Hepatitis CPhase 2NCT01387958
A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients
A Phase 2 study testing LCQ908 in people with Hepatitis C, run by Novartis Pharmaceuticals at 2 sites in New Zealand.
Trial summary
This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- LCQ908
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Jul 2011to Feb 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3).
- No prior therapy or inadequate response to therapy for hepatitis C.
- Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.
Who cannot join
- Use of other investigational drugs within at least 30 days of enrollment
- Women of child-bearing potential.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Novartis Investigative Site
Auckland
Novartis Investigative Site
Christchurch
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Multi-center Trial, to Determine the Safety and Antiviral Effect of 14 Days of LCQ908 Monotherapy in Hepatitis C Infected Patients
This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.
- Conditions
- Hepatitis C
- Being tested
- LCQ908, Placebo
- Keywords
- Hepatitis C virus, Chronically infected, treatment naive, non responders to prior therapy
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCQ908Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| LCQ908 | Experimental | Not described Receives: Drug: LCQ908 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Change in hepatitis C viral load as assessed by PCR
Measured: 2 weeks
Secondary outcomes (2)
Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.
Measured: 28 days
Measure: LCQ908 concentrations in the blood
Measured: over 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Terminated early due to futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387958
- Sponsor's protocol ID
- CLCQ908A2214
- Status last verified
- May 2012
- First submitted
- 1 Jul 2011
- Last updated
- 8 May 2012
- Results posted
- No
Publications
Gane E, Stedman C, Dole K, Chen J, Meyers CD, Wiedmann B, Zhang J, Raman P, Colvin RA. A Diacylglycerol Transferase 1 Inhibitor Is a Potent Hepatitis C Antiviral in Vitro but Not in Patients in a Randomized Clinical Trial. ACS Infect Dis. 2017 Feb 10;3(2):144-151. doi: 10.1021/acsinfecdis.6b00138. Epub 2016 Nov 8.
PubMed 27788579
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Multi-center Trial, to Determine the Safety and Antiviral Effect of 14 Days of LCQ908 Monotherapy in Hepatitis C Infected Patients
- ClinicalTrials.gov ID
- NCT01387958
- Acronym / sponsor ID
- CLCQ908A2214
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C virus, Chronically infected, treatment naive, non responders to prior therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to futility
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Jul 2011 (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.
This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCQ908 | Experimental | Drug: LCQ908 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent.
- Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3).
- No prior therapy or inadequate response to therapy for hepatitis C.
- Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.
Key exclusion criteria (3 listed)
- Use of other investigational drugs within at least 30 days of enrollment
- Women of child-bearing potential.
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| LCQ908 | Drug | LCQ908 |
| Placebo | Drug | Placebo |
Primary outcome
Measure: Change in hepatitis C viral load as assessed by PCR
Time frame: 2 weeks
2 secondary outcomes
Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.
Time frame: 28 days
Measure: LCQ908 concentrations in the blood
Time frame: over 21 days
Results and safety
The study was stopped early (reason given: Terminated early due to futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- Derived from this study: PubMed 27788579Gane E, Stedman C, Dole K, Chen J, Meyers CD, Wiedmann B, Zhang J, Raman P, Colvin RA. A Diacylglycerol Transferase 1 Inhibitor Is a Potent Hepatitis C Antiviral in Vitro but Not in Patients in a Randomized Clinical Trial. ACS Infect Dis. 2017 Feb 10;3(2):144-151. doi: 10.1021/acsinfecdis.6b00138. Epub 2016 Nov 8.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 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 LCQ908 in people with Hepatitis C, run by Novartis Pharmaceuticals at 2 sites in New Zealand.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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 was stopped early (reason given: Terminated early due to futility). Results are not available in the source record.
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?
Measure: Change in hepatitis C viral load as assessed by PCR (time frame: 2 weeks). 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 NCT01387958, which also lists 1 linked publication.
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 8 May 2012.