Hepatitis C, ChronicPhase 2NCT00088140
A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients
A Phase 2 study testing IDN-6556 in people with Hepatitis C, Chronic, run by Conatus Pharmaceuticals Inc. at 15 sites in United States.
Trial summary
The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- IDN-6556
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2004to Oct 2005
- 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
- Chronic hepatitis C infection
- Unsuccessful prior HCV treatment
- Liver impairment (either AST or ALT 1.5-10.0 x ULN)
- Alpha-fetoprotein <= 50 ng/mL
- Adequate hematologic parameters
Who cannot join
- Decompensated or severe liver disease
- Hepatocellular carcinoma
- HIV infection
- Co-infection with hepatitis B virus (HBV)
- Renal impairment
- Pancreatitis
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- Use of illicit or drugs of abuse
- History of alcohol abuse
- Presence of clinically significant cardiac arrhythmias
- If female, pregnant or lactating
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02215
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Cincinnati
Cincinnati, Ohio, 45267
Metrohealth Medical Center
Cleveland, Ohio, 44109
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27715
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Scripps Clinic
La Jolla, California, 92067
University of Miami
Miami, Florida, 33136
Mt. Sinai School of Medicine
New York, New York, 10029
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Medical College of Virginia
Richmond, Virginia, 23298
The Mayo Clinic
Rochester, Minnesota, 55905
California Pacific Medical Center
San Francisco, California, 94115
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients
The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.
- Conditions
- Hepatitis C, Chronic
- Being tested
- IDN-6556, Placebo
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDN-6556Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| IDN-6556 5 mg twice a day (BID) | Active comparator | Not described Receives: Drug: IDN-6556 |
| IDN-6556 25mg twice a day (BID) | Active comparator | Not described Receives: Drug: IDN-6556 |
| IDN-6556 50 mg twice a day (BID) | Active comparator | Not described Receives: Drug: IDN-6556 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10
Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2004 (estimated)
- Study startJul 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conatus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Idun Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088140
- Sponsor's protocol ID
- CL-000006556-PRO-0007
- Status last verified
- Aug 2012
- First submitted
- 20 Jul 2004
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT00088140
- Acronym / sponsor ID
- CL-000006556-PRO-0007
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Conatus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Idun Pharmaceuticals
- Study start
- Jul 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 21 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| IDN-6556 5 mg twice a day (BID) | Active comparator | Drug: IDN-6556 |
| IDN-6556 25mg twice a day (BID) | Active comparator | Drug: IDN-6556 |
| IDN-6556 50 mg twice a day (BID) | Active comparator | Drug: IDN-6556 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic hepatitis C infection
- Unsuccessful prior HCV treatment
- Liver impairment (either AST or ALT 1.5-10.0 x ULN)
- Alpha-fetoprotein <= 50 ng/mL
- Adequate hematologic parameters
Key exclusion criteria (10 listed)
- Decompensated or severe liver disease
- Hepatocellular carcinoma
- HIV infection
- Co-infection with hepatitis B virus (HBV)
- Renal impairment
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 |
|---|---|---|
| IDN-6556 | Drug | IDN-6556 25mg twice a day (BID), IDN-6556 5 mg twice a day (BID), IDN-6556 50 mg twice a day (BID) |
| Placebo | Drug | Placebo |
Primary outcome
Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10
Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IDN-6556 in people with Hepatitis C, Chronic, run by Conatus Pharmaceuticals Inc. at 15 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 5 inclusion and 10 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 13 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10. 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?
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 13 Aug 2012.