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
NCT ID: NCT00983060
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NIM811
NIM811
BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)
Placebo
Placebo BID + SOC
Placebo BID + SOC (PEG IFN and RBV)
Interventions
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NIM811
BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)
Placebo BID + SOC
Placebo BID + SOC (PEG IFN and RBV)
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
18 Years
69 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Research and Education Inc.
San Diego, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
University Hepatitis Center
Sarasota, Florida, United States
West Wind'r Research & Development LLC
Tampa, Florida, United States
Alamo Medical Research
San Antonio, Texas, United States
Novartis Investigative Site
Clayton, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Wentworthville, South Australia, Australia
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Frankfurt, , Germany
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Seville, , Spain
Novartis Investigative Site
Taipei, ROC, Taiwan
Novartis Investigative Site
Kaohsiung City, , Taiwan
Countries
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References
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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.
Related Links
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Results for CNIM811B2202 from the Novartis Clinical Trials website
Other Identifiers
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EUDRACT number: 2009-009995-11
Identifier Type: -
Identifier Source: secondary_id
CNIM811B2202
Identifier Type: -
Identifier Source: org_study_id