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
Show all 9Show fewer
- 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.
Who cannot join
- 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:
Show all 24Show fewer
- Varices on esophagogastroduodenoscopy (EGD) with or without a history of gastrointestinal bleeding; or
- 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.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of NC at Chapel Hill
Chapel Hill, North Carolina, 27599
Consultants of Clinical Research, Ohio GI and Liver Institute
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
University of Colorado Health Science Center
Denver, Colorado, 80262
Duke University Health System
Durham, North Carolina, 27710
University of Florida
Gainsville, Florida, 32610
VA Medical Center, Houston
Houston, Texas, 77030
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Mount Sinai School of Medicine
New York, New York, 10029
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
MN Clinical Research Center
Plymouth, Minnesota, 55446
VCU-Medical College of Virginia
Richmond, Virginia, 23298
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Medical Associates Research Group
San Diego, California, 92123
Kaiser Permanante
San Diego, California, 92154
VA Medical Center, San Diego
San Diego, California, 92161
St. Louis University
St Louis, Missouri, 63104
Washington Hospital Center
Washington D.C., District of Columbia, 20010
University of MA Mem Med Ctr
Worchester, Massachusetts, 01655
About this study
Official title: A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients
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.
Read the 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
- Being tested
- ribavirin, CTS-1027, Placebo for ribavirin
- Keywords
- HCV, interferon-naive
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ribavirinDrug
Also called Copegus
200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks
CTS-1027Drug
5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks
Placebo for ribavirinDrug
Capsules identical to ribavirin in appearance containing inactive ingredients
| Study group | Role | What they receive |
|---|---|---|
| CTS-1027 + ribavirin | Experimental | Study drug plus ribavirin Receives: Drug: ribavirin; Drug: CTS-1027 |
| CTS-1027 + placebo | Experimental | Study drug plus placebo for ribavirin Receives: Drug: CTS-1027; Drug: Placebo for ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as "viral load") levels in the blood from before treatment (baseline) through 24 weeks of treatment.
Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)
Measured: Baseline and 24 weeks
Secondary outcomes (1)
Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment
Mean absolute changes in ALT (alanine aminotransferase)in the blood from before treatment (baseline)through 24 weeks of treatment are presented.
Mean absolute change in ALT (IU/ml)= ALT(Week 24) - ALT(baseline)
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Castelloe, MD, Study chair, Conatus Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925990
- Sponsor's protocol ID
- CTS-1027-03
- Status last verified
- Feb 2012
- First submitted
- 19 Jun 2009
- Last updated
- 27 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT00925990
- Acronym / sponsor ID
- CTS-1027-03
- Conditions
- Hepatitis C
- Keywords
- HCV, interferon-naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Conatus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Posted 27 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTS-1027 + ribavirin | Experimental | Drug: ribavirin, Drug: CTS-1027Study drug plus ribavirin |
| CTS-1027 + placebo | Experimental | Drug: CTS-1027, Drug: Placebo for ribavirinStudy drug plus placebo for ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (24 listed)
- Decompensated or severe liver disease defined by one or more of the following criteria:
- Cirrhosis defined by one or both of the following criteria:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ribavirinAlso: Copegus200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks | Drug | CTS-1027 + ribavirin |
| CTS-10275 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks | Drug | CTS-1027 + placebo, CTS-1027 + ribavirin |
| Placebo for ribavirinCapsules identical to ribavirin in appearance containing inactive ingredients | Drug | CTS-1027 + placebo |
Primary outcome
Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment
Time frame: Baseline and 24 weeks
Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as "viral load") levels in the blood from before treatment (baseline) through 24 weeks of treatment. Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)
1 secondary outcome
Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Castelloe, MD study chair
Conatus Pharmaceuticals Inc.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ribavirin and CTS-1027 in people with Hepatitis C, run by Conatus Pharmaceuticals Inc. at 21 sites in 2 countries.
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 9 inclusion and 24 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 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Puerto Rico. 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. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2012.