Chronic Hepatitis C Genotype-1 Relapse Clinical Trial
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
| NCT number | NCT00983060 |
| Other study ID # | CNIM811B2202 |
| Secondary ID | EUDRACT number: |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | September 2009 |
| Verified date | February 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 59 |
| Est. completion date | |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 69 Years |
| Eligibility | Inclusion criteria: 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 Exclusion criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Clayton | New South Wales |
| Australia | Novartis Investigative Site | Wentworthville | South Australia |
| Australia | Novartis Investigative Site | Westmead | New South Wales |
| Belgium | Novartis Investigative Site | Brussels | |
| Belgium | Novartis Investigative Site | Leuven | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Puerto Rico | Fundacion de Investigacion de Diego | San Juan | |
| Spain | Novartis Investigative Site | Barcelona | |
| Spain | Novartis Investigative Site | Sevilla | |
| Taiwan | Novartis Investigative Site | Kaohsiung | |
| Taiwan | Novartis Investigative Site | Taipei | ROC |
| United States | Orlando Clinical Research Center | Orlando | Florida |
| United States | Alamo Medical Research | San Antonio | Texas |
| United States | Research and Education Inc. | San Diego | California |
| United States | University Hepatitis Center | Sarasota | Florida |
| United States | West Wind'r Research & Development LLC | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Australia, Belgium, Germany, Puerto Rico, Spain, Taiwan,
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 p — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC | 4 weeks | ||
| Secondary | 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 | 12 weeks | ||
| Secondary | To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC | 4 weeks | ||
| Secondary | To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 | 3 weeks, 5 weeks | ||
| Secondary | 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) | 12 weeks after cessation of treatment |