Chronic Hepatitis C Genotype-1 RelapsePhase 2NCT00983060
Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients
A Phase 2 study testing NIM811 in people with Chronic Hepatitis C Genotype-1 Relapse, run by Novartis Pharmaceuticals at 16 sites in 7 countries.
Trial summary
This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Chronic Hepatitis C Genotype-1 Relapse
- What is being tested?
- NIM811
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 16 sitesin 7 countries
- Study dates
- Sep 2009to Apr 2011
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- chronic hepatitis C genotype-1
- HCV-RNA should be ≥ 4 x 105 IU/mL at screening
- Recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment, who subsequently becomes serum HCV RNA positive after stopping treatment ("relapser"). Patients must have been off all treatment for at least 3 months prior to start of study (Visit
Who cannot join
- Use of any HCV treatment ≤ 3months prior to study start
- Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV
- Women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception
- Pregnant or breastfeeding women
- Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or HIV infection
- Specified abnormalities in lab values of amongst others hemoglobin, WBC, ANC, platelets
- History of treatment for depression
- Steroid/immunosuppression drug use 3 months prior to study start Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
United States5 sites
Orlando Clinical Research Center
Orlando, Florida, 32809
Alamo Medical Research
San Antonio, Texas, 78215
Research and Education Inc.
San Diego, California, 92105
University Hepatitis Center
Sarasota, Florida, 34243
West Wind'r Research & Development LLC
Tampa, Florida, 33607
Australia3 sites
Novartis Investigative Site
Clayton, New South Wales
Novartis Investigative Site
Wentworthville, South Australia
Novartis Investigative Site
Westmead, New South Wales
Belgium2 sites
Novartis Investigative Site
Brussels
Novartis Investigative Site
Leuven, 3000
Spain2 sites
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Seville
Taiwan2 sites
Novartis Investigative Site
Kaohsiung City
Novartis Investigative Site
Taipei, ROC
About this study
Official title: A Randomized, Adaptive-design, Dose-finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With the Standard of Care (SOC) in Relapsed Patients Infected With HCV Genotype-1
This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.
- Conditions
- Chronic Hepatitis C Genotype-1 Relapse
- Being tested
- NIM811, Placebo BID + SOC
- Keywords
- NIM811, chronic hepatitis, chronic hepatitis C, chronic hepatitis C genotype-1, HCV, HCV-1, relapser
- Medical subject headings
- Hepatitis, Chronic, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIM811Drug
BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)
Placebo BID + SOCDrug
Placebo BID + SOC (PEG IFN and RBV)
| Study group | Role | What they receive |
|---|---|---|
| NIM811 | Experimental | Not described Receives: Drug: NIM811 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo BID + SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC
Measured: 4 weeks
Secondary outcomes (4)
To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks
Measured: 12 weeks
To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC
Measured: 4 weeks
To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1
Measured: 3 weeks, 5 weeks
To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12)
Measured: 12 weeks after cessation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2011
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 Chronic Hepatitis C Genotype-1 RelapseStudies 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
- 59 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
- NCT00983060
- Sponsor's protocol ID
- CNIM811B2202
- Other IDs
- EUDRACT number: 2009-009995-11
- Status last verified
- Feb 2017
- First submitted
- 22 Sep 2009
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
Lawitz E, Godofsky E, Rouzier R, Marbury T, Nguyen T, Ke J, Huang M, Praestgaard J, Serra D, Evans TG. Safety, pharmacokinetics, and antiviral activity of the cyclophilin inhibitor NIM811 alone or in combination with pegylated interferon in HCV-infected patients receiving 14 days of therapy. Antiviral Res. 2011 Mar;89(3):238-45. doi: 10.1016/j.antiviral.2011.01.003. Epub 2011 Jan 19.
PubMed 21255610
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Adaptive-design, Dose-finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With the Standard of Care (SOC) in Relapsed Patients Infected With HCV Genotype-1
- ClinicalTrials.gov ID
- NCT00983060
- Acronym / sponsor ID
- CNIM811B2202
- Conditions
- Chronic Hepatitis C Genotype-1 Relapse
- Keywords
- NIM811, chronic hepatitis, chronic hepatitis C, chronic hepatitis C genotype-1, HCV, HCV-1, relapser
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- First posted
- 23 Sep 2009 (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 study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIM811 | Experimental | Drug: NIM811 |
| Placebo | Placebo comparator | Drug: Placebo BID + SOC |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- chronic hepatitis C genotype-1
- HCV-RNA should be ≥ 4 x 105 IU/mL at screening
- Recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment, who subsequently becomes serum HCV RNA positive after stopping treatment ("relapser"). Patients must have been off all treatment for at least 3 months prior to start of study (Visit
Key exclusion criteria (8 listed)
- Use of any HCV treatment ≤ 3months prior to study start
- Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV
- Women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception
- Pregnant or breastfeeding women
- Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or 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 |
|---|---|---|
| NIM811BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV) | Drug | NIM811 |
| Placebo BID + SOCPlacebo BID + SOC (PEG IFN and RBV) | Drug | Placebo |
Primary outcome
To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC
Time frame: 4 weeks
4 secondary outcomes
To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks
Time frame: 12 weeks
To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC
Time frame: 4 weeks
To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1
Time frame: 3 weeks, 5 weeks
To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12)
Time frame: 12 weeks after cessation of treatment
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 19 Dec 2020.
- Results publication: PubMed 21255610Lawitz E, Godofsky E, Rouzier R, Marbury T, Nguyen T, Ke J, Huang M, Praestgaard J, Serra D, Evans TG. Safety, pharmacokinetics, and antiviral activity of the cyclophilin inhibitor NIM811 alone or in combination with pegylated interferon in HCV-infected patients receiving 14 days of therapy. Antiviral Res. 2011 Mar;89(3):238-45. doi: 10.1016/j.antiviral.2011.01.003. Epub 2011 Jan 19.
- Results for CNIM811B2202 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NIM811 in people with Chronic Hepatitis C Genotype-1 Relapse, run by Novartis Pharmaceuticals at 16 sites in 7 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 4 inclusion and 8 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia, Belgium, Spain, Taiwan and 2 more countries. 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?
To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC (time frame: 4 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 NCT00983060, 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 19 Dec 2020.